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Session 4 Track 1 - New Frontiers: Update on ICH: What You Need to Know
Session Chair(s)
Andrew Storey
Vice President, Regulatory Affairs United States and Canada
AbbVie, United States
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has evolved to respond to the increasingly global face of drug development, so that the benefits of international harmonization for better global health can be realized worldwide. From CTD to MedDRA to the many Quality guidelines now available, there has been significant revolution as a result of the organization's output. ICH has been particularly prolific of late producing some key and much anticipated documents that will have a major impact on regulators and industry. The panel will review some of the key developments and publications, the involvement of Health Canada, and some of the changes contemplated for ICH as it assesses new ways to add even more value in future.
Speaker(s)
International Conference on Harmonization – Updates on Health Canada’s Involvement
Mike Ward
World Health Organization (WHO), Switzerland
Coordinator, Regulatory Systems Strengthening, EMP
DSURs
Hoda Eid, PhD, MSc
Health Canada, Canada
Manager, Office of Clinical Trials, Adverse Drug Reaction Division
RMPs
Rania Mouchantaf, PhD
Health Canada, Canada
A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD
PBRERs
Vicky Ann Hogan, PhD, MSc
Health Canada, Canada
Manager, Blood Tissues and Organs Scientific Section
Industry Perspective
Sarah Frise, PhD, MS
AstraZeneca, Canada
Global Head Safety Epidemiology and Risk Management
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