16 April - 15:00 -16:00 BST / 16:00 – 17:00 CET

Insights into Scientific Advice in Europe from an ex-CHMP and SAWP Member 
 
Synopsis
This webinar will offer a unique opportunity to understand key considerations when seeking Scientific Advice in Europe such as Assessors’ expectations of the briefing package, and optimal timing and approach to national Agencies versus the European Medicines Agency. In this interactive session, Dr Gonzalo Calvo, a former CHMP member for Spain, and Clinical Assessor at the Spanish Agency, will share his insights and some “do’s and don’ts” when engaging with regulatory Authorities in Europe. Participants will be able submit questions during the webinar. 
 
Learning outcomes (why attend)
• Understand key differences between Scientific Advice at EMA versus National Competent Authorities 
• Maximise outcomes from your Scientific Advice interactions at EMA and National Competent Authorities 
• Learn about the real expectations of the Assessor and how to make your Scientific Advice package review-ready
 
Target audience
Regulatory and drug development professionals wanting to learn more about engagement with regulatory Authorities in Europe for Scientific Advice
 
Speakers
• Dr Gonzalo Calvo was CHMP member for Spain and Clinical Assessor at AEMPS for 10 years. Together with CHMP colleagues, he had responsibility for all decisions pertaining to new drug MAAs in the European Union. Dr Calvo has held various other clinical and regulatory roles, including in pharmacovigilance. During his tenure at CHMP and AEMPS, he chaired and participated in a number of EMA / CHMP working parties, set up the Scientific Advice function at AEMPS, and assessed Scientific Advice Applications at EMA and AEMPS. Dr Calvo has broad experience advising pharma and biotech companies on regulatory and clinical development matters. He is Senior Regulatory & Medical Advisor at Kinesys and a member of our EMA Solutions Advisory Board. He is also currently Head of the Clinical Pharmacology Department at the Hospital Clinic, Barcelona.
 
• Dr Delphine Wagner has over 15 years’ experience working in Global Regulatory Affairs. At Kinesys, she provides regulatory expertise and leadership to clients on a range of projects including regulatory applications in Europe, US and EU National Competent Authorities and advises clients on regulatory strategy for early to late-stage development assets. Delphine has experience in leading teams in executing regulatory submissions and regularly engages with Agencies. Delphine has a PhD in Medicinal Chemistry from the University of Bath and has held post-doctoral research positions at Sanofi-Aventis and at the University of Oxford.
 
• 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. 

Disclaimer: Whilst TOPRA is running this webinar for Kinesys this is not an endorsement of Kinesys, KInesys'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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Pricing

• Members: free
• Non-members: free

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