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Session 1 / Venue 3: New Initiative at the International Community ~ (English Language Only)
Session Chair(s)
Nobumasa Nakashima
Health Policy Director, National Healthcare Policy Secretariat
Cabinet Office, Japan
ICH is one of the most representative bodies of international cooperation in the pharmaceutical area. One of the purposes of ICH is the international harmonization of guidelines on new drugs and their activities and accomplishments are highly acclaimed. Addition to ICH activities, various international cooperation has recently launched globally and regionally in a wide range of topics such as generic drugs and general regulatory affairs. Among these new initiatives, there are organizations whose outcomes have already been organized or soon to be and their activities attract close attention from affiliates. IPRF (International Pharmaceutical Regulatory Forum) in the scope of general pharmaceutical regulations, IGDRP (International Generic Drug Regulatory Pilot) in generic drugs, and US-Canada cooperation and PAHO in regional cooperation are some of the examples of those activities. In this session, speakers who play central roles in those new initiatives will introduce their current activities, future plans, and the effects on pharmaceutical companies. Discussion time is held at the end of the session.
Speaker(s)
ASEAN Activities and International Cooperation (tentative)
Yuppadee Javroongrit, PhD
Food and Drug Administration, MOPH, Thailand
Senior Expert in Pharmaceuticals Standard
Recent Tends of International Cooperation: US-Canada Regulatory Cooperation Council a Concrete Example of Regulatory Alignment Collaboration
Louise Déry
Health Canada, Canada
Director, Policy, Planning and International Affairs Directorate
ANVISA’s International Activities
Patricia Oliveira Pereira Tagliari, LLM, MPH
ANVISA, Brazil
Associate Director
Generic Initiative: IGDRP (tentative)
Mike Ward
World Health Organization (WHO), Switzerland
Coordinator, Regulatory Systems Strengthening, EMP
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