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REGULATORY TRACK - Session 3: Increasing Stakeholder Dialogue across Countries and Regions: Regulatory Flexibility and Agilities during the COVID-19 Pandemic
Session Chair(s)
Melly Lin
CMC Regulatory Policy Lead, Pharma Technical Regulatory
F. Hoffmann-La Roche Ltd, Switzerland
The COVID-19 pandemic is the public health challenge of our time. It has required significant acceleration to normal development timelines across therapeutics, vaccines and diagnostic tools. The pandemic has equally driven the implementation of greater regulatory flexibility to allow manufacturers to bring the innovative treatments to patients globally and to make the necessary changes to facilities and manufacturing processes to ensure adequate supply of quality medicines.
In this session, we will share lessons learned from COVID-19, especially around the regulatory landscape and scientific tools to accelerate patient access and ensure continuous supply of quality medicines to patients. We will discuss how the new normal looks like, what will be sustained and where do we go next. Additionally, we will discuss how the different stakeholders can collaborate in driving agilities.
Speaker(s)
Regulatory Flexibility and Agilities during the COVID-19 Pandemic in the EU
Martin Harvey Allchurch, LLM
European Medicines Agency, Netherlands
Head of International Affairs
Best Practices in the approval of COVID Therapies
Jadranka Mirkovic
Medicines and Medical Devices Agency of Serbia (ALIMS), Serbia
Head of the Humane Medicines Centre
Bosnia & Herzegovina’s Experience
Amar Elezovic, MPharm
Agency for Medicinal Products and Medical Devices (ALMBiH), Bosnia and Herzegovina
Montenegro’s Experience
Mira Kontic
Institute for Medicines and Medical Devices, Montenegro
Deputy Managing Director
North Macedonia’s Experience
Aleksandra Grozdanova, PharmD
National Coordinator For Immunization, North Macedonia
Professor, Faculty of Pharmacy, Skopje
Industry’s perspective on Regulatory Flexibility and Agilities during the COVID-19 Pandemic: Recommendations
Jinesh Patel, PhD, MS, RPh
Vertex Pharmaceuticals, United Kingdom
Associate Director, Regulatory Strategy
The Patient’s Perspective
Milan Miskovic
North Macedonia
Panel Discussion and Q&A, with the additional participation of:
Ranela Ceci, PhD
National Agency For Medicinal Products and Medical Devices (AKBPM), Albania
Specialist, Marketing Authorization and Regulatory Affairs Department
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