Expedited regulatory pathways: strategies for an optimised path to approval

If you're seeking practical guidance on how to speed development and strengthen your regulatory approach, our latest webinar on, 'Expedited regulatory pathways: strategies for an optimised path to approval' will help you move faster with greater regulatory confidence.

Replay the webinar at your convenience and get insights on:

• How to leverage FDA and global expedited programmes to shorten development cycle
• Best practices for aligning early with regulators
• Strategies to strengthen submission packages for faster review
• Practical steps to reduce risk and improve approval outcomes

About the speakers:

Bruno Flamion, MD, PhD is a consultant in regulatory affairs and drug development strategy with clinical experience in internal medicine and nephrology. He worked for the European Medicines Agency (EMA) for 12 years as a member of the Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) representing Belgium.

Patricia Carlos has over 25 years of experience in the biotech and pharmaceutical industry, with a proven track record of success in driving global strategy, regulatory affairs, and strategic partnerships. Her expertise spans early development through approval and post-marketing in multiple therapeutic areas.

Delphine Wagner, PhD has over 15 years of experience working in Global Regulatory Affairs. At Clinigen, she provides regulatory expertise and leadership to clients across a range of projects, including regulatory applications in Europe, the US and at EU National Competent Authorities and advises clients on regulatory strategy for early to late-stage development assets.

Gerry McGettigan has over 30 years' experience in the biotechnology and pharmaceutical industries, in regulatory affairs, clinical development and business development, as well as in various non-executive director roles. Gerry founded the European regulatory affairs and product development consultancy company, GMG BioBusiness Ltd, which was acquired by a top-five CRO in 2005.