International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Quality Implementation Working Group (Q-IWG): Integrated Implementation Training Workshops for ICH Q8, Q9 and Q10

• Date:
  Wednesday, 2 June 2010, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

Practical training on integrated implementation of Q8, Q9 and Q10 in pharmaceutical development, manufacturing, regulatory assessment, scale up to commercial operation, and good-manufacturing-practice (GMP)inspections. This is an opportunity for open dialogue among industry and regulators on comprehensive training on regulatory aspects, technical development and manufacturing; case study combining Q8, Q9 and Q10; and regulatory topics related to submission expectations and GMP inspections.