Good Meeting Practices for Conducting Successful FDA Meetings
Mr. Stevens has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for a cardiovascular device. He currently serves as an expert witness for cases involving FDA regulatory compliance for medical devices. He regularly performs webinars regarding FDA and issues regarding clinical studies and medical devices. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public.
This webinar will familiarize you with the unique aspects of a meeting with FDA. This webinar will help prepare you to handle the FDA requirements for meetings, and how to conduct successful meetings.
Communicating with FDA to determine as much a possible about their expectations regarding product submissions, clinical study design, and other regulatory requirements is a challenge for every regulated business, but critical for drug and device firms. FDA has formalized this meeting process and this webinar will prepare you for the FDA meeting.
Too often firms approach FDA for a meeting and then expect the meeting to be like other meetings they participate in regularly. When they participate in the FDA meeting they many times are unprepared and get on the job training at the expense of their firm. We will discuss the differences in FDA meetings, how to prepare an agenda for the meeting, who to bring to the meeting, and what to expect from FDA.
This webinar is a must for any pharmaceutical or medical device firm that will encounter FDA meetings as part of their regulatory compliance efforts.
Virtually every medical device firm and pharmaceutical firm will need to meet with FDA as some time. To be prepared for these meetings and know how to handle them can be critical to the success of your business.
- Become familiar with the types of FDA persons who conduct meetings with Industry
- Know the type of questions appropriate to ask FDA, and inappropriate to ask FDA
- Preparing an agenda for the meeting
- Know who should attend the meeting representing your firm
- How to prepare your team for the FDA meeting
- How to serve as the central spokesperson of your team at the FDA meeting
- How to judge your success after the FDA meeting
- Preparing a meeting summary for FDA
Course Level - Intermediate and Advanced
Who Should Attend
- Medical Device and Pharmaceutic Senior Executives
- VP, Directors, and Managers of Regulatory Affairs
- VP, Directors, and Managers of Quality Assurance
- VP, Directors, and Managers of Clinical Affairs
- VP, Directors, and Managers R&D Engineers and Management
- Consultants to the medical device and pharmaceutical industry
Why Should Attend
If you are responsible for FDA relationships for your firm, and you have needs to meet with FDA regarding product development plans, clinical study design or compliance problems (Warning Letters), you cannot afford to have an unsuccessful FDA meeting. You must need to know how to plan and execute an FDA meeting to assure your company obtains the outcome that best serves the company’s needs.
- Speaker: J. LAWRENCE STEVENS
- Webinar Code: LAWR-0001