Below you will find the most recent conference proceedings.
For archive files of all other conference proceedings, please go to our "Past events" section in the menu to the right.
- EDQM Webinar ‘Impurity Control in the European Pharmacopoeia’ (Recorded on 6 May 2021)
- EDQM Webinar ‘Approaches for CEPs and the Ph. Eur. strategy with regard to nitrosamine control: Current guidance and practical implementation’ (Recorded April 2021)
- EDQM Webinar ‘Using recombinant factor C for bacterial endotoxin testing in the Ph. Eur.: how far have we come, how far have we to go?’ (Recorded on 8 April 2021)
- Joint EDQM EPAA JRC Workshop Webinars: ‘Novel in-vitro model as alternative to in-vivo toxoid vaccines testing: Clostridium septicum vaccine as proof of concept’ (Webinar recorded on 9 and 10 March 2021)
- N-Nitrosamine impurities: Latest update on the Ph. Eur. approach (Webinar recorded on 21 January 2021)
- Meet the World Pharmacopoeias Symposium
- EDQM & European Pharmacopoeia: State-of-the-art Science for Tomorrow’s Medicines
- 13th International Symposium on Pharmaceutical Reference Standards
- Chinese and European Pharmacopoeia Joint Workshop: What’s New in the field of excipients in China
- International Microbiology Symposium
- The place of the Certification Procedure in the global regulatory environement
- The Chinese and European Pharmacopoeias – The new editions
- European Pharmacopoeia: tackling future challenges of the quality of medicines
- Electronic Submissions for CEP applications
- Generic Drug Regulators Programme
- The Challenges of Quality Requirements for Fish Vaccines
- IV Wildbad Kreuth Initiative - Optimal use of clotting factors and platelets
You can also access the Ph. Eur. Training Resources
EDQM Webinar ‘Impurity Control in the European Pharmacopoeia’ (Recorded 6 May 2021)
EDQM Webinar ‘Approaches for CEPs and the Ph. Eur. strategy with regard to nitrosamine control: Current guidance and practical implementation’ (Recorded April 2021)
EDQM Webinar ‘Using recombinant factor C for bacterial endotoxin testing in the Ph. Eur.: how far have we come, how far have we to go?’ (recorded on 8 April 2021)
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Joint EDQM EPAA JRC Workshop Webinars: "Novel in-vitro model as alternative to in vivo toxoid vaccines testing: Clostridium septicum vaccine as proof of concept" (webinar recorded on 9 and 10 March 2021)
Workshop Webinar 9 March 2021
- Presentations
- EDQM Activities in the field of 3Rs, by Catherine Lang
- EPAA activities in the field of 3Rs, by Irene Manou
- EURL ECVAM activities in the field of 3Rs, by Marlies Halder
- The BSP Programme, by Catherine Milne
- Outline of BSP130 Part 1, by Keith Redhead
- Method optimisation and their principles, by Balazs Dalmadi
- Statistics, by David Le Tallec
- Results Overview, by Botond Siklodi
- Feedback from BSP130 participants, by Marie-Emmanuelle Behr-Gross and Catrina Stirling
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Workshop Webinar 10 March 2021
- Presentations
- Achievements and issues for Ph. Eur. Group of experts 15V, by Lukas Bruckner
- Feedback from industry and way forward, by David John
- Regulators’ perspective from Europe, by Esther Werner
- Regulators’ perspective from the USA, by Angela Walker
- Experience in extending the approach of cell-based TCP and MLD assays, by Arjen Sloots
- Perspectives for extending the approach to other toxoid vaccines, by Mohammad Daas
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N-Nitrosamine impurities: Latest update on the Ph. Eur. approach (Webinar recorded on 21 January 2021)
- Interesting website links referred to in the presentations
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Meet the World Pharmacopoeias Symposium, 20 February 2020, Strasbourg, France
- Final programme
- General background of the International Meeting of World Pharmacopoeias (IMWP) and feedback from the 11th IMWP on 18-19 February 2020, by Sabine Kopp, WHO
- Good Pharmacopoeial Practices (GPhP) and future interactions between the Pharmacopoeial Discussion Group (PDG) and world pharmacopoeias, by Cathie Vielle, European Pharmacopoeia Dept., EDQM, Council of Europe
- Latest progress of the Chinese Pharmacopoeia 2020 and an overview of ChP International Cooperation, by Yue Shang, Chinese Pharmacopoeia Commission
- The Future of Pharmacopeial Collaboration, by Jeff Moore, U.S. Pharmacopeia
- Control Strategies of Genotoxic Impurities in Drug Substance & Product, by Anuj Prakash, Indian Pharmacopoeia Commission
- Vision and Expectations of the Japanese Pharmacopoeia, by Haruhiro Okuda, Japanese Pharmacopoeia
- Vision and expectations of the Mexican Pharmacopoeia, by Rafael Hernandez, Mexican Pharmacopoeia
- Brazilian Pharmacopoeia: vision and expectations for cooperation and convergence, by Arthur Leonardo Lopes Da Silva, Brazilian Pharmacopoeia
- EDQM’s Vision and Expectations for the IMWP, by Susanne Keitel, European Pharmacopoeia/EDQM
- Meet the World Pharmacopoeias Symposium, by Graham Cook, International Federation of Pharmaceutical Manufacturers and Associations
- Industry Perspective - Pharmacopoeial Evolution, by Janeen Skutnik-Wilkinson, International Pharmaceutical Excipients Council
- World Pharmacopoeia: APIC Expectations, by Jens Brillaut, Active Pharmaceutical Ingredients Committee
- Global Approaches to Emergent Challenges, by Karen Foster, Association of the European Self-Medication Industry
EDQM & European Pharmacopoeia: State-of-the-art Science for Tomorrow’s Medicines, 19-20 June 2019, Strasbourg, France
- Programme
- Opening Plenary Session part 1
- Opening Plenary Session part 2
- Workshop on Impurities
- Workshop on Finished Product Monographs
- Workshop on General Methods
- Workshop on Biotherapeutics
- Workshop on the 3Rs and ATMPs
- Workshop on Certification
- Workshop on OMCL Network
- Closing Plenary Session
- Poster Session
13th International Symposium on Pharmaceutical Reference Standards, 13-14 March 2019, Strasbourg, France
- Programme
- Session 1 : Compendial Reference Standards
- Session 2 : Pharmaceutical Reference Standards Small Molecules
- Session 3 : Pharmaceutical Reference Standards for biologicals
- Session 4 : Regulatory Aspects
- Posters
Chinese and European Pharmacopoeia Joint Workshop: What’s New in the field of excipients in China, 18 September 2018, Strasbourg, France
Access the presentations (pdf format)
- Chinese Pharmacopoeia (ChP) and Progress in the Compilation of ChP 2020, Mr Zhang Wei
- Guidance on Pharmaceutical Excipient Suitability Studies (PESS) with Chinese Pharmacopoeia (Volume 4): Basics and Examples, Dr Jiasheng Tu
- Establishment and Progress of the Standard System of pharmaceutical excipients in Chinese Pharmacopoeia, Dr Xiaoxu Hong
- Risks, Classifying Management and Technical Requirements for Pharmaceutical Excipients, Dr Xiaoxu Hong
- Submission Requirements for the Registration Application Dossier of Pharmaceutical Excipients, Dr Jiasheng Tu
- Regulation of Pharmaceutical Excipients in China, Dr Jiasheng Tu
- Considerations for Production and Quality Control of Animal Derived Pharmaceutical Excipients, Dr Xiaoxu Hong
- Pharmacopoeial Convergence and Harmonisation, Dr Susanne Keitel
Access the recorded presentations (video format)
Timecodes:
0:09 Zhang Wei - Chinese Pharmacopoeia ChP
1:29 Jiasheng Tu - Guidance on Pharmaceutical Excipient Suitability Studies with ChP
2:01 Xiaoxu Hong - Establishment SSPE in ChP
4:26 Xiaoxu Hong - Risks, classifying, technical requirements Pharmaceutical excipients
4:58 Jiasheng Tu - Submission Requirements for Registration application dossiers
5:26 Jiasheng Tu - Regulation Pharmaceutical excipients in China
5:42 Xiaoxu Hong - Considerations for Production & QC for animal derived excipients
7:40 Susanne Keitel - Pharmacopoeial Convergence and Harmonisation
International Microbiology Symposium, 10-11 October 2017, Strasbourg, France
Access the presentations (pdf format)
- EU Regulations for Medicines, by Cathie Vielle
- Sterilisation and biological indicators
- Rapid Microbiological Methods: Regulatory Perspectives 1
- Rapid Microbiological Methods: Regulatory Perspectives 2
- Rapid Microbiological Methods: examples of Success Stories
- Microbiological Control of Cell Therapy Products
- Microbiological Quality of Water
The place of the Certification Procedure in the global regulatory environement, 19-20 September 2017, Prague, Czech Republic
Access the presentations (pdf formats)
Day 1: Plenary session
- New developments of the European Pharmacopeia and their impact on the Certification Procedure, by Torbjörn Arvidsson
- The place of the Certification procedure in 2017 in the EU regulatory framework and beyond, by Hélène Bruguera
- Experience with CEPs from a European regulatory authority perspective, by Blanka Hirschlerová
- Experience with CEPs from the perspective of finished products manufacturers by Helen Robbins
- Experience with CEPs from the perspective of API manufacturers, by Marieke Van Dalen
- Experience with CEPs from the perspective of Indian manufacturers, by Gopal Joshi
- Experience with CEPs from the perspective of Chinese manufacturers, by Hong Xie
WORKSHOP 1: How to build a good CEP application
WORKSHOP 2: GMP inspections of API manufacturers
WORKSHOP 3: How to successfully prepare electronic submissions for CEPs
Day 2: Plenary session
- An overview of international initiatives in the regulatory sphere, by Cordula Landgraf
- The EU ASMF Work-sharing programme, by Nienke Rodenhuis
- The International Generic Drug Regulators’ Programme (IGDRP) initiative, by Gary Condran
- International cooperation for inspections of API manufacturers, by Monika Mayr
- CEPs: Views from Anvisa, Brazil, by Jeanne Sophie Cavalcante Lemos Gautier
- CEPs: Views from South Africa, by Mabatane Davis Mahlatji
- CEPs: Views from Canada, by Alison Ingham
The Chinese and European Pharmacopoeias - The new editions, 17 October 2016, Strasbourg, France
English versions
- Overview of Chinese Pharmacopoeia Commission (ChPC) & Update of Chinese Pharmacopoeia (ChP)
- Chinese Pharmacopoeia 2015 Vol. I
- Overview of New Admissions and Revisions in Chinese Pharmacopoeia 2015 Volume II
- Overview of the Pharmacopoeia of the Peoples Republic of China 2015 Volume III
- Brief Introduction of Chinese Pharmacopoeia 2015 Vol. IV
- Ph.Eur Reference Standards
- The European Pharmacopoeia Part 1
- General methods, Control of impurities, FP monographs, Pharmacopoeial harmonisation
- The European Pharmacopoeia Part 3
- The procedure of Certification of Suitability to the Monographs of the European Pharmacopoeia (CEP) and the EDQM Inspection Programme
Chinese versions
- Overview of Chinese Pharmacopoeia Commission (ChPC) & Update of Chinese Pharmacopoeia (ChP)
- Chinese Pharmacopoeia 2015 Vol. I
- Overview of New Admissions and Revisions in Chinese Pharmacopoeia 2015 Volume II
- Overview of the Pharmacopoeia of the Peoples Republic of China 2015 Volume III
European Pharmacopoeia: tackling future challenges of the quality of medicines, 27-28 September 2016, Tallinn, Estonia
- Plenary Day 1
- Workshop - Setting Pharmacopoeial Standards for Biotherapeutic Products - afternoon
- Workshop - Setting Pharmacopoeial Standards for Biotherapeutic Products - morning
- Workshop - Control of Elemental Impurities
- Workshop - New technologies
- Workshop - Excipients Other Components and International Harmonisation
- Closing Plenary Day
Electronic Submissions for CEP applications, Webinar recorded on 26 May 2016
International Generic Drug Regulators Programme, 13 May 2016, Strasbourg, France
- Dr Craig Simon's presentation on "IGDRP - Mission, Scope, How it works"
- Dr Craig Simon's presentation on "Update from the IGDRP Biowaivers Working Group"
- Mrs Mariana Gebara's presentation on the "IGDRP Quality working group"
- Dr Peter Bachmann's presentation on "Information and work sharing models"
- Dr Cappucino's presentation on "Licencing of Generic Products Worldwide - Needs and Expectations of Industry"
- Ms Marieke van Dalen's presentation on "International harmonization, and APIC view: our hopes and fears"
- Mr Johannes Koch's presentation on "AESGP views"
- Dr Xu Ming's presentation on "To jointly create an ecosystem for value-based medicines"
- Mr Dillip Shah's presentation on "Licensing of Generic Products: needs and expectations of industry".
The Challenges of Quality Requirements for Fish Vaccines, 10-11 May 2016, Strasbourg, France
- Programme
- Session 1 General Overview on Current Legal Requirements (Part 1)
- Session 1 General Overview on Current Legal Requirements (Part 2)
- Session 2a: Batch Potency Test – Point of View of Manufacturers
- Session 2b: Batch Potency Test – Point of View of Academia
- Session 2c: Batch Potency Test – Point of View of Authorities