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Thrive Through Reliance Implementation
Session Chair(s)
Susanne Ausborn, PhD
Global Head International Regulatory Policy
Roche, Switzerland
Martin Harvey Allchurch, LLM
Head of International Affairs
European Medicines Agency, Netherlands
The session will bring together regulators from different parts of the world, EMA and industry experts will reflect on the current implementation status of reliance pathways. While it is broadly acknowledged that reliance is at the core of a more efficient use of global resources, there are still many challenges?delaying or preventing its broader use. Based on recent data collected by CIRS, concrete example and?surveys from industry we will discuss ?ongoing efforts to bring reliance into action and present different reliance tools currently used by regulators from different jurisdictions with the goal to streamline approvals and ultimately access to patients.? At the same time we will address other critical topics like product sameness and diverging country specific requirements which are crucial when applying reliance and moving towards one global regulatory standard.
Learning Objective : • Discuss how collaborative models are implemented into regulatory frameworks for the registration of medicines, including best practices • Review global trends, challenges and opportunities in ensuring efficient, effective and sustainable systems in as well as regulatory convergence • Consider lessons learned from the pandemic and what should remain to enable global availability of medicines
Speaker(s)
Regulatory Risk-Based Approaches – Are These Enabling Better Availability and Access to Medicines Globally?
Magda Bujar, PhD, MSc
Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Senior Manager, Regulatory Programme and Strategic Partnerships
Reliance in Action – Pfizer Vaccine Experience Case Study
Jayanthi Boobalan, MBA, MPharm, RPh
Pfizer (Malaysia) Sdn. Bhd., Malaysia
Head of Regional Regulatory Hub
EMA Strive for Reliance
Martin Harvey Allchurch, LLM
European Medicines Agency, Netherlands
Head of International Affairs
Driving for a Sustainable and Agile Reliance Process
Isabelle Colmagne-Poulard, PharmD, MBA, MSc
Merck, Switzerland
Head, International Global Regulatory & Scientific Policy
Panelist
Marko Eric
Medicines and Medical Devices Agency of Serbia , Serbia
Pharmacovigilance Assessor
Panelist
Nélio Cézar de Aquino, MSc
ANVISA, Brazil
General Manager of Medicines
Panelist
Chimwemwe Chamdimba
African Union Development Agency-NEPAD, South Africa
African Medicines Regulation Harmonization Programme Head
Panelist
Hamada Sherief
EDA, Egypt
Director of the General Administration of Registration of Pharmaceutical
Panelist
Bandar Al Hammad, MPharm
Saudi Food and Drug Authority (SFDA), Saudi Arabia
Chief Pharmacist, Regulatory Affairs Department
Panelist
Samvel Azatyan, MD, PhD
World Health Organization (WHO), Switzerland
Team Lead, Regulatory Convergence and Networks (RCN/REG)
Panelist
Reem Al-Naimat
Jordan Food and Drug Administration (JFDA) , Jordan
Consultant Pharmacist, Head of Manufacturing Sites Accreditation Unit
Panelist
Sabina Uzeirbegovic, MPharm
HALMED, Croatia (Hrvatska)
Principal Regulatory Affairs Advisor
Take 5 and Closing
Susanne Ausborn, PhD
Roche, Switzerland
Global Head International Regulatory Policy
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