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ICH Townhall, Part 2
Session Chair(s)
Pär Tellner, MPharm, MSc, RPh
Director, Regulatory Affairs
EFPIA, Belgium
This session will provide stakeholders an in-depth information session on selected ICH guidelines (efficacy, quality and safety) and will give stakeholder the possibility to interact with the experts that have contributed to the harmonisation work.
Learning Objective : 1. Provide stakeholders an update on three selected ICH guidelines that are currently being revised or have been finalized recently: a. ICH E6 (R2) Good clinical practice b. ICH guideline Q13 on continuous manufacturing of drug substances and drug products c. ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals 2. Questions & Answers session on the three ICH guidelines
Speaker(s)
Revision of ICH6 E6 GCP
Gabriele Schwarz, MPharm
Germany
EC ICH E6(R3) Expert Working Group Member
Revision of ICH6 E6 GCP
Rebecca Stanbrook, RPh
Switzerland
EFPIA ICH E6(R3) Expert Working Group Member
New Guideline ICH Q13 - Continuous Manufacturing
Nick Lee, PhD
Health Products Regulatory Authority (HPRA), Ireland
Executive Pharmaceutical Assessor
New Guideline on Nonclinical Biodistribution Considerations for Gene Therapy
Manuela Braun, DrSc
Bayer AG, Germany
Senior Scientific Expert - Preclinical Development of Gene & Cell Therapy Produc