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Session 4 Track 1 - New Frontiers: Update on ICH: What You Need to Know

Track:
New Frontiers

Day & Time:
October 29, 3:30PM - 5:00PM

Type:
Session

Title:
Session 4 Track 1 - New Frontiers: Update on ICH: What You Need to Know

Chair(s):
Andrew Storey
Vice President, Regulatory Affairs United States and Canada
AbbVie, United States

Description:
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.

Presentation(s) & Speaker(s):
International Conference on Harmonization – Updates on Health Canada’s Involvement
Mike Ward
Manager, International Programs Division
Health Canada, Canada

DSURs
Hoda Eid, PhD,MSc
Manager, Office of Clinical Trials, Adverse Drug Reaction Division
Health Canada, Canada

RMPs
Rania Mouchantaf, PhD
Scientific Evaluator
Health Canada, Canada

PBRERs
Vicky Hogan, PhD,MSc
Director, Office of Risk Management and Science, Marketed Health Products Direct
Health Canada, Canada

Industry Perspective
Sarah A. Frise, PhD,MSc
Director, Patient Safety and Medical Information
AstraZeneca, Inc., Canada

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