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Reliance: The Key to Smart Regulation?
Session Chair(s)
Petra Doerr, PharmD, RPh
Director
European Directorate for the Quality of Medicines and Healthcare (EDQM), France
The WHO efforts on implementing the World Health Assembly Resolution on Strengthening of Regulatory Systems are showing results. But still many regulators in low- and middle-income countries have not reached a maturity level yet, which would be equivalent to a stable, well-functioning and integrated regulatory system. It is becoming more and more obvious that activities to build capacity need to be complemented with approaches to rely on work that has been performed by reference regulatory authorities. This applies to all regulators – not only to low-resourced ones. In fact, such approaches are far more common today among the moderately to well-resourced regulators. In order to increase the acceptance and implementation of reliance models, WHO is working on “Good Reliance Practices” and a framework for “WHO-listed Authorities” (WLAs) authorities upon which others can rely. The session will provide an overview of the ongoing work and an outlook towards future implementation and will also touch on aspects around the application of reliance in the context of a pandemic.
Speaker(s)
Keynote
Rogerio PAULO Gaspar, PharmD
World Health Organization (WHO), Switzerland
Director, Regulation and Prequalification Department
Panelist
Akthem Fourati
UNICEF Supply Division, Denmark
Chief, Medicine & Nutrition Centre
Panelist
Delese Mimi Darko, MBA, RPh, RAC
Food and Drugs Authority, Ghana
Chief Executive Officer
Panelist
Angelika Joos, MPharm
MSD, Belgium
Executive Director, Global Regulatory Policy
Panelist
Murray M. Lumpkin, DrMed, MD, MSc
Bill and Melinda Gates Foundation, United States
Deputy Director, Integrated Development, Lead for Global Reg Systems Initiative
Panelist
Ritu Nalubola, PhD
FDA, Belgium
Director, FDA Europe Office
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