Analytical Method Development, Validation and Transfer

Informa life Sciences Analytical Method Development, Validation and Transfer is a dedicated forum focusing solely on new method development, validation and transfer for pharmaceutical and generics man


Informa life Sciences Analytical Method Development, Validation and Transfer is a dedicated forum focusing solely on new method development, validation and transfer for pharmaceutical and generics manufacturers. The event is the only of its kind to feature case study benchmarking supplemented with regulatory authority feedback and advice from US and EU agencies.

Key themes for the 4th annual event include: streamlining new method development, effective transitions to new technologies, establishing compliant yet efficient method validation and exploiting Quality be Design.

Key features of the 2014 conference:
• Regulatory agency feedback on validation procedures, New FDA draft guidance and QbD filings
• 10 in-depth industry case studies across new method development, validation and transfer
• 4 new interactive sessions designs for experience sharing, industry benchmarking and enhanced networking
• Assessment of industry readiness for ICH Q3D (Draft guidance for elemental impurities), including: Preparation strategies from UCB and audience poll

Hear from and make new contacts, including:
Regulatory agency representatives:
• Simeon Gill, Pharmaceutical Assessor, MHRA, UK
• Alfred V. Del Grosso, Team Leader, Chemistry, U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research, Division of Biological Standards and Quality Control, USA

Industry practitioners:
• Joachim Ermer, Head of Quality Control Services, Frankfurt Chemistry & Global Reference Standards Coordinator, Sanofi, Germany
• Holger Memmesheimer, Vice President -Respiratory Drug Delivery, Boehringer Ingelheim Pharma GmbH & Co.KG, Germany
• Annick Gervais, Director Physico-Chemical Method Development, Analytical Sciences for Biologicals, UCB, Belgium
• Christine Weber, Head of Department, Analytical Development Substance,
H. Lundbeck A/S, Denmark