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The EDQM website contains a number of files and forms, which can be downloaded using Microsoft Word (DOC) or Adobe PDF (Portable Document Format) format. To access PDF files you need to have a copy of Acrobat Reader on your computer, which is available free of charge from Adobe (see http://www.adobe.com). To open a document, simply click on its link and wait until your computer has downloaded the document.
Note: The official email address ends "@edqm.eu" (replaces "@pheur.org").
- EDQM HealthCare European Pharmacopoeia & PDG Certification OMCL Activities & Guidelines Publications, Products Events organised by the EDQM HelpDesk
- How to reach us (December 2008)
- Plan d\'accès DEQM (décembre 2008)
- Presentation material
- General
- EDQM Brochure
- Annual Report of Activities
- Annual Report Activities 2008
- Annual Report Activities 2007
- Annual Report Activities 2006
- Annual Report Activities 2005
- Annual Report Activities 2004
- Annual Report activities 2003
- Annual Report activities 2002
- Annual Report activities 2001
- Corrigendum - Annual Report Activities 2001 - Biological Standardisation
- Annual Report activities 2000
- Annual Report activities 1999
- Press releases
- Latest issue
- Press archives
- 2010
- 2009
- The EDQM continues its inspections in China
- PDG Meeting, 26-29 October 2009
Pharmacopoeial Discussion Group (PDG) meeting, St. Louis, Missouri, 26-29 October 2009 - European Organ Donation Day, 4 October, Berlin, Germany
- DSO Press Release 11th EODD (German version)
- DSO Press Release 11th EODD
- 134th Session of the European Pharmacopoeia Commission, Strasbourg
- 134e session de la Commission Européenne de Pharmacopée, Strasbourg
- World Blood Donor Day
- Journée Mondiale du donneur de sang
- PDG Meeting, 7-11 June 2009
Pharmacopoeial Discussion Group (PDG) meeting, Yokohama, Japan, 7-11 June 2009 - GDP Réunion, 7-11 juin 2009
Groupe de Discussion des Pharmacopées (GDP), Yokohama, Japon, 7-11 juin 2009 - OMCL Annual Seminar, 25-29 May 2009
14th Annual Meeting of European Network of Official Medicines Control Laboratories (OMCL), Vienna, Austria, 25-29 May 2009 - Réunion annuelle des Autorités Nationales de Pharmacopée et de la Pharmacopée Européenne, 11-12 mai
- National Pharmacopoeia Authorities Annual Meeting, 11-12 May
- Assemblée annuelle du Réseau Réseau Européen des Laboratoires OMCL, 25-29 mai 2009
- EDQM establishes confidentiality agreements with US-FDA and TGA
- Utilisation clinique optimale des composants sanguins, 24-25 avril
- Optimal clinical use of blood components, 24-25 April
International Symposium, 24-25 April 2009, Wilbad Kreuth (Germany) - Appointments April 2009
- Nominations Avril 2009
- 133rd Session of the European Pharmacopoeia Commission Held in Strasbourg
- 133e session de la Commission Européenne de Pharmacopée, Strasbourg
- 135th Session of the European Pharmacopoeia Commission, Strasbourg
- 2008
- Press Releases 2008 Archives (English)
- Communiqués de presse 2008 Archives (Francais)
- Counterfeit medicines, 9 December 2008
Communication empowers the public to participate in minimising health risks - Médicaments de contrefacon, 9 Décembre 2008
La communication renforce la capacité du grand public à participer à la réduction des risques sanitaires - 132ème session de la Commission européenne de Pharmacopée
- 132nd Session PhEur Commission, 28 November 2008
- Counterfeit medicines - Model for a network, 17 March 2008
- PDG Meeting, 10-13 November 2008
Pharmacopoeial Discussion Group (PDG) meeting, Brussels, Belgium, 10-13 November 2008 - GDP Reunion, 10-13 novembre 2008
Groupe de Discussion des Pharmacopées (GDP), Bruxelles, Belgique, 10-13 novembre 2008 - Russian Federation and EDQM
- La Federation de Russie et la DEQM
- Pharmaceutical Reference Substance Press Release
- Etalons de reference pharmaceutique
- 10th European Day for Organ Donation and Transplantation
- 10ème Journée Européenne du don d\'organe et de la greffe
- Rencontre entre la DEQM et des representants du Projet de Pharmacopee Chilienne
- Meeting EDQM & representatives Chilean Pharmacopoeia Project
- 2nd Workshop on the Characterisation of Heparin Products, 19-20 June 2008
- 2eme Atelier sur la caracteristion de produits hepariniques
- Revised heparin monographs adopted
- Les monographies révisées des héparines
- 131st Session PhEur Commission, 27 June 2008
- 131eme Session de la Commission Européenne de Pharmacopée, 27 juin 2008
- Training on best practices to combat counterfeiting, 11 June 2008
- Session de formation sur les meilleures pratiques pour combattre la contrefacon, 11 juin 2008
- OMCL Annual Seminar, 2-6 June 2008
13th Annual Meeting of European Network of Official Medicines Control Laboratories (OMCL), Strasbourg, France, 2-6 June 2008 - Assemblée annuelle du Réseau Réseau Européen des Laboratoires OMCL, 2-6 juin 2008
- PDG Meeting, 1-5 June 2008
Pharmacopoeial Discussion Group (PDG) meeting, Portland, USA, 1-5 June 2008 - GDP Reunion, 1-5 juin 2008
Groupe de Discussion des Pharmacopées (GDP), Portland, Etats-Unis, 1-5 juin 2008 - La DEQM participe à une rencontre internationale sur les héparines, 13 mai 2008
- EDQM saddened by death of Peter Castle, 14 May 2008
- Tristesse de la DEQM à l\'annonce de la Disparition de Peter Castle, 14 mai 2008
- EDQM participates in meeting on heparins, 13 May 2008
- Meeting EDQM & Indian Authorities, 30 April 2008
- Réunion entre la DEQM & les authorités indiennes, 30 avril 2008
- Alternatives to Animal Testing, Dubrovnik, Croatia, 23-24 April 2008
- Remplacement des essais sur animaux, Dubrovnik, Croatie, 23-24 avril 2008
- 130th Session PhEur Commission, 18 March 2008
- 130eme Session de la Commission Européenne de Pharmacopée, 18 mars 2008
- New observer to PhEur, 6 March 2008
- Nouvel observateur PhEur, 6 mars 2008
- New Blood Transfusion Guide, 4 March 2008
- Nouveau Guide Transfusion Sanguine, 4 mars 2008
- EDQM French language website, 11 February 2008
- Version française du site Internet de la DEQM, 11 février 2008
- 2007
- Press Releases 2007 Archives
- PDG Meeting, 28 Oct - 1 Nov 07
Pharmacopoeial Discussion Group (PDG) meeting, Yokohama, Japan, 28 Oct - 1 Nov 2007 - Réunion GDP, 28 Oct-1 Nov 07
- 9th European day Organ Donation & Transplantation
09/10/2007 - EDQM Director appointed
Council of Europe appoints new Director of the EDQM - New Frontiers in the Q of Medicines, Strasbourg, France, 13-15 June 2007
26/07/2007 - European Cooperation & Synergy in QS beyond the European Pharmacopoeia, 15-16 June 2007
- Reference Standards - Agreement with ShFDA & SIFDC
English and Chinese Text - Reference Standards - Agreement with ShFDA & SIFDC
English and Frecnh Text - OMCL Annual Seminar, 7-11 May 07
12ème réunion annuelle du réseau européen des laboratoires officiels de contrôle des médicaments (OMCL), Prague, République Tchèque, 7-11 mai 2007 - PDG Meeting, 7-10 May 07
Pharmacopoeial Discussion Group (PDG) meeting, Brussels, Belgium, 7-10 May 2007 - Meeting of CD-P-TO & Chair elected, 25 April 2007
Meeting of the European Committee on Organ Transplantation & Chair elected - Réunion du CD-P-TO & Président, 25 avril 2007
- National Pharmacopoeia Secretariats, 23-24 April 2007
Annual meeting of national Pharmacopoeia secretariats, 23-24 April 2007, Rijeka, Croatia - Meeting of CD-P-TS & Chair elected, 28 March 2007
Meeting of the European Committee on Blood Transfusion & Chair elected - Réunion du CD-P-TS & Président, 28 mars 2007
- New Chair PhEur Commission, 27 March 2007
Election of the new Chair of the European Pharmacopoeia Commission - Memo of Understanding, 20 March 2007
EDQM and HPFB of Health Canada sign Memo of Understanding - Inauguration building, 19 March 2007
Inauguration of the new EDQM building, 19 March 2007 - New observer to PhEur, 20 Feb 2007
The Republic of Belarus - New Name EDQM, Jan 2007
The EDQM has become the EDQM & HealthCare
- 2006
- 2006 Press Releases Archives
- 5th Edition Online version available in Spanish
- EDQM_Team_Visit_China
Multidisciplinary EDQM team on official journey to China, 17-29 June 2006 - PDG Meeting, 23-25 October 2006
Pharmacopoeial Discussion Group (PDG) meeting, Chicago, USA, 23-25 October 2006 - Avian Influenza Symposium, 19-20 Oct 2006
Press Release - Requirements for production and control of avian influenza vaccines, 19-20 October 2006 - Microbiology Symposium, 2-3 Oct 2006
Press Release - New Microbiology Chapters of the European Pharmacopoeia, 2-3 October 2006 - Impurities Symposium, 21-22 Sept 2006
Press Release - Impurities control : setting specifications for antibiotics and peptides, 21-22 September 2006 - New observers, 29 June 2006
The Russian Federation & the Republic of Kazakhstan - PDG Meeting, 5-8 June 2006
Pharmacopoeial Discussion Group (PDG) meeting, Yokohama, Japan, 5-8 June 2006 - OMCL Annual Seminar 9-12 May 2006
11th Annual Meeting of European Network of Official Medicines Control Laboratories (OMCL), Limassol, Cyprus, 9-12 May 2006 - EDQM as a WHO Collaborative Centre, 4 May 2006
EDQM designated as a WHO Collaborative Centre for ISA
- 2005
- 2005 Press Releases Archives
- PDG Meeting, 7-10 November 2005
Pharmacopoeial Discussion Group (PDG) meeting, Chicago, Illinois, USA, 7-10 November 2005 - Certification Conference, 27-28 October 2005
International Conference on Certification, Istanbul, Turkey, 27-28 October 2005 - New Observers August 2005
- OMCL Info Day 27 May 2005
1995-2005 10th anniversary: Official Control Laboratories of Medicines Information Day, 27 May 2005, Rome, Italy - Annual Meeting OMCL 23-26 May 2005
10th Annual Meeting of European Network of Official Medicines Control Laboratories (OMCL), Rome, Italy, 23-26 May 2005 - PDG Meeting 9-12 May 2005
Pharmacopoeial Discussion Group (PDG) meeting, Brussels, Belgium, 9-12 May 2005 - New building for the EDQM 28 April 2005
New building for the EDQM - a European centre for pharmaceutical excellence - Whole Cell Pertussis Vaccine 16 March 2005
Alternatives to Whole Cell Pertussis Vaccine Potency Assay, Geneva, Switzerland, 16 March 2005 - US FDA and PhEur Commission March 2005
The US Food and Drug Administration (FDA) is granted Observer status to the European Pharmacopoeia Commission - Quality of homoeopathic products 15 February 2005
Quality of homoeopathic products in the new European legislative framework, Strasbourg, 15 February 2005
- Press articles
- Quality Assurance Policy
- Library
- Demande de RDV Bibliothèque
Demande de RDV Bibliothèque - EDQM Library Access Form
EDQM Library Access Form (Word format)
- Demande de RDV Bibliothèque
- Visits
- DEQM Formulaire de Demande de Visite
DEQM Formulaire de Demande de Visite - EDQM Visit Request Form
EDQM Visit Request Form (Word format)
- DEQM Formulaire de Demande de Visite
- Job Opportunities
- HealthCare EDQM European Pharmacopoeia & PDG Certification OMCL Activities & Guidelines Publications, Products Events organised by the EDQM HelpDesk
- 1- General
- 2- Blood Transfusion
- General
- NEW: Pandemic Influenza - Planning for Blood Organisations
Consolidating the work of the European Blood Alliance Emergency Planning Action Group (EBA EPAG) (May 2009) - Mandat du Comité CD-P-TS
- Terms of reference CD-P-TS
- List of Members - CD-P-TS (23/11/09)
- List of Members - TS-GPUQA (23/11/09)
- General Information Blood Transfusion Activities (Eng/Fr, Feb 2009)
- Blood Transfusion Activities Factsheet (English, Jan 2009)
- Activités liées à la Transfusion Sanguine Factsheet (Francais, janvier 2009)
- NEW: Pandemic Influenza - Planning for Blood Organisations
- Recommendations
- Blood Transfusion Recommendations (Download all files, English)
- Explanatory Memorandum to the Recommendation Rec(2004)18
- Recommendation No (2004) 18 of the Committee of Ministers to member states on teaching transfusion medicine to nurses
- Recommendation No (2004) 8 of the Committee of Ministers to member states on autologous cord blood banks
- Explanatory Memorandum to the Recommendation Rec(2004)8
- Recommendation No (2003) 11 of the Committee of Ministers to member states on the introduction of pathogen inactivation procedures for blood components
- Recommendation No (2002) 11 of the Committee of Ministers to member states on the hospital’s and clinician’s role in the optimal use of blood and blood products
- Recommendation No (2001) 4 of the Committee of Ministers to member states on the prevention of the possible transmission of Creutzfeldt-Jakob Disease by blood transfusion
- Recommendation No R(98)10 on the use of human red blood cells for the preparation of oxygen-carrying substances
- Recommendation No R(98)2 of the Committee of Ministers to member states on provision of haematopoietic progenitor cells
- Recommendation No R(96)11 of the Committee of Ministers to member states on documentation and record-recording to guarantee the traceability of blood and blood products especially in hospital
- Recommendation No R(95)15 on the preparation, use and quality assurance of blood components.
- Recommendation No R(95)14 on the protection of the health of donors and recipients in the area of blood transfusion
- Recommendation No R(94)10 of the Committee of Ministers to member states on early pharmacological intervention against HIV infection
- Recommendation No R(93)4 of the Committee of Ministers to member states concerning clinical trials involving the use of components and fractionated products derived from human blood or plasma
- Recommendation No R(90)9 of the Committee of Ministers to member states on plasma products and European self-sufficiency
- Recommendation No R(90)3 of the Committee of Ministers to member states on medical research on human beings
- Recommendation No R(89)14 of the Committee of Ministers to member states on ethical issues of HIV infection in the health care and social settings
- Recommendation No R(88)4 on the responsibilities of health authorities in the field of blood transfusion
- Recommendation No R(87)25 of the Committee of Ministers to member states on common European public health policy to fight the acquired immunodeficiency syndrome (AIDS)
- Recommendation No R(86)6 of the Committee of Ministers to member states on guidelines for the preparation, quality control and use of fresh frozen plasma (FFP)
- Recommendation No R(85)12 of the Committee of Ministers to member states on the screening of blood donors for the presence of AIDS markers
- Recommendation No R(85)5 of the Committee of Ministers to member states on a model curriculum vitae for the training of specialists in blood transfusion
- Recommendation No R(84)16 concerning notification of work involving recombinent deoxyribonucleic (DNA)
- Recommendation No R(84)6 of the Committee of Ministers to member states on the prevention of the transmission of malaria by blood transfusion
- Recommendation No R(83)8 of the Committee of Ministers to member states on preventing the possible transmission of acquired immune deficiency syndrome (AIDS) from affected blood to patients receiving blood or blood products
- Recommendation No R(81)14 of the Committee of Ministers to member states on the assessment of the risks of transmitting infectious diseases by international transfer of blood, its components and derivatives
- Recommendation No R(81)5 of the Committee of Ministers to member states on antenatal administration of anti-D immunoglobulin
- Recommendation No R(80)5 of the Committee of Ministers to member states on blood products for the treatment of haemophiliacs
- Recommendation No R(79)5 of the Committee of Ministers to member states on the transport and international exchange of substances of human origin
- Reports
- Pathogen Reduction Technologies for Blood Components for Transfusion: Updated Table March 2008
- Reporting from Council of Europe member states on the collection, testing and use of blood and blood components in Europe : 2006 Survey
- Reporting from Council of Europe member states on the collection, testing and use of blood and blood components in Europe: The 2003 Survey
- NEW: 2004 Report on the Collection, testing and use of blood and blood components in Europe
- NOUVEAU: Rapport 2004 sur la collecte, la qualification et l’utilisation du sang et des composants sanguins en Europe
- 2003 Report on the collection, testing and use of blood and blood products in Europe
- 2002 Report on the collection, testing and use of blood and blood products in Europe
- 2001 Report on the Collection, testing and use of blood and blood products in Europe
- Resolutions
- Résolution CM/Res(2008)5 sur la responsabilité des donneurs et sur la limitation du don du sang et des composants sanguins
Adoptée par le Comité des Ministres le 12 mars 2008, lors de la 1021e réunion des Délégués des Ministres - Resolution CM/Res(2008)5 on donor responsibility and on limitation to donation of blood and blood components
Adopted by the Committee of Ministers on 12 March 2008 at the 1021st meeting of the Ministers’ Deputies - Resolution 68 (32) Establishment in Amsterdam of a European blood bank of rare groups
Adopted by the Ministers Deputies on 31 October 1968
- Résolution CM/Res(2008)5 sur la responsabilité des donneurs et sur la limitation du don du sang et des composants sanguins
- General
- 3- Organ Transplantation
- ALLIANCE-O ERANet Coordination Action
- Workshop Meeting Minutes, Paris, 24 Oct 2007
- White Paper 2004-2007
- Work Packages
- Download all 18 work packages
- Work Package 7: Ethical & Legal Aspects
D7.2 - Position Paper - Work Package 7: Ethical & Legal Aspects
D7.1 - Ethical and legal approaches overview - Work Package 6: Fundamental research linked to organ donation
D6.2 - Proposal of strategies to improve efficiency of fundamental research - Work Package 6: Fundamental research linked to organ donation
D6.1 - State of the Art Review - Work Package 5: Coordination of evaluation of methodologies of transplantation performance
D5.4 - Development of future collaboration - Work Package 5: Coordination of evaluation of methodologies of transplantation performance
D5.3 - Review of simulation tools for exploring the merits of different allocation procedures in terms of their impact on patient or graft survival - Work Package 5: Coordination of evaluation of methodologies of transplantation performance
D5.2 - Proposal for standardised methods to monitor the performance of different transplantation teams and standardised risk factors - Work Package 5: Coordination of evaluation of methodologies of transplantation performance
D5.1 - State of the art of evaluation methodologies - Work Package 4: Increase safety and quality of organ transplantation
D4.4 - Common best practices for organ transplantation quality systems - Work Package 4: Increase safety and quality of organ transplantation
D4.3 - State of the art of quality systems - Work Package 4: Increase safety and quality of organ transplantation
D4.2 - Elaboration of common guideline for organ safety - Work Package 4: Increase safety and quality of organ transplantation
D4.1 - State of the art of safety processes, exchange of best practices - Work Package 3: Organ allocation in Europe
D3.2 - Specification of a common simulation tool for organ allocation - Work Package 3: Organ allocation in Europe
D3.1 - Position paper on best practices for organ allocation in Europe - Work Package 2: Expanding Donor Pool
D2.5 - Proposal for common methods and indicators for donor pool estimation - Work Package 2: Expanding Donor Pool
D2.3 - Position paper on promotion of organ donation - Work Package 2: Expanding Donor Pool
D2.2 - Position paper for expanding the donor pool - Work Package 2: Expanding Donor Pool
D2.1 & D2.4 - State of the art in donor pool estimation
State of the art in expanding the donor pool
- General
- Terms of Reference CD-P-TO
- Lancet Commentary - Declaration of Istanbul
- List of Members - CD-P-TO (23/11/09)
- Mandat du Comité CD-P-TO
- Mandat CD-P-TO
- Conference Programme
New Challenges in Organ Donation: How can we improve? 6-7 November 2007, Madrid, Spain - 40 DONORS PMP PLAN, 23 October, Madrid
PLAN DONACIÓN CUARENTA, 23 de Octubre, Madrid (English & Spanish) - The Declaration of Istanbul
Participants in the International Summit on Transplant Tourism and Organ Trafficking convened by The Transplantation Society and International Society of Nephrology in Istanbul, Turkey, April 30–May 2, 2008 - Organ Transplantation Activities Factsheet (English, Sept 2008)
- General Information Organ Transplantation Activities (Eng/Fr, Oct 2008)
- DSO Press Release-English
- Recommendations
- Organ Transplantation Recommendations (Download all the files, English)
- Recommendation No (2006) 16 of the Committee of Ministers to member states on quality improvement programmes for organ donation
- Recommendation No (2006) 15 of the Committee of Ministers to member states on the background, functions and responsibilities of a National Transplant Organisation (NTO)
- Recommendation No (2005) 11 of the Committee of Ministers to member states on the role and training of professionals responsible
- Recommendation No (2004) 19 of the Committee of Ministers to member states on criteria for the authorisation of organ transplantation facilities
- Recommendation No (2004) 7 of the Committee of Ministers to member states on organ trafficking
- Recommendation No (2004) 8 of the Committee of Ministers to member states on autologous cord blood banks
- Recommendation No (2003) 12 of the Committee of Ministers to member states on organ donor registers
- Explanatory memorandum to Recommendation Rec(2003)10
- Recommendation No (2003) 10 of the Committee of Ministers to member states on xenotransplantation
- Recommendation No (2001) 5 of the Committee of Ministers to member states on the management of organ transplant waiting lists
- Recommendation No (97) 16 of the Committee of Ministers to member states on liver transplantation from living related donors
- Recommendation No (97) 15 of the Committee of Ministers to member states on xenotransplantation
- Recommendation No (94) 1 of the Committee of Ministers to member states on human tissue banks
- Reports
- Resolutions
- Resolution CM/Res(2008)6 on transplantation of kidneys from living donors who are not genetically related to the recipient
Adopted by the Committee of Ministers on 26 March 2008 at the 1022nd meeting of the Ministers’ Deputies - Résolution CM/Res(2008)6 sur la transplantation de rein de donneurs vivants qui ne sont pas génétiquement liés au receveur
Adoptée par le Comité de Ministres le 26 mars 2008, lors de la 1022e réunion des Délégués des Ministres - Resolution CM/Res(2008)4 on adult-to-adult living donor liver transplantation
Adopted by the Committee of Ministers on 12 March 2008 at the 1021st meeting of the Ministers Deputies - Résolution CM/Res(2008)4 sur la transplantation de foie de donneurs vivants entre adultes
Adoptée par le Comité de Ministres le 12 mars 2008, lors de la 1021e réunion des Délégués des Ministres - Resolution CM/Res(78) 29 on harmonisation of legislations of member states relating to removal, grafting and transplantation of human substances
Adopted by the Committee of Ministers on 11 May 1978 at the 287th meeting of the Ministers\' Deputies - Résolution CM/Res(78) 29 sur l\'harmonisation des législations des Etats membres relatives aux prélèvements, greffes et transplantations de substances d\'origine humaine
Adoptée par le Comité des Ministres le 11 mai 1978,
lors de la 287e réunion des Délégués des Ministres
- Resolution CM/Res(2008)6 on transplantation of kidneys from living donors who are not genetically related to the recipient
- Publications
- ALLIANCE-O ERANet Coordination Action
- 4- Pharmaceutical & Pharmaceutical Care
- General
- 1032 Réunion, 9 juillet 2008
Projet de mandat PH/PC/PHO/CMED - 1032 Meeting, 9 July 2008
Draft terms of reference of the PH/PC/PHO/CMED - Mandat révisé du Comité CD-P-PH
1017e Réunion 06/02/2008 - Revised terms of reference of the European Committee CD-P-PH
1017th Meeting 06/02/2008
- 1032 Réunion, 9 juillet 2008
- Meeting Reports CD-P-PH
- General
- 5- Counterfeit Medicines
- General
- Notification de contrefaçon de medicament
- Counterfeit Medicinal Product Notification Form
- Déclaration de Moscou
Conférence internationale : L\'Europe contre les médicaments contrefaits, 23-24 octobre 2006 - Moscow Declaration
International Conference - Europe against Counterfeit Medicines, 23-24 October 2006 - Un modele de reseau et de points de contact uniques (PCU)
Groupe ad hoc sur les médicaments contrefaits (P-SP-PH/CMED) - Model for a Network and Single Points of Contacts (SPOCs)
Ad hoc Group on Counterfeit Medicines (P-SP-PH/CMED) - Risk communication model
- Reports
- Resolutions
- General
- 6- Classification of Medicines
- General
- Resolutions
- Resolution ResAP(2007)2 English
Good practices for distributing medicines via mail order - Resolution ResAP(2007)2 French
Bonnes pratiques en matière de distribution des médicaments par correspondance - Resolution AP(2007) 1 English
(superseding Resolution ResAP(2000)1 on the classification of medicines which are obtainable only on medical prescription) and Appendices (2008 Edition) - Resolution AP (2007)1 French
(remplaçant la Résolution ResAP(2000)1 relative à la classification des médicaments dont la délivrance est soumise à ordonnance) et Annexes I, II & III
Edition 2008 - Resolution ResAP (2001)2 English
Pharmacists role in the framework of health security - Resolution ResAP (2001) 2 French
Role du pharmacien dans le cadre de la sécurité sanitaire - Resolution AP (2000) 1 English
on the Classification of medicines which are obtainable only on medical prescription, and Appendices (2006 Edition) - Resolution AP (2000) 1 English
on the Classification of medicines which are obtainable only on medical prescription, and Appendices (2005 Edition) - Resolution AP (2000) 1 English
on the Classification of medicines which are obtainable only on medical prescription, and Appendices (2004 Edition)
- Resolution ResAP(2007)2 English
- 7- Quality and safety standards in pharmaceutical
- Council of Europe model campaign
- Proceedings: Expert Meeting on Medication Safety, 21-22 November, The Hague
- Report 2006
Creation of a better medication safety culture in Europe: Building up safe medication practices, Expert Group on Safe Medication Practices (P-SP-PH/SAFE) - Medicines and the Internet
- Core message of user-oriented guidance (German)
- Core message of user-oriented guidance (Spanish)
- Vente et publicite des medicaments sur internet
Préparé par le Comité d’Experts des Questions Pharmaceutiques, le 13 novembre 2002 - Selling and advertising of medicines on the internet
Prepared by the Committee of Experts on Pharmaceutical Questions, 13 November 2002 - Workshop report - Medicines on the web:risks and benefits
UN Internet Governance Forum (IGF), Sharm El Sheik, 15-18 November 2009
- European Pharmacopoeia & PDG EDQM HealthCare Certification OMCL Activities & Guidelines Publications, Products Events organised by the EDQM HelpDesk
- European Pharmacopoeia
- NEW: Circular Letter Resolution AP-CPH (09) 4 (English)
- NOUVEAU: Lettre Circulaire Résolution AP-CPH (09) 4 (French)
- NMR test protocol for OSCS determination in API Heparin Sodium and Calcium
- Heparin: a new capillary electrophoresis method
- Héparine: une méthode électrophorèse capillaire
- Heparin sodium monograph (Published in Pharmeuropa 22.1)
- Heparin calcium monograph (Published Pharmeuropa 22.1)
- Resolution AP-CPH (08) 5 European Committee on Pharmaceuticals & Pharmaceutical Care
Adopted by the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) (Partial Agreement) on 18 July 2008 - Résolution AP-CPH (08) 5 Comité européen sur les produits et les soins pharmaceutiques
Adoptée par le Comité européen sur les produits et les soins pharmaceutiques (CD-P-PH) (Accord Partiel) le 18 juillet 2008 - Pharmeuropa 21.4 Draft monographs
- Pharmeuropa 22.1 Draft monographs
- PhEur Commission Decisions
- 2010
- 2009
- Decisions Ph Eur Comm 122009 (English)
- Decisions Ph Eur Comm 062009
- List of texts adopted at PhEur Commission June 2009
- Liste des textes adoptes Commission PhEur, juin 2009
- Decisions Ph Eur Comm 032009
- List of texts adopted at PhEur Commission March 2009
- Liste des textes adoptes Commission PhEur, Mars 2009
- 2008
- Decisions Ph Eur Comm 112008 (English)
- Décisions Ph Eur Comm 112008 (Français)
- Decisions Ph Eur Comm 062008 (English)
List of new or revised texts adopted by the PhEur Commission, June 2008 session - Décisions Ph Eur Comm 062008 (Francais)
Liste des textes adoptés à la session de juin 2008 de la Commission Européenne de Pharmacopée - Decisions Ph Eur Comm 032008 (English)
List of new or revised texts adopted by the PhEur Commission, March 2008 session - Décisions Ph Eur Comm 032008 (Francais)
Liste des textes adoptés à la session de novembre 2007 de la Commission Européenne de Pharmacopée
- 2007
- Decisions Ph Eur Comm 112007 (English)
List of new or revised texts adopted by the PhEur Commission, June 2007 session - Décisions Ph Eur Comm 112007 (Francais)
Liste des textes adoptés à la session de novembre 2007 de la Commission Européenne de Pharmacopée - Decisions Ph Eur Comm 062007
List of new or revised texts adopted by the PhEur Commission, June 2007 session - Decisions Ph Eur Comm 032007
List of new or revised texts adopted by the PhEur Commission, March 2007 session
- Decisions Ph Eur Comm 112007 (English)
- 2006
- Decisions Ph Eur Comm 112006
List of new or revised texts adopted by the PhEur Commission, November 2006 session - Decisions Ph Eur Comm 062006
List of new or revised texts adopted by the PhEur Commission, June 2006 session - Decisions Ph Eur Comm 032006
List of new or revised texts adopted by the PhEur Commission, March 2006 session
- Decisions Ph Eur Comm 112006
- 2005
- Decisions Ph Eur Com 062005
List of new or revised texts adopted by the PhEur Commission, June 2005 session - Decisions Ph Eur Com 112005
Decisions of the European Pharmacopoeia Commission, November 2005 (texts and CRS/BRP adopted and revisions of monographs and general texts) - Decisions Ph Eur Com 032005
Decisions of the European Pharmacopoeia Commission, March 2005 (texts and CRS/BRP adopted and revisions of monographs and general texts)
- Decisions Ph Eur Com 062005
- 2004
- Decisions Ph Eur Com 062004
Decisions of the European Pharmacopoeia Commission, June 2004 (texts and CRS/BRP adopted and revision of monographs and general texts). - Decisions Ph Eur Com 112004
Decisions of the European Pharmacopoeia Commission, November 2004 (texts and CRS/BRP adopted and revisions of monographs and general texts).
- Decisions Ph Eur Com 062004
- 2003
- Decisions Ph Eur Com 112003
Decisions of the European Pharmacopoeia Commission, November 2003 (texts and CRS/BRP adopted and revision of monographs and general texts).
- Decisions Ph Eur Com 112003
- Work Programme
- 2010
- 2009
- 2008
- Modification Work Programme 112008
- Mise à jour programme de travail 112008
- Mise à jour Programme de travail 062008
Mise à jour du programme de travail de la Pharmacopée Européenne (Décisions de la Commission Européenne de Pharmacopée, juin 2008) - Modification Work Programme 062008
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the PhEur Commission, June 2008) - Mise à jour Programme de travail 032008
Mise à jour du programme de travail de la Pharmacopée Européenne (Décisions de la Commission Européenne de Pharmacopée, mars 2008) - Modification Work Programme 032008
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the PhEur Commission, March 2008)
- 2007
- Mise à jour Programme de travail 112007
Mise à jour du programme de travail de la Pharmacopée Européenne (Décisions de la Commission Européenne de Pharmacopée, novembre 2007) - Modification Work Programme 112007
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the PhEur Commission, November 2007) - Modifications Work Programme 062007
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the PhEur Commission, June 2007) - Modifications Work Programme 0307
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the PhEur Commission, March 2007)
- Mise à jour Programme de travail 112007
- 2006
- Modification Work Programme 1106
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the PhEur Commission, November 2006) - Modification Work Programme 0606
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the PhEur Commission, June 2006) - Modification Work Programme 0306
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the PhEur Commission, March 2006)
- Modification Work Programme 1106
- 2005
- Modification Work Programme 1105
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the PhEur Commission, November 2005) - Modification Work Programme 0605
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the European Pharmacopoeia Commission, June 2005) - Modification Work Programme 0305
Modification of the Work Programme of the European Pharmacopoeia Commission (Decisions of the European Pharmacopoeia Commission, March 2005)
- Modification Work Programme 1105
- 2004
- Modification Work Programme 1104
Modification of the Work Programme of the PhEur Commission (Decision of the European Pharmacopoeia Commission, November 2004). - Modification Work Programme 0604
Modification of the Work Programme of the PhEur Commission (Decisions of European Pharmacopoeia Commission, June 2004) - Modification Work Programme 0304
Modification of the Work programme of the PhEur Commission (Decisions of European Pharmacopoeia Commission, March 2004)
- Modification Work Programme 1104
- 2003
- Modification Work Programme 1103
Modification of the Work programme of the PhEur Commission (Decisions of European Pharmacopoeia Commission November 2003)
- Modification Work Programme 0603
Modification of the Work programme of the PhEur Commission (Decisions of European Pharmacopoeia Commission, June 2003).
- Modification Work Programme 1103
- Biological Standardisation Programme
- General
- Potentialy genotoxic impurities & PhEur monographs
General Information, Pharmeuropa 20.3, July 2008 - Impuretés potentiellement génotoxiques & monographies
Information générale, Pharmeuropa 20.3, juillet 2008 - Policy Paper: Potentially genotoxic impurities, March 2008
PA/PH/SG (07) 52 COM 1R (English & French) - Procedure 4 Workflow
- Procédure 4 Processus
- Rules of Procedure Ph Eur Com
- Règlement intérieur de la Commission Pheur
- Procedure 1 Workflow
- Procédure 1 Processus
- List of codes of experts & groups
- PA/PH/SG (00) 66 DEF Guide for the work of the European Pharmacopoeia
- PA/PH/SG (00) 66, DEF Guide relatif aux travaux de la Pharmacopée européenne
- 1994 Protocol PhEur (English)
- 1994 Protocole PhEur (Français)
- 1964 PhEur Convention (English)
- 1964 Convention Ph Eur (Français)
- Biographical Notes
Biographical Notes - Mrs Marianne Ek & Dr Gerard Lee
- Potentialy genotoxic impurities & PhEur monographs
- Pharmacopoeial Discussion Group (PDG)
- PDG State of Work
State of Work on International Harmonisation (October 2009) - GDP État des travaux
État des travaux de l\'harmonisation internationale (octobre 2009) - Projected Timetable PDG
Projected timetable for publication & implementation of texts (October 2009) - GDP Calendrier prévisionnel
Calendrier Prévisionnel pour la publication et la mise en application des textes (juin 2009) - PDG Working Procedures
PDG Working Procedures (signed off document Nov. 2007) English only - PDG Statement IH Policy
PDG Statement of International Harmonisation Policy (July 2004) - GDP Énoncé de la politique d\'HI
Énoncé de la politique d\'harmonisation (juillet 2004)
- PDG State of Work
- European Pharmacopoeia
- Certification EDQM HealthCare European Pharmacopoeia & PDG OMCL Activities & Guidelines Publications, Products Events organised by the EDQM HelpDesk
- Procedure of Certification
- NEW: PA/PH/CEP (04) 2, 4R Guideline on revision/renewal of certificates of suitability to the monographs of the European Pharmacopoeia
- NEW: PA/PH/Exp. CEP/T (04) 18, 2R Procedures for management of revisions/renewals of certificates of suitability to the monographs of the European Pharmacopoeia
- NEW: PA/PH/CEP (09) 141 New procedure for the assessment of “sister files”
- NEW - PA/PH/CEP (09) 108 Submission of electronic applications for Certificates of Suitability (CEPs): Revised procedures
- NEW: PA/PH/CEP (09) 109 Explanatory note: revised EDQM procedures related to submissions for CEP applications
- PA/PH/CEP (08) 17, R1 Suspension or cancellation of a CEP
- PA/PH/CEP (08) 60 Clarification on the acceptability of CEP applications for sterile grade material
- PA/PH/CEP (08) 60 Clarification on the acceptability of CEP applications for sterile grade material
欧洲药典适应性证书 : 无菌级CEP证书申请受理说明 (English/Chinese) - PA/PH/Exp. CEP/T (08) 37 Note for the applicants: Procedure for validation of new applications
- PA/PH/Exp. CEP/T (08) 37 Note for the applicants: Procedure for validation of new applications
申请人须知：新CEP申请验收程序 (English/Chinese) - PA/PH/Exp. CEP/T (08) 37 Note aux demandeurs : Procédure de validation des nouvelles demandes
- Explanatory Note on the Revised Version of the Resolution AP-CSP (07)1 (Chinese)
- PA/PH/CEP (04) 2 3R: Guideline on Requirements for Revisions/Renewals of Certificates
- AP-CSP (07) 1 E: Certification Procedure Revised Version
- AP-CSP (07) 1: Certification Procedure Revised Version (Chinese)
- PA/PH/CEP (04) 2, 3R Guide relatif aux exigences applicables en matière de révision/renouvellement des certificats de conformité aux monographies de la Pharmacopée européenne
- PA/PH/CEP(04) 2, 3R Guideline on Requirements for Revision/Renewal of Certificates, May 2008
注意：该文件最近进行了修订（详情见英文文本）。中文文本将尽快发布。 - PA/PH/Exp CEP/T (04) 18 1R Procedure for Management of Revisions/Renewals of Certificates
- PA/PH/Exp. CEP/T (04) 18, 1R Procédures de traitement des demandes de révision/renouvellement de certificats de conformité aux monographies de la Pnarmacopée européenne
- PA/PH/Exp. CEP/T (04)18 1R New Procedures for management of revisions/renewals of certificates, June 2008
注意：该文件最近进行了修订（详情见英文文本）。中文文本将尽快发布。(English/Chinese) - PAPHExpCEPT0426: Revision of TSE Certificates for the 5th Edition of the European Pharmacopoeia (15/11/04)
- Renewal of Certificates of Suitability - Implementation of the Amendments to the Directives 2001/83/EC and 2001/82/EC (Revised 03/01/06)
- Policy on stating manufacturing sites on CEPs
- Application Forms and QOS Template
- Content of Dossier
- Chemical purity & microbiological quality
- Content of the Dossier for Chemical Purity & Microbiological Quality
- PA/PH/CEP (08) 11 Top deficiencies found in Applications
From October to December 2007 (Published Sept 2008) - PA/PH/CEP (08) 11 Deficiences principalement observees
D\'octobre 2007 à décembre 2007 (septembre 2007) - Content of the Dossier for chemical purity and microbiological quality
PA/PH/CEP 04 1 4R: 欧洲药典适用性证书: 化学合成和有微生物品质要求品种的文件内容
- Herbals products
- Sterile active substances
- Substance for TSE risk assessment
- Chemical purity & microbiological quality
- List of assessors
- General
- Notice to holders of CEPs for heparin or enoxaparin
- Avis aux détenteurs de CEP pour héparine énoxaparine
- How to order CEPs
- PA/PH/CEP (01) 1 8R Terms of Reference for Certification of Suitability, December 2008
- Implementation of the European Pharmacopoeia supplement 6.3
- Implementation of the European Pharmacopoeia supplement 6.4
- Implementation of the European Pharmacopoeia supplement 6.5
- Registration fees
- Inspections
- Technical advice
- Samples
- Procedure of Certification
- OMCL Activities & Guidelines EDQM HealthCare European Pharmacopoeia & PDG Certification Publications, Products Events organised by the EDQM HelpDesk
- OMCL Activities
- NEW: PA/PH/OMCL (09) 45 4R CORR - Annex 3 to the GEON Terms of Reference: List of GEON Members
- NEW: Radiopharmaceutical PTS Registration Form 2010
- NEW:Physico-Chemical PTS Registration Form 2010
- NEW: PTS Biological Registration Form 2010
- Radiopharmaceutical PTS Registration Form 2009
- Physico-Chemical PTS Registration Form 2009
- PTS Biological Registration Form 2009
- CAP Operational Procedure (PA/PH/CAP (05) 49 R)
General procedure for sampling and testing of centrally-authorised products (Adopted 09/12/2005) - MRP/DCP Post-Marketing Surveillance
Co-operation in post-marketing surveillance of Mutual Recognition/Decentralised Procedure Products (PA/PH/OMCL 06 116 7R, November 2009) - PA/PH/OMCL (07) 79 12Rcorr - Terms of Reference for the General European OMCL Network (GEON) of the Council of Europe
- PA/PH/OMCL (07) 89 8R - Annex 1 to the GEON Terms of Reference: Definition of an OMCL and OMCL Status within the GEON
- PA/PH/OMCL (07) 90 4R - Annex 2 to the GEON Terms of Reference: Factors for determining OMCL status within the GEON
- Human Biologicals (OCABR)
- Guidelines
- Administrative procedures
- Annex III 1/03/10
Annex III: Human OCABR contact list (last updated 1/03/10) - Procedure for OCABR of Centrally Authorised Immunological products & products derived from human blood & plasma
Procedure for OCABR of Centrally Authorised immunological medicinal products and products derived from human blood and plasma (2009) - EC Administrative Procedure for Official Control Authority Batch Release 2009 REVISED
EC Administrative Procedure for Official Control Authority Batch Release (2009) (Entry into force: 1 January 2010)
- Annex III 1/03/10
- Guidelines for blood products
- Clotting Factor Concentrates, Plasma Inhibitor Concentrates and Fibrin Sealants
Clotting Factor Concentrates, Plasma Inhibitor Concentrates & Fibrin Sealants (2009) - Human Albumin
Human albumin (2009) - Human Immunoglobulin
Human immunoglobulin (2009) - Human Plasma (pooled & treated for virus inactivation) Formerly Solvent-Detergent (SD) Plasma
Human Plasma (pooled & treated for virus inactivation) (2009) - Official Control Authority Protocol for Approval of Plasma Pools
Official Control Authority Protocol for Approval of Plasma Pools (2009) - Validation of Nucleic Acid Amplification Techniques (NAT) for Quantitation of B19 Virus DNA in Plasma Pools
Validation of Nucleic Acid Amplification Techniques (NAT) for Quantitation of B19 Virus DNA in Plasma Pools (2009)
- Clotting Factor Concentrates, Plasma Inhibitor Concentrates and Fibrin Sealants
- Guidelines for vaccines
- BCG vaccine
BCG Vaccine (2009) - Cell Cultured Influenza Vaccine (Surface Antigen, Inactivated) REVISED
Cell Cultured Influenza Vaccine (Surface Antigen, Inactivated) (2009) - Cholera Vaccine (Oral, Inactivated)
Cholera Vaccine (Oral, Inactivated) (2009) - Diphtheria and Tetanus Vaccine (Absorbed)
Diphtheria and Tetanus Vaccine (adsorbed) (2009) - Diphtheria, Tetanus and Hepatitis B (rDNA) Combined Vaccine (Adsorbed)
Diphtheria, Tetanus and Hepatitis B (rDNA) Combined Vaccine (Adsorbed) (2009) - Diphtheria, Tetanus and Pertussis (Whole Cell) Combined vaccine (Adsorbed) REVISED
Diphtheria, Tetanus and Pertussis (Whole Cell) Combined Vaccine (Adsorbed) (2009) - Diphtheria, Tetanus and Pertussis (Acellular Component) Combined Vaccine (adsorbed)
Diphtheria, Tetanus and Pertussis (Acellular Component) Combined Vaccine (Adsorbed) (2009) - Diphtheria, Tetanus, Pertussis (Acellular Component) and Haemophilus Type B Conjugate Combined vaccine (Adsorbed)
Diphtheria, Tetanus, Pertussis (Acellular Component) and Haemophilus Type B Conjugate Combined Vaccine (Adsorbed) (2009) - Diphtheria, Tetanus, Pertussis (Acellular Component) and Hepatitis B (rDNA) Combined vaccine (Adsorbed)
Diphtheria, Tetanus, Pertussis (Acellular Component) and Hepatitis B (rDNA) Combined Vaccine (Adsorbed) (2009) - Diphtheria, Tetanus, Pertussis (Whole Cell) and Poliomyelitis (Inactivated) Combined vaccine (adsorbed)
Diphtheria, Tetanus, Pertussis (Whole Cell) and Poliomyelitis (Inactivated) Combined Vaccine (Adsorbed) (2009) - Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated) Combined vaccine (Adsorbed)
Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated) Combined Vaccine (Adsorbed) (2009) - Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated) and Haemophilus Type B Conjugate Combined vaccine (Adsorbed)
Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated) and Haemophilus Type B Conjugate Combined Vaccine (Adsorbed) (2009) - Diphtheria, Tetanus, Pertussis (Whole Cell), Poliomyelitis (Inactivated) and Haemophilus Type B Conjugate Combined vaccine (Adsorbed)
Diphtheria, Tetanus, Pertussis (Whole Cell), Poliomyelitis (Inactivated) and Haemophilus Type B Conjugate Combined Vaccine (Adsorbed) (2009) - Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated), Hepatitis B (rDNA) and Haemophilus Type B Conjugate Combined vaccine (Absorbed)
Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated), Hepatitis B (rDNA) and Haemophilus Type B Conjugate Combined Vaccine (Absorbed) (2009) - Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated), Hepatitis B (rDNA) with separate Haemophilus Type B Conjugate Combined vaccine (Absorbed)
Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated), Hepatitis B (rDNA) with separate Haemophilus Type B Conjugate Combined Vaccine (Absorbed) (2009) - Diphtheria, Tetanus and Poliomyelitis (Inactivated) Combined vaccine (adsorbed)
Diphtheria, Tetanus and Poliomyelitis (Inactivated) Combined Vaccine (Adsorbed) (2009) - Haemophilus Type B Conjugate vaccine
Haemophilus Type B Conjugate Vaccine (2009) - Haemophilus Type B Conjugate and Hepatitis B (rDNA) Combined vaccine
Haemophilus Type B Conjugate and Hepatitis B (rDNA) Combined Vaccine (2009) - Hepatitis A Vaccine (Inactivated, absorbed)
Hepatitis A Vaccine (Inactivated, Absorbed) (2009) - Hepatitis A (Virosomal) vaccine
Hepatitis A (Virosomal) Vaccine (2009) - Hepatitis A (Inactivated) and Hepatitis B (rDNA) Combined vaccine (Absorbed)
Hepatitis A (Inactivated) and Hepatitis B (rDNA) Combined Vaccine (Absorbed) (2009) - Hepatitis A (Inactivated) and Typhoid Polysaccharide Combined vaccine (Adsorbed)
Hepatitis A (Inactivated) and Typhoid Polysaccharide Combined Vaccine (Adsorbed) (2009) - Hepatitis A (Inactivated) and Typhoid Polysaccharide Combined vaccine (Absorbed) for Mix-At-Use Format Products
Hepatitis A (Inactivated) and Typhoid Polysaccharide Combined Vaccine (Absorbed for Mix-At-Use Format Products) (2009) - Hepatitis B (rDNA) vaccine
Hepatitis B (rDNA) Vaccine (2009) - Human Papillomavirus (rDNA) vaccine
Human Papillomavirus (rDNA) Vaccine (2009) - Influenza vaccine REVISED
Influenza Vaccine (2009) - Influenza Vaccine (Surface Antigen, Inactivated, virosome) REVISED
Influenza Vaccine (Surface Antigen, Inactivated, virosome) (2009) - Japanese Encephalitis (JE) Vaccine, Inactivated NEW
Japanese Encephalitis (JE) Vaccine, Inactivated (2009) - Measles Vaccine
Measles Vaccine (2009) - Measles, Mumps, and/or Rubella Component Combined vaccine
Measles, Mumps, and/or Rubella Component Combined Vaccine (2009) - Measles, Mumps, Rubella & Varicella Combined vaccine
Measles, Mumps, Rubella and Varicella Combined Vaccine (2009) - Meningococcal C Polysaccharide Protein Conjugate Vaccine
Meningococcal C Polysaccharide Protein Conjugate Vaccine (2009) - Meningococcal Polysaccharide vaccine
Meningococcal Polysaccharide Vaccine (2009) - Multivalent Pneumococcal Polysaccharide Conjugate vaccine REVISED
Multivalent Pneumococcal Polysaccharide Conjugate Vaccine (2009) - Mumps vaccine
Mumps Vaccine (2009) - Pandemic Influenza Vaccine REVISED
Pandemic Influenza Vaccine (2009) - Pertussis Vaccine (Acellular Component, Adsorbed)
Pertussis Vaccine (Acellular Component, Adsorbed) (2009) - Pneumococcal Polysaccharide vaccine
Pneumococcal Polysaccharide Vaccine (2009) - Poliomyelitis Vaccine (Inactivated)
Poliomyelitis Vaccine (Inactivated) (2009) - Poliomyelitis Vaccine (Oral) (OPV) - Monovalent bulk
Poliomyelitis Vaccine (Oral) (OPV) - Monovalent Bulk (2009) - Poliomyelitis Vaccine (Oral) (OPV) - Trivalent vaccine
Poliomyelitis Vaccine (Oral) (OPV) - Trivalent Vaccine (2009) - Rabies Vaccine
Rabies Vaccine (2009) - Rotavirus vaccine
Rotavirus Vaccine (2009) - Rubella vaccine
Rubella Vaccine (2009) - Tick-Borne Encephalitis (TBE) vaccine
Tick-Borne Encephalitis (TBE) Vaccine (2009) - Typhoid vaccine (Live-Strain type 21a Oral)
Typhoid Vaccine (Live-Strain type 21a Oral) (2009) - Typhoid Polysaccharide vaccine
Typhoid Polysaccharide Vaccine (2009) - Vaccine containing Vaccinia Virus produced in cell culture (Smallpox vaccine)
Vaccine containing Vaccinia Virus produced in cell culture (Smallpox Vaccine) (2009) - Varicella Vaccine & Shingles vaccine
Varicella Vaccine & Shingles Vaccine (2009) - Yellow Fever vaccine
Yellow Fever Vaccine (2009)
- BCG vaccine
- Other related procedures
- Administrative Procedure for European OMCL Certification of Compliance of Batches under Article 58 REVISED
Administrative Procedure for European OMCL Certification of Compliance of Batches under Article 58 (2009)
- Administrative Procedure for European OMCL Certification of Compliance of Batches under Article 58 REVISED
- OCABR Human Biologicals Decision Flowchart
- OCABR Human Biologicals Flowchart
OCABR Human Biologicals Flowchart (revised December 2004)
- OCABR Human Biologicals Flowchart
- Veterinary Biologicals (OCABR/OBPR)
- OCABR Procedure Preface & Note to Users - Veterinary
- Procedures
- Procedure-Article 82
Procedure for Application of Article 82 (updated 22/06/07) - Procedure-Article 81
Procedure for Application for Article 81 (updated 22/06/07) - Annex IV 200110
Annex IV of Procedures for Article 81 and 82 - Contact list of CA/OMCLs for IVMPs (Last updated 20/01/2010)
- Procedure-Article 82
- Model Protocols for Manufacturers
- Product Specific Technical Guidelines
- Tuberculin PPD, Bovine
- Aujeszky\'s Disease Vaccine (live)
- Brucellosis Vaccine (live)
- Brucellin Preparations
- Equine Influenza Vaccine (inactivated)
- Infectious Bovine Rhinotracheitis Vaccine (inactivated)
- Infectious Bovine Rhinotracheitis Vaccine (live)
- Newcastle Disease Vaccine (inactivated)
- Newcastle Disease Vaccine (live)
- Rabies Vaccine (inactivated) for veterinary use
- Rabies Vaccine for Foxes (live)
- Swine Erysipelas Vaccine (inactivated)
- Swine Erysipelas Vaccine (live)
- Tuberculin PPD, Avian
- Aujeszky\'s Disease Vaccine (inactivated)
- IVMP Decision Flowchart
- IVMP_Flowchart
Decision Flowchart for CA for the Control of IVMPs
- IVMP_Flowchart
- Quality Assurance for the OMCL Network
- Documents
- NEW: Validation of Computerised Systems - Core Document
PA/PH/OMCL (08) 69 3R (July 2009) - NEW: Annex 1: Validation of computerised calculation systems: example of validation of in-house software
PA/PH/OMCL (08) 87 2R Validation of Computerised Systems (July 2009) - NEW: Annex 2: Validation of Databases (DB), Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN)
PA/PH/OMCL (08) 88 R Validation of Computerised Systems (July 2009) - NEW: Annex 3: Validation of computers as part of test equipment
PA/PH/OMCL (08) 89 R Validation of Computerised Systems (July 2009) - Annex 5 Qualification of Automatic Titrators
PA/PH/OMCL (07) 108 3R Qualification of equipment (August 2008) - Validation of Analytical Procedures
PA/PH/OMCL (05) 47 DEF (June 2005) - Uncertainty of Measurements - Part I (Compliance testing)
PA/PA/OMCL (05) 49 DEF CORR (December 2007) - Uncertainty of Measurements - Part II (Other than compliance testing)
PA/PH/OMCL (07) 106 DEF (December 2007) - Standard \'Aide-Mémoire\' for the Mutual Joint Audit of OMCLs
PA/PA/OMCL (06) 72 (EDIV/04) (July 2006) - Evaluation & Reporting of Results
PA/PH/OMCL (07) 28 DEF CORR (December 2007) - Qualification of Equipment (core document)
PA/PH/OMCL (08) 73 (September 2008) - Annex 1: Qualification of HPLC Equipment
PH/PA/OMCL (07) 17 DEF (February2007) - Annex 2: Qualification of GC equipment
PA/PH/OMCL (06) 86 DEF (October 2006) - \'Aide-Memoire\' for environmental conditions & treatment of biological models
PA/PH/OMCL (07) 75 (EDIV/14) (January 2007) - Annex 3: Qualification of UV-Visible spectrophotometers
PA/PH/OMCL (07) 11 DEF CORR (December 2007) - Annex 4: Qualification of IR spectrophotometers
PA/PH/OMCL (07) 12 DEF CORR (December 2007) - Scope of Accreditation
PA/PA OMCL (05) 48 DEF CORR (December 2007) - Archiving within the OMCL Network
PA/PH/OMCL (07) 105 DEF (April 2001)
- NEW: Validation of Computerised Systems - Core Document
- Documents
- OMCL Activities
- Publications, Products EDQM HealthCare European Pharmacopoeia & PDG Certification OMCL Activities & Guidelines Events organised by the EDQM HelpDesk
- Publications Catalogue
- How to order EDQM Publications
- How do I use the EDQM Online Store?
- Dispatch & Delivery - EDQM Publications
- How do I pay EDQM invoices?
- Products & Services Catalogue 2009 (English/French)
- Products & Services Catalogue 2008 (English/Spanish)
Catálogo de productos y servicios 2009 (inglés/español) - Products & Services Catalogue 2008 (English/Chinese)
产品和服务目录 2008（英文/中文） - How do I complain to the EDQM about an order?
- Distributors List India (January 2010)
- How to order Proficiency Testing Studies
- Comment commander une publication de la DEQM
- Commande d\'étalons de référence
- Comment adresser une réclamation au sujet d\'une commande de la DEQM ?
- Conditions et modalités de paiement de nos factures
- 7th Edition
- 6th Edition
- List of Converted Monographs
A list of converted monographs for the 6th Edition - How to Read a Monograph
- 6th Edition Supplement 6.8
- 6th Edition Supplement 6.7
- 6th Edition Supplement 6.6
- 6th Edition Supplement 6.5
- 6th Edition Supplement 6.4
- 6th Edition Supplement 6.3
- 6th Edition Supplement 6.2
- 6th Edition Supplement 6.1
- 6th Edition initial volumes 6.0
- 6th Edition implementation dates and texts deleted
- 6th Edition Implementation Dates: AP-CSP (06) 04
- AP-CPH (07) 3 Supplement 6.1 Date of implementation
- AP-CPH (07) 3 Supplement 6.1 Mise en application
- AP-CPH (07) 4 Supplement 6.2 Date of implementation
- AP-CPH (07) 4 Supplement 6.2 Mise en application
- AP-CPH (07) 5 Supplement 6.3 Mise en application
- AP-CPH (07) 5 Supplement 6.3 Date of implementation
- AP-CPH (08) 1 Supplement 6.4 Date of implementation
- AP-CPH (08) 1 Supplement 6.4 Mise en application
- AP-CPH (08) 2 Supplement 6.5 Date of implementation
- AP-CPH (08) 2 Supplement 6.5 Mise en application
- AP-CPH (08) 3 Supplement 6.6 Date of implementation
- AP-CPH (08) 3 Supplement 6.6 Mise en application
- AP-CPH (09) 1 Supplement 6.7 Date of implementation
- AP-CPH (09) 1 Supplement 6.7 Mise en application
- AP-CPH (09) 2 Supplement 6.8 Date of implementation
- AP-CPH (09) 2 Supplement 6.8 Mise en application
- List of Converted Monographs
- 5th Edition
- 5th Edition Supplement 5.8
- E Comments Supplement 5.8
Comments concerning some revised/corrected texts published in Supplement 5.8 - E Contents List 5.8
English List of Contents Supplement 5.8 - F Contents List 5.8
French List of Contents Supplement 5.8 - E Index 5th 5.8
English Cumulative Index 5th Edition 5.8 - F Index 5th 5.8
French Cumulative Index 5th Edition 5.8
- E Comments Supplement 5.8
- 5th Edition Supplement 5.7
- E Comments Supplement 5.7
Comments concerning some revised/corrected texts published in Supplement 5.7 - E Index 5th 5.7
English Cumulative Index 5th Edition 5.7 - F Index 5th 5.7
French Cumulative Index 5th Edition 5.7 - E Contents List 5.7
English List of Contents Supplement 5.7 - F Contents List 5.7
French List of Contents Supplement 5.7
- E Comments Supplement 5.7
- 5th Edition Supplement 5.6
- E Comments Supplement 5.6
Comments concerning some revised/corrected texts published in Supplement 5.6 - E Index 5th 5.6
English Cumulative Index 5th Edition 5.6 - F Index 5th 5.6
French Cumulative Index 5th Edition 5.6 - E Contents List 5.6
English List of Contents Supplement 5.6 - F Contents List 5.6
French List of Contents Supplement 5.6
- E Comments Supplement 5.6
- 5th Edition Supplement 5.5
- E Comments Supplement 5.5
Comments concerning some revised/corrected texts published in Supplement 5.5 - E Index 5th 5.5
English Cumulative Index 5th Edition 5.5 - F Index 5th 5.5
French Cumulative Index 5th Edition 5.5 - E Contents List 5.5
English List of Contents Supplement 5.5 - F Contents List 5.5
French List of Contents Supplement 5.5
- E Comments Supplement 5.5
- 5th Edition Supplement 5.4
- E Comments Supplement 5.4
Comments concerning some revised/corrected texts published in Supplement 5.4 - E List New Reagents
List of new reagents: Supplement 5.4 - F Index 5th 5.4
French Cumulative Index 5th Edition 5.4 - E Index 5th 5.4
English Cumulative Index 5th Edition 5.4 - E Contents List 5.4
English List of Contents Supplement 5.4 - F Contents List 5.4
French List of Contents Supplement 5.4
- E Comments Supplement 5.4
- 5th Edition Supplement 5.3
- E Comments Supplement 5.3
Comments concerning some revised/corrected texts published in Supplement 5.3 - E Index 5th 5.3
English Cumulative Index 5th Edition 5.3 - F Index 5th 5.3
French Cumulative 5th Edition 5.3 - E Contents List 5.3
English List of Contents Supplement 5.3 - F Contents List 5.3
French List of Contents Supplement 5.3
- E Comments Supplement 5.3
- 5th Edition Supplement 5.2
- E Comments Supplement 5.2
Comments concerning some revised/corrected texts published in Supplement 5.2 - E Index 5th 5.2
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Supplement 5.8 date of implementation = AP-CSP (06) 3 - APCSP0602E
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List of monographs deleted = AP/CSP (04) 4 - APCSP0403E
Supplement 5.3 date of implementation = AP/CSP (04) 03 - APCSP0402E
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List of monographs deleted = AP/CSP (02)6 - APCSP0204E
List of monographs deleted = AP/CSP (02)4 - APCSP0203E
Supplement 4.5 date of implementation = AP/CSP (02)03 - APCSP0201
Supplement 4.4 date of implementation = AP/CSP (02)01 - APCSP022E
List of monographs deleted = AP/CSP (02)2 - APCSP017E
Supplement 4.3 date of implementation = AP/CSP (01)07 - APCSP016E
List of monographs deleted = AP/CSP (01)6 - APCSP 015E
Supplement 4.2 date of implementation = AP/CSP (01)5 - APCSP 014E
List of monographs deleted = Res AP/CSP (01)4 - APCSP013E
Supplement 4.1 date of implementation = Res AP/CSP (01)3 - APCSP012E
List of monographs deleted = Res AP/CSP (01)2 - APCSP011E
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Unfractionated heparin as starting material for LMW heparins
Characterisation of LMW heparins - Session 2: Global harmonisation - Part 3
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Characterisation of UFH samples from the past decade
Physico-chemical characterisation - Session 2: Global harmonisation - Part 1
Characterisation of UFH samples from the past decade
Physio-chemical characterisation - Session 1: Contamination of heparin - Part 3
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Data from the field - market surveillance - batch results
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Plenary Session - Perspectives for co-operation: Partnership with Industry, 13th June 2007 (Part 3) - Plenary Session 15 June Part 2
Plenary Session - Action plan for the future: Recommendations from the Industry, 15th June 2007 (Part 2) - Plenary Session 15 June Part 1
Plenary Session - Action plan for the future: Recommendations from the Industry, 15th June 2007 (Part 1) - Russian Health and Pharmaceutical Authorities, The Russian Federation
Mr Nicolay Yurgel, Ministry of Healthcare and Social Development, 13th June 2007
- Plenary Session 13 June - Part 2
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- Building a partnership for investigation of counterfeit medicines
Workshop - Building a partnership for the investigation of counterfeit medicines - Certification: How to use a CEP
Workshop - Certification: How to use a Certificate - Certification: Inspections
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Workshop - Herbals: Implementation of the new legislative framework - Herbals: Traditional Chinese medicines
Workshop - Herbals: Traditional Chinese Medicines - Homoeopathy
Workshop - Homoeopathy - International harmonisation: Microbiological techniques
Workshop - International harmonisation: Microbiological techniques - New challenges for Pharmacopoeias
Workshop - New challenges for Pharmacopoeias - Partnership developed within the OMCLs
Workshop - Partnership developed within the Official Medicines Control Laboratories (OMCLs) - PDG and the ICH Q4B
Workshop - Pharmacopoeial Discussion Group & the ICH Q4B - Quality standards for biologicals
Workshop - Quality standards for biologicals - Reference standards
Workshop - Reference Standards: How to characterise them, key elements and qualification - Updating monographs & methods (Part 1)
Workshop - Updating monographs and methods (Part 1) - Updating monographs and methods (Part 2)
Workshop - Updating monographs & methods (Part 2) - Workshop Conclusions
Workshop Conclusions
- Building a partnership for investigation of counterfeit medicines
- Plenary Sessions 13th & 15th June
- Posters
- Conf Poster Session
Poster Session, 13-15 June 2007
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- Final Prog China, 23-24 May 2007
The European Pharmacopoeia 6th Edition - Shanghai, 23-24 May 2007
- Final Prog China, 23-24 May 2007
- India Symposium, 4-5 May
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Regulatory Submission Procedures in EU – APIs & Drug Products, Hyderabad, 4-5 May 2007
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- Working across disciplines and borders, 6-7 December
- 2006
- 2006 Conference Archive
2006 Conference Proceedings & Presentations - Europe against counterfeit medicines, Moscow, 23-24 October
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- Day 1, 23 October
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(Some speeches are only available in French) - Introduction
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- Avian Influenza Vaccines Symposium, Strasbourg, 19-20 October
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- Final Prog Avian Flu
Final Programme Avian Influenza Symposium, Strasbourg, 19-20 October
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Proceedings of the symposium on Avian Influenza Vaccines
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Final Programme Microbiology Chapters Symposium, Strasbourg, 2-3 October - List Participants Microbiology
List of participants, Microbiology Symposium, 2-3 October 2006
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Opening Session: New microbiology chapters - Session I: Part 1 Slides
Session I: Microbiological contamination of non-sterile products (Part 1) - Session I: Part 2 Slides
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Session II: Alternative methods for control of microbiological quality (Part 1) - Session II: Part 2 Slides
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Session II: Alternative methods for control of microbiological quality (Part 3)
- Opening Session
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Impurities Control: setting specifications for antibiotics and peptides - List Participants Impurities
List of participants, Impurities Control Symposium, 21-22 September 2006
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Issues discussed and the conclusions reached during the Antibiotics workshops (21 September 2006) - Peptides Presentations
Impurities control: setting specifications for Peptides (22 September 2006)
- Antibiotics Presentations
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Programme European Pharmacopoeia Symposium, 27 June, 14h00-16h00, Hall W2, Meeting Room M9
- Prog CPhI Sympo
- Presentations
- An overview of EDQM publications & online services - Mrs C. Larsen Le Tarnec
An overview of EDQM publications and online services - The Certification of Suitability to the PhEur monograph (CEP) - Dr C. Pouget
The Certification of Suitability to the PhEur monograph (CEP) - The PhEur: General concepts & specific monographs - a detailed analysis - Dr C.Coune
- An overview of EDQM publications & online services - Mrs C. Larsen Le Tarnec
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- Programme
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IDMA & EDQM Symposium, Mumbai, India, 23-24 January 2006
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2005 Conference Proceedings - IPC Congress, Hyderabad, India, 2-4 December
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Programme - IPC Congress, Hyderabad, India, 3 December 2005
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- Certification Conference, Istanbul, 27-28 October
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Programme: International Conference on Certification, 27-28 October 2005
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- Plenary Session
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Plenary Sessions Presentations, 27 & 28 October 2005
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- Rev Ren Presentations
Workshop 1: New procedures for the revision and renewal of certificates
- Rev Ren Presentations
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Workshop 2: An outline of the main deficiencies in dossiers and how to avoid them
- Deficiencies Presentations
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Workshop 3: Focus on sterile products - How to prepare a dossier and prepare for an inspection
- Sterile Presentations
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Workshop 4: Inspection of manufacturing sites: Chemical products
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- Plenary Session
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- Counteract the counterfeiters, Strasbourg, 21-23 September
- Introduction
- Organising Committee
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- Speakers
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- XpoPharm 2005, Seoul, Rep of Korea, 1-2 September
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XpoPharm 2005, Seoul, Rep of Korea, 2 September 2005
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- Session 1 Slides
Session 1: Organisation & Structure of the Network - Session 2 Slides
Session 2: Common programmes of supervision activities for the network
- Session 1 Slides
- Programme
- Alternatives to Whole Cell Pertussis Vaccine Potency Vaccine, 16 March
- Programme
- Pertussis Prog
Programme: Alternatives to whole cell pertussis vaccine potency assay
- Pertussis Prog
- Proceedings
- Pertussis vaccine PA proceedings
Proceedings of the symposium on Alternative to whole cell pertussis vaccine potency assay
- Pertussis vaccine PA proceedings
- Presentations
- General Intro
General Introduction: Whole cell pertussis vaccine quality control - Intro Talk
Alternatives: Humane and science-based improvements of whole cell pertussis vaccine quality control: An overview - Round Table Talk I
Policy of the Ph.Eur. for lot release of combined vaccines for human use. - Scientific Presentations
Scientific Presentations of data obtained with the Kendrick test & other alternatives - WHO Perspective
Potency testing of whole cell pertussis vaccine
- General Intro
- Programme
- Quality of homoeopathic products in the new European legislative framework, 15 February
- Programme
- List Participants Homoe
List of participants, Homoeopathy Symposium, 15 February 2005 - Prog Homoe Sympos
Programme Homoeopathy Symposium, 15 February 2005, Strasbourg, France
- List Participants Homoe
- Proceedings
- Homoeopathy Proceedings
Proceedings
Quality of homoeopathic products: Conference Proceedings, 15 February 2005, Strasbourg, France
- Homoeopathy Proceedings
- Presentations
- Session 1 General
Session 1: General European Regulatory Background - Session 2 Experience
Session 2: Experiences and viewpoint of national regulatory authorities and perspectives - Session 3 Future
Session 3: The future of homoeopathics in Europe
- Session 1 General
- Programme
- 2005 Proceedings Archive
- 2004
- 2004 Proceedings Archive
2005 Conference Proceedings - Quality on the Move: Dynamics of the European Pharmacopoeia, 4-6 October
- Programme
- List Participants Quality
Quality on the Move - List of Participants - Scientific Programme Quality
Scientific Programme Quality on the Move Conference, 4-6 October 2004, Budapest, Hungary
- List Participants Quality
- Proceedings
- Quality Proceedings
Quality on the Move: Conference Proceedings, 4-6 October 2004, Budapest, Hungary
- Quality Proceedings
- Presentations
- Quality Day 1 Session Ia
Day 1 Session Ia: Roles of the European Authorities - Quality Day 1 Session Ib
Day 1 Session Ib: Roles of the European Authorities - Quality Day 1 Session IIa
Day 1 Session IIa:Viewpoint of the Regulatory Authorities - EMEA Working Parties - Quality Day 1 Session IIb
Day 1 Session IIb:Viewpoint of the Ph.Eur. & its Partners, & Industry - Quality Day 2 Blood & Plasma
Day 2: Blood & Plasma Products Workshop - Quality Day 2 BSP
Day 2: Biological Standardisation Workshop - Quality Day 2 Cell & Gene
Day 2: Cell & Gene Therapy Products Workshop - Quality Day 2 Certification
Day 2: Certification Workshop - Quality Day 2 CRS BRP
Day 2: Pharmaceutical Reference Substances CRS/BRP - Quality Day 2 Excipients
Day 2: Excipients Workshop - Quality Day 2 Harmonisation
Day 2: International Harmonisation Workshop - Quality Day 2 Herbals
Day 2: Herbals Workshop - Quality Day 2 Impurities
Day 2: Impurities Workshop - Quality Day 2 Micro Tech
Day 2: Microbiological Techniques Workshop - Quality Day 2 Pharm Dosage Form & ST
Day 2: Pharmaceutical Dosage Forms & Standard Terms Workshop - Quality Day 2 Pharm Waters
Day 2: Pharmaceutical Waters - Quality Day 3 Session I
Day 3 Session I: Conclusions & Action Plan for the Future - Recommendations from the Industry - Quality Day 3 Session II
Day 3 Session II: Perspectives for the WHO, Int. Harmonisation & the 6th Edition
- Quality Day 1 Session Ia
- Programme
- Serological Potency Tests for Diphtheria and Other vaccines, 6-7 October
- Programme
- List of Participants
Serological Potency Tests Symposium - List of Participants - Scientific Programme Serological
Scientific Programme Serological Potency Tests for Diphtheria and Other Vaccines, 6-7th October 2004, Budapest, Hungary
- List of Participants
- Proceedings
- Diphtheria Proceedings
Serological Potency Tests for Diphtheria and Other Vaccines Conference Proceedings, 6-7th October 2004, Budapest, Hungary
- Diphtheria Proceedings
- Presentations
- Session I
Session I: Alternative to Challenge Assays in Animals for Vaccines Control - Session II
Session II: Perspectives for Combined Vaccines Control - Session III
Session III: Conclusions & Action Plan
- Session I
- Programme
- 40th Anniversary European Pharmacopoeia 15 June
- Programme
- Programme
Programme Official Ceremony 40th Anniversary European Pharmacopoeia
- Programme
- Programme
- Process Analytical Technologies 3-4 May
- Programme
- PAT Programme
PAT Scientific Programme 3-4 May, Cannes, France
- PAT Programme
- Proceedings
- PAT Proceedings
Process Analytical Technologies Conference Proceedings, 3-4 May 2004
- PAT Proceedings
- Presentations
- PAT-Session I
PAT Day 1 Session I Role of the Pharmacopoeia Slides - PAT-Session II
PAT Day 1 Session II Test Methods to be Applied Slides - PAT-Session IIb1
PAT Day 2 Session IIb1 Test Methods to be Applied Slides - PAT-Session IIb2
PAT Day 2 Session IIb2 Test Methods to be Applied Slides
- PAT-Session I
- Programme
- 2004 Proceedings Archive
- 2003
- 2003 Conference Archive
2003 Conference Proceedings & Presentations - Microbiology Symposium, 5-6 May
- Programme
- Microbiology programme
Symposium scientific programme (5-6 May 2003, Langelinie Pavillon, Copenhagen, Denmark)
- Microbiology programme
- Proceedings
- Proceedings microbiology
Proceedings Microbiology Symposium, 5-6 May 2003
- Proceedings microbiology
- Presentations
- Development Culture Media
Development of Culture Media. Slides session III. - Microbiological sterilisation processes
Microbiological Sterilisation Processes. Slides session V - Microbiological Testing
Microbiological Testing of Raw Materials. Slides session IV - Microbiology Alternative New Control Methods
Microbiological control methods. Slides session II. - Microbiology International harmonisation
Microbiological Control Methods and International Harmonisation, Slides session I - Microbiology Round Table Discussion
Round Table Discussion. Slides session VI.
- Development Culture Media
- Programme
- Foot
- Programme
- FMD programme
Symposium programme (17-18 March, EDQM Premises, Strasbourg, France)
- FMD programme
- Proceedings
- Foot and Mouth Disease
Foot and Mouth Disease proceedings, 17-18 March 2003
- Foot and Mouth Disease
- Presentations
- Introduction FMD
Introduction FMD vaccines, Slides session I - Requirements FMD efficacy
Requirements for a modern FMD vaccine: efficacy aspects to be dealt with, Slides session III - Requirements FMD vaccines
Requirements for a modern FMD vaccine: quality aspects to be dealt with, slides session II
- Introduction FMD
- Programme
- Cell and gene therapy Symposium, 24-25 February
- Programme
- Cell Gene Therapy Programme
Symposium on Standardisation and Quality Control Cell and Gene Therapy Products, Programme (24-25 February 2003), Hilton Hotel, Strasbourg, France
- Cell Gene Therapy Programme
- Proceedings
- Proceedings cell gene products
Standardisation and quality control cell and gene therapy products, 24-25 February 2003, Proceedings of the symposium.
- Proceedings cell gene products
- Presentations
- Cell Gene Developments
Latest Scientific Developments in Cell and Gene Therapy Products, Slides session I - Cell Gene Future
The Future, Slides session V - Cell Gene Regulatory
The Regulatory Issues, Slides session IV - Cell Quality Challenge
New Quality Challenges for Cell Therapy Products, Slides session II - Gene Quality Challenges
New Quality Challenges for Gene Therapy Products, Slides session III
- Cell Gene Developments
- Programme
- 2003 Conference Archive
- 2002
- 2002 Conference Archive
2002 Conference Proceedings & Presentations - 3Rs Symposium, 7-8 November
- Proceedings
- 3Rs proceedings
Symposium on 3Rs of the use of animals in the QC of vaccines, 7-8 November 2002, Proceedings of the symposium.
- 3Rs proceedings
- Presentations
- 3Rs future developments
Symposium on 3Rs of the use of animals in the QC of vaccines, 7-8 November 2002, Slides session 4 - 3Rs implementation needs practical aspects
Symposium on 3Rs of the use of animals in the QC of vaccines, 7-8 November 2002, Slides session 3 - 3Rs implementation regulatory
Symposium on 3Rs of the use of animals in the QC of vaccines, 7-8 November 2002, Slides session 2 - 3Rs regulatory scientific background
Symposium on 3Rs of the use of animals in the QC of vaccines, 7-8 November 2002, Slides session 1
- 3Rs future developments
- Proceedings
- Excipients, 4-5 April
- Proceedings
- Excipients proceedings
Excipients: Classical requirements and functionality related testing
- Excipients proceedings
- Proceedings
- ETIF
- Presentations
- ETIF CC
La farmacopea europea al nivel mundial: procedimiento de certificacion de conformidad y programa de trabajo del Pharmacopoeial Discussion group (PDG) ETIF 21-24 October 2002. Buenos Aires Argentina - ETIF MSJ
Farmacopea europea 4a Edicion: Que novedades presenta?ETIF 21-24 October 2002. Buenos Aires Argentina
- ETIF CC
- Presentations
- 2002 Conference Archive
- 2001
- 2001 Proceedings Archive
- Equine Influenza Vaccine, 10-11 December
- Proceedings
- Proceedings Equine
Quality control of equine influenza vaccines. Proceedings of the Workshop.
- Proceedings Equine
- Proceedings
- Pestavirus Contamination, 29-30 March
- Proceedings
- Proceedings pestivirus
Pestivirus contaminations. Proceedings of the symposium.
- Proceedings pestivirus
- Proceedings
- Certification of TSE products, 11 January
- Proceedings
- Proceedings TSE Risk
TSE risk products. Proceedings of the symposium.
- Proceedings TSE Risk
- Proceedings
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