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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.
Events listed by topic
- Chemicals
- Microbiology
- European Pharmacopoeia : tackling future challenges of the quality of medicines
- Quality requirements for Fish Vaccines
- The Chinese and European Pharmacopoeias – The new editions
- Certification Procedure CEPs
- Electronic Submissions for CEP applications
- Generic Drug Regulators Programme
- European Symposium IV. Wildbad Kreuth Initiative - Optimal use of clotting factors and platelets
You can also access the Ph. Eur. Training Resources
Chemicals
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
Microbiology
International 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
International conference 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
Workshop 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
International conference 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
Workshop 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
Symposium 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
Optimal use of clotting factors and platelets
European Symposium IV. Wildbad Kreuth Initiative 6-7 May 2016, Freising, Germany