This year’s Information Day will focus on the recent reforms by ICH and what this means for global development of medicines. Participants will hear how ICH is moving towards being a truly global platform for regulators and industry to achieve the objective of ‘Harmonisation for Better Health’.
Learn directly from the experts: Sessions include Q&A with Dawn Ronan, Director of the ICH Secretariat, Tomas Salmonson EMA, EU and Richard Bergström, EFPIA, Belgium
The success of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is largely due to its unique model that brings together regulatory authorities and pharmaceutical industry from Europe, Japan and the US to discuss scientific and technical aspects. Since its launch in 1990, ICH has evolved and responded to the increasing globalisation of pharmaceutical development and the need for international regulators outside the initial 3 regions to work together to respond to these new challenges. Following the reforms, ICH has become "the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use" and established as an international non-profit Association under Swiss law on 23 October 2015" The reforms mean that ICH becomes a truly global initiative, expanding beyond the current ICH members. Regulatory authorities and international pharmaceutical industry organisations that are affected by ICH guidelines may apply to become Members or Observers of the Association.
Martin Harvey Allchurch, LLM • Principal International Affairs Officer
European Medicines Agency, European Union, United Kingdom
Lenita Lindström Gommers • ICH Assembly Chair and Senior Expert, European Commission
European Commission, Belgium
Tomas Salmonson, PhD • EMA CHMP Chair; Senior Assessor
Swedish Medicines Agency, Sweden