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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)
Magda Bujar, PHD, MSC
Associate Director, Regulatory Programme and Strategic Partnerships, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Regulatory Risk-Based Approaches – Are These Enabling Better Availability and Access to Medicines Globally?
Jayanthi Boobalan, MBA, MPHARM, RPH
Head of Regional Regulatory Hub , Pfizer (Malaysia) Sdn. Bhd., Malaysia
Reliance in Action – Pfizer Vaccine Experience Case Study
Martin Harvey Allchurch, LLM
Head of International Affairs, European Medicines Agency, Netherlands
EMA Strive for Reliance
Isabelle Colmagne-Poulard, PHARMD, MBA, MSC
Head, International Global Regulatory & Scientific Policy, Merck, Switzerland
Driving for a Sustainable and Agile Reliance Process
Marko Eric
Regulatory Assessor, Medicines and Medical Devices Agency of Serbia , Serbia
Panelist
Nélio Cézar de Aquino, MSC
General Manager of Medicines, ANVISA, Brazil
Panelist
Chimwemwe Chamdimba
Principal Programme Officer-African Medicines Regulatory Harmonisation Program, African Union Development Agency-NEPAD, South Africa
Panelist
Hamada Sherief
Director of the General Administration of Registration of Pharmaceutical, EDA, Egypt
Panelist
Bandar Al Hammad, MPHARM
Chief Pharmacist & Director of Veterinary Products Department, Saudi Food and Drug Authority (SFDA), Saudi Arabia
Panelist
Samvel Azatyan, MD, PHD
Senior Adviser, Council For International Organizations of Medical Sciences (CIOMS), Switzerland
Panelist
Reem Al-Naimat
Consultant Pharmacist, Head of Manufacturing Sites Accreditation Unit, Jordan Food and Drug Administration (JFDA) , Jordan
Panelist
Sabina Uzeirbegovic, MPHARM
Principal Regulatory Affairs Advisor, HALMED, Croatia
Panelist
Susanne Ausborn, PHD
Global Head International Regulatory Policy, Roche, Switzerland
Take 5 and Closing
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