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Session 3: Reliance
Session Chair(s)
Fadila Lakkis
Regulatory Affairs, Intelligence & Communications Manager, Gulf
GSK, United Arab Emirates
Susanne Ausborn, PhD
Global Head International Regulatory Policy
Roche, Switzerland
Harmonisation of requirements towards global standards, convergence of regulatory processes and frameworks that allow the sharing of confidential information are foundational to support agencies’ collaboration across countries and regions. In addition, the speed of technology innovation is accelerating, and regulatory workload is increasing. To cope with this demand, regulators are implementing reliance pathways for different regulatory activities, such as initial applications, inspections, lab testing, post-approval changes and pharmacovigilance. Regulatory reliance has become a 21st-century regulatory science tool for more efficient decision-making and smarter use of regulatory resources. In this session, we will explore current global Reliance initiatives and how it is being implemented in the MENA region.
Speaker(s)
WHO Reliance Efforts
Luther Gwaza, PhD
World Health Organization (WHO), Switzerland
Team Lead-Pharmaceuticals Norms & Standards, Depart of Health Products Policy
Relying and being a Reference Agency as a Strategy to Bring Innovation - Good practices in making Reliance happen both ways to optimise resources
Agnes Chan
Health Sciences Authority Singapore, Singapore
Regulatory Consultant with the Pharmaceuticals & Biologics Branch
EMA Reliance Focus Group and EMA OPEN – regulators and industry perspective
Victoria Palmi-Reig
European Medicines Agency, Netherlands
International Affairs
EMA Reliance Focus Group and EMA OPEN – regulators and industry perspective
Angelika Joos, MPharm
MSD, Belgium
Executive Director, Global Regulatory Policy
Continental Reliance Framework - AMA Pilot Initiative & Evaluation Guidelines
Chimwemwe Chamdimba
African Union Development Agency-NEPAD, South Africa
African Medicines Regulation Harmonization Programme Head
Reliance is not a “one size fits all”. How is the principle being implemented?
Rana Malkawi
Jordan Food and Drug Administration (JFDA), Jordan
Drug Directorate Director
Panel Discussion with QandA, with the additional participation of:
Jacqueline Acquah
CEPI (Coalition for Epidemic Preparedness Innovations), Ghana
Regulatory Affairs _ Middle-East and Africa
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