17 May 2016
5:30–9:00 pm
Bridgewater Manor
Bridgewater, NJ
Whether you have or you haven’t been to an Advisory Committee or Device Panel meeting, this session critiquing video footage of actual meetings to evaluate the performance of the sponsor, the actions of the panel and the role of the FDA is a can’t miss. Get a play-by-play on the format, setting and audience of a meeting and leave with an increased understanding of what you can expect from an AdCom or Panel Meeting, and how you can prepare your team to win.
Learning Objectives:
- Understand the process leading up to a panel meeting, for both the Sponsor and FDA
- Identify key project activities that can be strengthened by incorporation of panel considerations during both the IDE and PMA
- Strategize opportunities for improving the chances of success for your panel-track project
This meeting is sponsored by the RAPS New York/New Jersey Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals. A dinner buffet will be available to all meeting participants. Attendees who hold the RAC may claim two RAC recertification credits.
Date/Time:
Tuesday, 17 May 2016
5:30–6:30 pm Registration Check-in, Networking and Dinner
6:30–8:30 pm Speaker Presentation
8:30–9:00 pm Q&A Session
Location:
Bridgewater Manor
1251 Routes 202 and 206
Bridgewater, NJ 08807
Get directions online or call +1 908 658 3000
Registration:
Prior to 12 May
RAPS Members: $70 Nonmembers: $85
On or after 12 May
RAPS Members: $80 Nonmembers: $95
» Registration Form (PDF) - for registration by mail or fax, or call +1 301 770 2920 ext. 200.
Speakers:
Penny Daniels is a strategic communications consultant and coach for pharmaceutical and device companies, academic institutions, government, and non-profits, empowering top executives and scientists to communicate effectively in urgent, high-pressure environments. An accomplished writer, Penny is recognized for her ability to quickly distill essential messages from complex data, assisting individuals and teams in developing presentations, speeches, webcasts and other content. Penny excels in helping communicators optimize their own individual styles to meet audience needs and achieve business and organizational goals. A former national broadcast journalist, Penny uses her experience to make even the most senior executives comfortable with the coaching process and draw the best performances from the most reluctant presenters. Penny helps communicators succeed at challenging FDA advisory committee meetings and scientific conferences, present to critical internal audiences and develop and deliver important messages to an increasingly skeptical press.
Cindy DiBiasi has built a reputation as a leading health care communications consultant by working with top executives at some of the world's largest companies. Her approach is rooted in the belief that even the most daunting communications challenges provide opportunities for companies and executives to define themselves and convey important information to regulatory and government officials, customers, colleagues, shareholders and the public. DiBiasi’s work ranges from helping clients identify their communications strategy and develop messages on controversial healthcare issues to leading them through high-stakes FDA meetings and advisory committee hearings. Her consulting, writing and coaching work also include: preparing clients for product launch and commercialization issues, public presentations, quarterly earnings calls and media interviews. DiBiasi began her media career as a broadcast reporter in the United States and Europe. She was also the medical reporter for the CBS affiliate in Washington, DC, where, as part of her responsibilities, she covered the FDA.
Local Contact:
Linda Bowen, RAC, FRAPS,RAPS NY/NJ Chapter Chair
RAPS Contact:
Wesley Carr, senior manager of chapter and account relations, RAPS, +1 301 770 2920