Maximizing Regulatory Health Authority Consultations: A Comprehensive Primer

Join us to learn how to make the most of your Regulatory Health Authority (HA) consultations! With long preparation lead-times, high costs, and resources required to prepare for and attend these consultations, it is critical to maximize your time. This presentation will provide insight into the different types of FDA and European Scientific Advice meetings and the logistical and strategic planning needed for each meeting.

• Learn how to structure your questions so you get the most information out of the meeting
• Hear case studies from consultations for traditional drugs and well-characterized biologics as well as advanced therapies such as gene and cellular therapies
• Understand the different focuses at meetings to discuss different clinical phases
• Learn why it is important to have written minutes from these meetings for future partnering activities

Presented by Clara Li, VP Regulatory & Strategic Development

Don’t miss this opportunity to learn how to make the most of your HA consultations!