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FDA - Health Canada Regulatory Cooperation Council (RCC) Town Hall

Track:
Global Regulatory

Day & Time:
June 17, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
299F

Room Number:
11A

Level:
Intermediate

Type:
Forum

Title:
FDA - Health Canada Regulatory Cooperation Council (RCC) Town Hall

Chair(s):
Sema D. Hashemi, MSc
Office of International Programs, Office of the Commissioner
FDA, United States

Description:
At the request of stakeholders, FDA and Health Canada will highlight their work and lessons learned under the four Regulatory Cooperation Council (RCC) initiatives on the electronic submission gateway, common monographs for over-the-counter drugs, good manufacturing practices and veterinary drugs. Presentations will be followed by a question and answer period on next steps in the RCC process. Stakeholders are encouraged to express their views and innovative ideas as regulators discuss the future of RCC..

You may submit questions and topics of interest in advance to annualmeetingprogram@diahome.org, and include “RCC Town Hall” in the subject line.

Learning Objective(s):
Identify work and lessons learned under the four Regulatory Cooperation Council (RCC) initiatives on the electronic submission gateway, common monographs for over-the-counter drugs, good manufacturing practices and veterinary drugs.

Presentation(s) & Speaker(s):
Panelist
Louise Déry
Director, Policy, Planning and International Affairs Directorate
Health Canada, Canada

Panelist
Sema D. Hashemi, MSc
Office of International Programs, Office of the Commissioner
FDA, United States