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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
Team Lead-Pharmaceuticals Norms & Standards, Depart of Health Products Policy, World Health Organization (WHO), Switzerland
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
Director, Therapeutic Products Branch, Health Sciences Authority, Singapore
EMA Reliance Focus Group and EMA OPEN – regulators and industry perspective
Victoria Palmi-Reig, MPharm
International Affairs, European Medicines Agency, Netherlands
EMA Reliance Focus Group and EMA OPEN – regulators and industry perspective
Angelika Joos, MPharm
Consultant, Consultant, Belgium
Continental Reliance Framework - AMA Pilot Initiative & Evaluation Guidelines
Chimwemwe Chamdimba
Principal Programme Officer-African Medicines Regulatory Harmonisation Program, African Union Development Agency-NEPAD, South Africa
EFPIA MERN-IFPMA ARN Survey on Reliance - Current Status of Reliance Implementation in the Region
Fadila Lakkis
Regulatory Affairs, Intelligence & Communications Manager, Gulf, GSK, United Arab Emirates
Reliance is not a “one size fits all”. How is the principle being implemented?
Rana Malkawi
Drug Directorate Director, Jordan Food and Drug Administration (JFDA), Jordan
Panel Discussion with QandA, with the additional participation of:
Jacqueline Acquah
Regulatory Affairs _ Middle-East and Africa, CEPI (Coalition for Epidemic Preparedness Innovations), Ghana
Panel Discussion with QandA, with the additional participation of:
Donia Albastaki
Acting Director, Pharmaceutical and Herbal Medicine Registration & Control Admin, Ministry of Health, State of Kuwait, Kuwait