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Boston Convention and Exhibition Center

Jun 23, 2013 8:30 AM - Jun 27, 2013 12:45 PM

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

Challenges for Stable Supply of Drugs and International Cooperation

Session Chair(s)

Nobumasa  Nakashima

Nobumasa Nakashima

Health Policy Director, National Healthcare Policy Secretariat

Cabinet Office, Japan

FDA, EMA and PMDA representatives will explain the current issues and measures against drug shortages in the rapid globalization of supply chains. They will also suggest a cooperative scheme among regulatory authorities and industries to secure a stable supply of drugs.

Learning Objective : Describe the current drug supply situation in the US, Europe and Japan and the efforts made by regulators and manufacturers; Discuss possible global cooperation for a stable supply of drugs including shortage information sharing and recommendations to manufacturers.

Speaker(s)

Justina  Molzon, JD, MS

FDA Perspective

Justina Molzon, JD, MS

Consumer Services, United States

Consumer Services

Emer  Cooke, MBA, MSc

EMA Perspective

Emer Cooke, MBA, MSc

The European Medicines Agency, Netherlands

Executive Director, Chair, ICMRA

Naoyuki  Yasuda, MSc

Japan Perspective

Naoyuki Yasuda, MSc

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Associate Executive Director , Office of International Programs

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