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Conrad Cairo Hotel

Nov 25, 2024 6:00 PM - Nov 27, 2024 6:00 PM

1191 Nile Corniche, Cairo, 11221, Egypt

Middle East and North Africa Conference (MENA)

This two-day conference is designed for the industry's regulatory professionals to explore the evolving pharmaceutical landscape in the MENA region and address its unique challenges, with all regional regulators present.

Session 3: Reliance

Session Chair(s)

Fadila  Lakkis

Fadila Lakkis

Regulatory Affairs, Intelligence & Communications Manager, Gulf

GSK, United Arab Emirates

Susanne  Ausborn, PhD

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)

Luther  Gwaza, PhD

WHO Reliance Efforts

Luther Gwaza, PhD

World Health Organization (WHO), Switzerland

Team Lead-Pharmaceuticals Norms & Standards, Depart of Health Products Policy

Agnes  Chan

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

Director, Therapeutic Products Branch

Victoria  Palmi-Reig

EMA Reliance Focus Group and EMA OPEN – regulators and industry perspective

Victoria Palmi-Reig

European Medicines Agency, Netherlands

International Affairs

Angelika  Joos, MPharm

EMA Reliance Focus Group and EMA OPEN – regulators and industry perspective

Angelika Joos, MPharm

MSD, Belgium

Executive Director, Global Regulatory Policy

Chimwemwe  Chamdimba

Continental Reliance Framework - AMA Pilot Initiative & Evaluation Guidelines

Chimwemwe Chamdimba

African Union Development Agency-NEPAD, South Africa

African Medicines Regulation Harmonization Programme Head

Fadila  Lakkis

EFPIA MERN-IFPMA ARN Survey on Reliance - Current Status of Reliance Implementation in the Region

Fadila Lakkis

GSK, United Arab Emirates

Regulatory Affairs, Intelligence & Communications Manager, Gulf

Rana  Malkawi

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

Jacqueline  Acquah

Panel Discussion with QandA, with the additional participation of:

Jacqueline Acquah

CEPI (Coalition for Epidemic Preparedness Innovations), Ghana

Regulatory Affairs _ Middle-East and Africa

Donia  Albastaki

Panel Discussion with QandA, with the additional participation of:

Donia Albastaki

Drug and Food Control, Ministry of Health, Kuwait

Head of Drug Registration Department

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