4 December - 15:00 - 16:00 GMT / 16:00 – 17:00 CET
Joint Scientific Consultation: The balancing act of preparation across regulatory and market access
Covering the general requirements and eligibility for Joint Scientific Consultation, which topics are covered - from a regulatory and market access perspective; how to prepare from an operational (such as briefing book) and strategic (commercial and strategic implications) perspective
Learning outcomes: When should JSC be considered - from a regulatory and market access perspective and what it takes to prepare and when to consider alternatives.
Speakers:
Susanne Michel: Former Department of Health Berlin and Department of Health England, executed several Joint Scientific Advice procedures from a market access perspective
Graeme Deuchar: Dr Graeme Deuchar, a biomedical research professional, has over 10 years’ experience in regulatory affairs consultancy. He has significant experience in leading teams across a range of regulatory applications supporting the development of medicinal products for major global markets. His expertise also involves contributing to the regulatory strategy for product development in multiple therapeutic areas and he regularly engages with Regulatory Agencies. Graeme has a PhD in Cardiovascular Pharmacology from the Faculty of Medicine at the University of Glasgow, has held various academic positions in biomedical research and was co-founder and Research Director of Aurum Biosciences, a start-up biopharmaceutical company.
This webinar is sponsored by Clinigen
Disclaimer: Whilst TOPRA is running this webinar for Clinigen, this is not an endorsement of Clinigen, Clinigen's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.
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