The FDA has published guidance regarding the types of meetings that will generally be granted and the information needed to conduct the meeting. However, the guidance tend to be general and interpreted in multiple ways. This topic will provide practical examples and suggestions for standard meetings as well as requesting and conducting non-typical meetings (such as during fast track, clinical hold, or for breakthrough therapy topics).
Rehearsal, post-meeting follow-up, and documenting nonformal FDA interactions will also be discussed in detail.
Why You Should Attend:
Obtaining feedback from the FDA at various times during the development process is crucial to the company to ensure that resources are not wasted and alignment is achieved. This session will provide you with the information you need to request, prepare for and conduct meetings with the FDA to maximize successful outcomes and receive actionable direction and information.
Areas Covered in the Session :
- Standard FDA Meeting Types and Timing
- General Qualifying Requirements
- Preparing the Meeting Request
- Preparing the Briefing Document
- Rehearsing for the Meeting
- Conduct of the Meeting
- Post-Meeting follow up
- Non-typical FDA meetings
- Preparation for non-typical meetings
- Documenting Informal meetings and correspondence
- Reference to meetings during future submissions
Who Should Attend:
- Regulatory Affairs Departments
- Quality Departments
- Compliance Departments
- Program Management Teams
- Project Management Teams
- Manufacturing Departments
- Everyone who may contribute to or participate in an FDA meeting
Course Director: PEGGY J BERRY
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).
She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).