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 ‘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 ‘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)
Register for FREE and receive the webinar recording
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