[First Announcement] PMDA-ATC Pharmacovigilance Seminar 2018

August 28, 2017
Pharmaceuticals and Medical Devices Agency
 

Pharmaceuticals and Medical Devices Agency (PMDA) of Japan is pleased to announce its training program, the "PMDA-ATC Pharmacovigilance Seminar 2018."  This seminar, designed for regulatory authority officials who are engaged in pharmacovigilance activities, will be offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) at PMDA Office in Tokyo, on February 5-8, 2018.
 
The Seminar will cover wide range of topics on pharmacovigilance, including regulations, risk management, global safety data collection and labeling.
 

Date

February 5 to 8, 2018
 

Venue

Pharmaceuticals and Medical Devices Agency (PMDA)
Shin-kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
 

Seminar Organized By:

PMDA-ATC
 

This seminar is held as a workshop of the Asia-Pacific Economic Cooperation, Life Sciences Innovation Forum, Regulatory Harmonization Steering Committee (APEC-LSIF-RHSC) Centers of Excellence.
 

Program

• Pharmacovigilance regulatory systems in EU/US/Japan
• Regulation on Labeling in Asia/EU/US
• Risk Evaluation and Mitigation Strategy (REMS) / Elements to Assure Safe Use (ETASU)
• Risk Management Plan
• Safety Specifications and Pharmacovigilance Plan
• International Safety Data Collection
• Pharmacovigilance and epidemiology
• Benefit-Risk Assessment through product lifecycle
• Risk communication
• Relief Services for Adverse Health Effects

Registration

Registration for the seminar will be opened in October.
 

Contact Us

For more information, please contact:
Secretariat, PMDA Asia Training Center
E-mail: PMDA-ATC●pmda.go.jp
 
Office of International Cooperation
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan
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