29th APIC/CEFIC Global GMP & Regulatory API Conference
Wednesday | 21 October
The first day of the Conference provides, besides the first set of Parallel Sessions with various GMP and RA topics, updates about ICH’s, FDA's, EDQM’s and the Danish Authoritie’s activities, a planery discussion about the new EU Variations Regulation.
GMP Inspections of API Manufacturers – Point of view of the Danish Inspectorate
Thomas Noe Vestergaard Pedersen, Danish Medicines Agency
Poul Vibholm Petersen, Danish Medicines Agency
- GMP Inspections in Europe and abroad
- Chemical and Biologic APIs
- Experiences and Expectations
- Consequences of Non-Compliance
Update on ICH M4Q
Lawrence Yu, FDA
New EU Variations Regulation – Penal Discussion
with
Virginia Rojo Guerra, EMA, The Netherlands
Andrei Catalin Spinei, EMA, The Netherlands
Hélène Bruguera, EDQM, France
Søren Thuesen Pedersen, EFPIA, Belgium
Indiana Castro, Medicines for Europe, Belgium
Hilde Vanneste, J&J Innovative Medicine, Belgium
Semi-Continuous Small Molecule API Intermediate Manufacturing – A Case Study
Peter Corbett, Pfizer
- Challenges faced launching a new product with a continuous manufacturing component
- Quality, manufacturing & control considerations
- Regulatory engagement & expectations
Update on EDQM Activities
Bruno Spieldenner, EDQM
- News of the CEP procedure
- News of the European Pharmacopoeia
- Environmental sustainability initiatives
Thursday | 22 October
The API world is changing rapidly. On the second day, the focus will be on the second set of Parallel Sessions about e.g. reshoring, real time release, and regulatory reliance beyond Europe.
Update from ANVISA
Rosimeire Pereira Alves da Cruz, ANVISA
Renan Gois, ANVISA
- Experiences with the optimized procedure for GMP certification
- Update on projects
The International Pharmaceutical Regulators Programme (IPRP)
Hélène Bruguera, EDQM
- What is the IPRP?
- IPRP mission, strategic vision and relationships with other international platforms
- Focus on the Quality Working Group
Complex pharmaceutical molecules – Complex regulations?
Wouter Maalcke, Synthon
- What are complex molecules?
- Regulatory landscape for synthetic peptides and synthetic oligonucleotides
- Overview of analytical challenges
- APIC Synthetic Peptides taskforce
AI in GMP Quality Systems: From Hype to Trusted Practice
Sandra Maria Lopes Guerreiro, Esteve
- Practical insights into how AI is reshaping quality and regulatory practices (beyond the hype)
- Risk management and Data Integrity governance for AI tools in regulated environments
- Implementation challenges & lessons learned from industry adoption
- Building trust between quality professionals and digital innovation teams
- Regulatory perspectives: how authorities view AI-assisted quality systems