Live Online Conference: 23rd APIC/CEFIC Global GMP & Regulatory API Conference 2020 - Regulatory Affairs part

Live Online Conference: 23rd APIC/CEFIC Global GMP & Regulatory API Conference 2020 - Regulatory Affairs part

Course No 17695


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Hélène Bruguera, EDQM France
Marieke van Dalen, Aspen Oss B.V., The Netherlands
Katherine Eban
Stephan Heck, Catalent Pharma Solutions, Germany
Dr Sau (Larry) Lee, US FDA, USA
George Hartong van Lokven, Aspen Oss B.V., The Netherlands
Nuno Matos, Hovione, USA
Beate Miller, DSM Nutritional Products, Switzerland
Frank Montgomery, AstraZeneca
Ibrahim H. Mujammami, SFDA, Saudi Arabia (invited)
Jeong-Ja Oh, Synex Consulting, South Korea
Cathal O’Duinn, Janssen Pharmaceuticals, Ireland
Rosimeire Pereira Alves da Cruz, ANVISA, Brazil
Fabio Polato, Sandoz, Austria
Florent Trouillet, Siegfried, Switzerland
Dieter Vanderlinden, Ajinomoto Bio-Pharma Services, Belgium
Stefaan van de Velde, Ajinomoto Bio-Pharma Services, Belgium


The APIC/CEFIC Global GMP & Regulatory API Conference is Europe’s leading API event. Many major stakeholders from Authorities and the Industry are joining this Conference each year. Speakers from EMA, EDQM, FDA, National Authorities, the Industry and Industry Associations will discuss the latest developments in the field of GMP and Regulatory Compliance.
After several regulatory topics will have been presented during the second conference day, the RA part of the conference will highlight key aspects of registration procedures in Saudi Arabia and Korea as well as, aspects of future ASMF assessment and CEP modernisation.
The Parallel Sessions are no workshops. They are practically oriented and supposed to be highly interactive.


Parallel Sessions
Quality culture
Stephan Heck, Catalent Pharma Solutions
  • What is quality culture?
  • Why is the quality culture of an organisation important to APIs and patients?
  • How is the quality culture of an organisation developed?
  • How can you assess an organisation quality culture?
Specifics for Sterile APIs
Fabio Polato, Sandoz
  • Sterile API production – Annex 1 GMP
  • Regulatory consequences
  • The relationship with the customers
ICH Q13 – Continuous Manufacturing of Drug Substances and Drug Products
Nuno Matos, Hovione
  • ICH Q13 purpose
  • Continuous Manufacturing process benefits for Industry
  • Guideline status and next steps
API registration in Brazil: an overview
George Hartong van Lokven, Aspen Oss B.V.
  • Brazil specifics
  • Registration procedures: past, present and future
Cleaning in multipurpose facilities
Florent Trouillet, Siegfried (Evionnaz)
  • Health authorities’ requirements and cleaning challenges for multipurpose facilities
  • Criteria for risk analyses to develop cleaning methods and cleaning validation strategy in a multipurpose facility
  • Risk-based approach for limit setting on intermediates and early development products
  • Practical examples
APIC´s Experience with API Registrations in China
Beate Miller, DSM Nutritional Products
  • The Regulatory Framework in China
  • Chinese DMF Requirements
  • Experience of APIC Members & Case Studies
Joint GMP And Regulatory Affairs part
Update from EDQM
Hélène Bruguera, EDQM
  • Latest news on the certification scheme
  • The EDQM inspection programme
Latest developments in nitrosamine impurities – impact to the API industry
Speaker to be announced, Member of the APIC Task Force on Nitrosamines
  • Why are nitrosamines a concern?
  • What is expected from the API Industry from a GMP and regulatory perspective?
  • Interactions between API Industry and marketing authorisation holders
ICH Q12 - Now the hard work starts in implementation
Frank Montgomery, AstraZeneca
  • How to define ECs and where in the CMC should they be listed
  • PACMP – advantages and how to use
  • PLCMP – advantages and how to use
Innovation and continuous manufacturing
Dr Sau (Larry) Lee, FDA
  • FDA’s efforts to modernize drug manufacturing
  • Guidance for Industry: Quality Considerations for Continuous Manufacturing
  • Batch vs. continuous manufacturing
  • FDA’s Emerging Technology Program
Regulatory Affairs part
API Filing in South Korea: What do Korean Authorities expect?
Jeong-Ja Oh, Synex Consulting
  • Overview on South Korean DMF System
  • Experiences with DMF Procedure and Watch-outs
CEP modernisation : an APIC perspective
Marieke van Dalen, Aspen Oss
  • Improvements to the current system
  • Outlook to the future
Saudi Arabia, Gulf States: Registration procedures for APIs
Ibrahim H. Mujammami,SFDA (invited)
  • The Regulatory Framework
  • Registration procedures for APIs
  • International collaboration
Future of ASMF assessment
Speaker to be announced

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