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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)
Gabriele Schwarz, MPHARM
EC ICH E6(R3) Expert Working Group Member, Germany
Revision of ICH6 E6 GCP
Rebecca Stanbrook, RPH
EFPIA ICH E6(R3) Expert Working Group Member, RESaltas GmbH, Switzerland
Revision of ICH6 E6 GCP
Nick Lee, PHD
Executive Pharmaceutical Assessor, Health Products Regulatory Authority (HPRA), Ireland
New Guideline ICH Q13 - Continuous Manufacturing
Manuela Braun, DRSC
Senior Scientific Expert - Preclinical Development of Gene & Cell Therapy Produc, Bayer AG, Germany
New Guideline on Nonclinical Biodistribution Considerations for Gene Therapy
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