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.
- NEW! 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 & 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