JHTV invites you to a webinar focused on regulatory strategy. We teamed up with AstraZeneca’s Executive Regulatory Science Director Mohamed Jessa, Ph.D. who will present a thorough break down of the process. Attendees will learn how to avoid expensive errors and regulatory issues while developing and marketing products.
KEY QUESTIONS TO BE ADDRESSED:
- What defines the regulatory class of your product?
- How do your product specifications affect the regulatory class of your product?
- How claims for regulatory approval affect clinical strategy?
- How early in commercialization do you need to address regulatory issues?
- How far should you take your product toward regulatory approval?
Mohamed Jessa, Ph.D., Executive Regulatory Science Director, AstraZeneca
Dr. Jessa has been working in Regulatory Affairs since 1998, initially for Faulding Pharmaceuticals, and Serono before joining AstraZeneca in 2002. He has been the Global Regulatory Lead (GRL) for blockbuster medicines, gaining key worldwide approvals for these products. He has also been the GRL for numerous early development products, and responsible for health authority interactions and IND/CTA approvals. He is a registered Pharmacist gaining his degree from Leicester and a PhD from the University of Nottingham, both in the UK.