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Session 2: The New ICH
Session Chair(s)
William Gregory, PhD
Senior Director, Safety and Risk Management
Pfizer Inc, United States
Since 1990, the International Conference on Harmonisation (ICH) has provided a consensus forum for drug regulators and the pharmaceutical industry to develop harmonized of scientific and technical requirements for registration of innovative pharmaceutical products. In October 2015, ICH announced organizational and process changes to expand formal participation of organizations beyond the EU, Japan, and the US. Further changes to the face of global biopharmaceutical product development were made in June 2017. This session will provide an overview of the current ICH. In addition, regulator and industry perspectives will be presented on global harmonization of a new topic, E-19 (optimization of safety data collection).
Speaker(s)
Overview of the Current ICH
Amanda Marie Roache, MS
Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Senior Director, Science and Regulatory Advocacy
The New ICH E19 Guideline on Optimization of Safety Data Collection (in Development): Regulatory Perspective
Ellis Unger, MD
Hyman, Phelps & McNamara, P.C., United States
Principal Drug Regulatory Expert