ASEAN Training on ICH Q5C Guideline : ICH

ICH Q5 Guideline
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ASEAN workshop, 30-31 May 2011, Kuala Lumpur, Malaysia

In May 2011, a 2 day workshop on the ICH Q5C Guideline was organised in Kuala Lumpur, Malaysia.

The workshop welcomed 119 participants from 10 different national Regulatory authorities member of ASEAN.

Speakers included a number of ICH experts from the European Medicines Agency.

Workshops

Day 1
- Introduction to the ICH GCG
  
  ICH and EU regulatory framework
  Dr. Alberto Ganan Jimenez, Quality of Medicines, European Medicines Agency
- Session I: Characterisation and Stability of Biologicals
  
  Scope of ICH Q5C Guideline/Terminology
  Dr. Alberto Ganan Jimenez & Dr. Brigitte Brake, European Medicines Agency (EMA) – German Federal Institute for drugs and medical devices (BfArM)
  
  Case Studies
- Session II: Comparability and Development of Biologicals
  
  ICH Q5E Comparability of Biotechnological/ Biological Products
  Dr. Brigitte Brake, German Federal Institute for drugs and medical devices (BfArM)
Day 2
- Session III: Specifications : Test Procedures and Acceptance Criteria
  
  Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
  Dr. Brigitte Brake, German Federal Institute for drugs and medical devices (BfArM)
- Session IV: European Experience and Challenges On Biologicals
  
  Biosimilars in the European Union - Regulatory perspectives
  Dr. Alberto Ganan Jimenez & Dr. Brigitte Brake, European Medicines Agency (EMA) – German Federal Institute for drugs and medical devices (BfArM)
  
  Advanced Therapy Medicinal Products (ATMPs) - EU experience
  Dr. Alberto Ganan Jimenez & Dr. Brigitte Brake, European Medicines Agency (EMA) – German Federal Institute for drugs and medical devices (BfArM)

At a Glance...

30-31 May 2011Kuala Lumpur, Malaysia