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Strengthening of Regulatory Systems: How is it Achieved and When?
Session Chair(s)
Lembit Rago, DrMed, MD, PhD
Secretary General
Council for International Organizations of Medical Sciences (CIOMS), Switzerland
National competent authorities (NCAs) play a vital role in the health care system by providing regulatory oversight of all health medical products. Helping NCAs fulfil their mandate in an effective, efficient, predictable and transparent manner is therefore of critical importance in ensuring the quality, safety and efficacy of health products in an increasingly complex global environment. This session examines some of the key considerations and developments associated with building capacity and cooperative approaches to regulation, in line with the World Health Assembly (WHA) Resolution 67.20 on regulatory system strengthening for medical products.
Learning Objective : Getting arguments to answer the question if and how technology can be utilized as helpful tool facilitating the sharing of workload in Drug Regulatory Affairs. Understand the prerequisites how interoperability can be supported between multiple systems to be developed in the pharmaceutical regulated environment
Speaker(s)
Why is Regulatory System Strengthening Important?
Lembit Rago, DrMed, MD, PhD
Council for International Organizations of Medical Sciences (CIOMS), Switzerland
Secretary General
Telematics Goes Global – How Can Technology Strengthen Regulatory Systems?
Klaus Menges, DrMed
BfArM, Germany
Project Manager
The International Coalition of Medicines Regulatory Authorities (ICMRA) Role in Capacity Building: Where Are the Gaps and Overlaps?
Toshiyoshi Tominaga, PhD
Keio University Hospital, Japan
Project Professor
Regulating Medical Devices: Bridging Gaps on a Global Scale
Josee Hansen
World Health Organization, Switzerland
Senior Advisor
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