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SESSION 2: WAY FORWARD - GOOD REGULATORY PRACTICE’S ROLE IN ACCELERATING PATIENTS ACCESS TO MEDICINES
Session Chair(s)
Nevena Miletic
IFPMA ARN Chair Advisor and Regulatory Policy & Science Chapter Leader
F. Hoffmann-La Roche Ltd, Switzerland
Regulators worldwide are developing various pathways to support speeding up drug development and accelerating access to medicines. There are new initiatives arising across the globe, including also development of new WHO guidance and recommendations. Reliance and work-sharing among regulators is heavily encouraged, allowing at the same time their resources and efforts to focus on other important areas in public health that cannot be streamlined.
This session will explore recent developments in the global regulatory landscape, emphasizing on the need for establishing appropriate regulatory pathways for accelerating access to innovation, as well as provide insights into specific region’s/countries’ experiences.
Speaker(s)
Industry perspective on Reliance & Expedited Pathways in Emerging Markets
Fabio Bisordi, MSc
F. Hoffmann-La Roche Ltd, Switzerland
Global Head International Regulatory Policy
Global Update on Good Regulatory Practices with the Focus on Facilitated Regulatory Pathways
Samvel Azatyan, MD, PhD
World Health Organization (WHO), Switzerland
Team Lead, Regulatory Convergence and Networks (RCN/REG)
Continental Progress Update on African Medicines Regulatory Harmonization
Paul Kiptum Tanui, MBA, RPh
The New Partnership For Africa's Development (NEPAD), South Africa
Senior Programme Officer, African Medicines Regulatory Harmonization Programme
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