28th APIC/CEFIC Global GMP & Regulatory API Conference

Wednesday | 22 October

The first day of the Conference provides, besides the first set of Parallel Sessions with various GMP and RA topics, updates about AEMPS’, EDQM’s and PMDA’s activities, the revision of the ICH M4Q Guideline and recent developments in mutagenic impurities.

The Experience of AEMPS with the ASMF Procedure
Teresa Dannert Alsasua, AEMPS

  • AEMPS contribution in National and European procedures
  • ASMF procedure:
    • An analysis of its use in National and European procedures
    • Frequently asked questions
    • AEMPS’ experience with the EU ASMF worksharing procedure

Recent Developments in Mutagenic Impurities, with Focus on Nitrosamines
Ajda Podgorsek Berke, Lek Pharmaceuticals, a Sandoz company
Filip De Bock, Lek Pharmaceuticals, a Sandoz company

  • Overview of the regulatory guidelines – recent updates
  • Recent developments in mutagenic impurities, with focus on nitrosamines
  • Challenges & Impact on industry
  • Way forward

Revision of the ICH M4Q Guideline from a Regulator’s Perspective
Ivica Malnar, Halmed

  • M4Q(R2) revision update – current EWG thinking
  • New organisation in presenting quality information
  • ICH M4Q(R2) implementation challenges
  • A Regulator’s perspective

The new Amendments to the Japanese Pharmaceuticals and Medical Devices Act
tba. PMDA Speaker

  • The recent situation related to pharmaceutical regulations in Japan
  • Details of the amendments

Update on EDQM Activities
Bruno Spieldenner, EDQM

  • The European Pharmacopoeia (Ph. Eur.)
  • EDQM’s activities with regard to the CEP procedure
  • EDQM’s international co-operation with other authorities

Thursday | 23 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. regulatory starting materials, API manufacturer inspections and the risk-based approach for like-to-like changes.

Quality Oversight Requirements for Contract Manufacture
Anthony Storey, Pfizer

  • The importance of contract manufacturing to the industry
  • The need for oversight/governance for such activities
  • What makes a good partnership model for both parties

Use of Recovered Solvents in API Production: Reducing the Environmental Footprint
Joris Gilberts, Aspen Oss

  • Reducing the environmental footprint of APIs: use of recovered solvents
  • Position of APIC’s TF on current challenges
  • Roadmap of APIC’s TF to come with practical guidance

EU Pharmaceutical Package – an Update
Hilde Vanneste, J&J Innovative Medicine

  • Understanding the EU Pharmaceutical Package
  • Positive impacts and challenges of the EU Pharmaceutical Package
  • Overview of the update of the classification guideline
  • Impact on industry practises
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