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Virtual

Mar 15, 2021 9:00 AM - Mar 19, 2021 4:30 PM

(Central Europe Standard Time)

DIA EUROPE 2021

Reliance: The Key to Smart Regulation?

Session Chair(s)

Petra  Doerr, PharmD, RPh

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)

Rogerio PAULO Gaspar, PharmD

Keynote

Rogerio PAULO Gaspar, PharmD

World Health Organization (WHO), Switzerland

Director, Regulation and Prequalification Department

Akthem   Fourati

Panelist

Akthem Fourati

UNICEF Supply Division, Denmark

Chief, Medicine & Nutrition Centre

Delese Mimi  Darko, MBA, RPh, RAC

Panelist

Delese Mimi Darko, MBA, RPh, RAC

Food and Drugs Authority, Ghana

Chief Executive Officer

Angelika  Joos, MPharm

Panelist

Angelika Joos, MPharm

MSD, Belgium

Executive Director, Global Regulatory Policy

Murray M. Lumpkin, DrMed, MD, MSc

Panelist

Murray M. Lumpkin, DrMed, MD, MSc

Bill and Melinda Gates Foundation, United States

Deputy Director, Integrated Development, Lead for Global Reg Systems Initiative

Ritu  Nalubola, PhD

Panelist

Ritu Nalubola, PhD

FDA, Belgium

Director, FDA Europe Office

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