This session will focus on the preparation of a pre-IND Meeting Package for 505(b)(2) product development, and will feature one speaker (Aloka Srinivasan) that participated in SAAMnow’s successful workshop on Demystifying 505(b)(2) Development: Navigating the Scientific, Regulatory, Legal, and Business Complexities (October 16-18, 2019, Philadelphia, PA) and one speaker (Candis Edwards) from the pharmaceutical industry. The workshop highlighted the diversity, simplicity and complexity of the 505(b)(2) application process, and via these webinars we want to continue to fill the basic educational gap in understanding and characterizing the 505(b)(2) pathway by giving participants an opportunity to learn from experts in this field.
Webinar Session 5: Secrets to successful pre-IND meetings for 505(b)(2) NDA drug development
When: Friday, March 26th |11:00 am EDT (Eastern US)|Duration: 120 minutes
Presenter 1:
Aloka Srinivasan, Ph.D., Principal and Managing Partner, RAAHA LLC: To “b2” or not to “b2”: Importance of pre-IND meetings in determination of the pathway for an application
Areas Covered:
This presentation will provide an overview of PDUFA Formal Meetings including the following:
Presenter 2:
Candis Edwards, Senior Vice President Regulatory Affairs, Amneal Pharmaceuticals: Preparation for, attendance at, and follow-up of Pre-IND meetings for 5050(b)(2) NDA drug development
This presentation will provide details on the following steps for a successful pre-IND meeting:
We look forward to having you join us for our upcoming webinar. Topics under consideration for future SAAMnow webinars: