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REGULATORY TRACK - Session 5: Improving Access to Innovation from a Regulatory Perspective
Session Chair(s)
Angelika Joos, MPharm
Executive Director, Global Regulatory Policy
MSD, Belgium
Collaboration between Regulatory Agencies across countries and regions is increasingly important to ensure medicines & vaccines are reaching patients as early as possible. This new way of working has been tested successfully during the COVID pandemic and the positive experience and added value of collaboration should now be taken forward. Underpinning the increased collaboration has been the building of trust between regulators of different countries as well as technical assistance.
In this session we will review how the establishment of specific twinning projects, reliance models and other cooperation mechanisms to increase convergence of standards and more regional collaboration could lead to improving access to innovation. We will also review specific examples that can be used to improve access to innovations and to guide further collaboration models.
Speaker(s)
PRIME and other tools to Accelerate Access to Innovation in the EU
Francesca Cerreta, PharmD, MPharm, MS
European Medicines Agency, Netherlands
Principal Scientific Officer
Bosnia & Herzegovina – Going from a Governmental body to a Regulatory body to improve Access to Innovation
Biljana Tubic, DrSc
Agency for Medicinal Products and Medical Devices (ALMBiH), Bosnia and Herzegovina
Deputy Agency Director for the Department for Medicinal Products for Human Use
Experience with National Scientific Advice
Danica Kontek, MPharm
HALMED Agency for medicinal products and medical devices, Croatia (Hrvatska)
Principal Coordinator for non-prescription Medicinal Products
Case study: Examples of Acceleration of Access to Innovation from a Regulatory Perspective
Sini Eskola, MPharm, MS, MSc
EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium
Director Regulatory Affairs
Panel Discussion and Q&A, with the additional participation of:
Samvel Azatyan, MD, PhD
World Health Organization (WHO), Switzerland
Team Lead, Regulatory Convergence and Networks (RCN/REG)
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