Conducting Successful FDA Meetings to Negotiate Product Development and Approval
Larry Stevens, RAC Principal Consultant, One Way Consultants, LLC, FDA Regulatory Expert
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This interactive two-day course will cover all types of FDA meetings, reasons and requirements. It will help you to prepare an FDA meeting request in accordance with recent FDA proposed guidelines.
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 recently formalized this meeting process and this course will help prepare you to handle the new FDA requirements for meetings, and conduct successful meetings.
How will this benefit your company? FDA meetings can be a critical factor in the timeliness of FDA review and approval. It allows the firm to pose critical questions for FDA and gain more understanding of FDA expectations. In addition, a face to face meeting allows the firm to establish an identity with FDA reviewers that can greatly assist future communications.
What can happen if you are not familiar with FDA meeting reasons and requirements? You may not meet with FDA when a meeting is prudent and necessary or even worse, meet with FDA and have the meeting go badly because you were not properly prepared.
Key goals of the conference will include learning:
- Become familiar with the types of FDA meetings that FDA welcomes.
- Know how to prepare an FDA meeting request in accordance with recent FDA proposed guidelines.
- Know the format and contents of a meeting request.
- 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.
- 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.
Who will Benefit:
Senior executives, directors, managers and those who have responsibility for developing new products and gaining FDA approval, as well as those that have key collateral roles in reviewing and/or preparing FDA submission documentation for drug and device firms, including officials from these areas within regulated companies:
- Regulatory Affairs
- Medical Affairs
- Regulatory Compliance
|Day One (8.00AM – 4.00PM)
||Day Two (8.30AM – 4.00PM)
- Introduction to FDA Meetings
- The evolution of FDA Meetings
- What kind of FDA meetings are there.
- Drugs & Biologics – Pre Sub (IND, NDA)
- Devices – Pre-Sub (510(k), IDE, PMA)
- Compliance Issues
- FDA proposed Guidance Document of July 13, 2012
"Draft Guidance for Industry and FDA Staff Medical Devices: The Pre-Submission Program and Meetings with FDA Staff”
- Preparing for an FDA Meetings
- Initial communication with FDA
- Preparing an agenda
- Rehearsing the meeting.
- Conducting the meeting at FDA
- Arrival time
- AV Needs
- FDA Comments
- Issues identified
- Conducting the meeting at FDA (continued)
- Conducting FDA Meetings – Role Playing Exercise
- Mock Pre-Sub IDE Meeting
- Mock Pre-Sub IND Meeting
- Mock Compliance Meeting
- Review of Successful/Unsuccessful FDA Meetings.
- Did the firm give a concise meaningful introduction?
- Were the questions appropriate for a response at the meeting?
- Did the firm accomplish their objectives?
- Future FDA Meetings for your product
Meet Your Instructor
RAC Principal Consultant, One Way Consultants, LLC, FDA Regulatory Expert
Larry is a professional speaker who can train persons on all aspects of FDA requirements, and practical and successful solutions to FDA problems. He 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, he was the Industry Representative on the FDA Circulatory Systems panel. 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.
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I really enjoyed the interactive nature of this event and learned a great deal of insight from the instructor and the other participants. It provided good insight into how the FDA thinks and makes decisions. ComplianceOnline provides important information to busy professionals who lack time to seek it out by themselves.
- Senior QA Technical Specialist, FUJIFILM Diosynth Biotechnologies U.S.A., Inc
This seminar was incredibly informative. The mock FDA meetings were very useful and learned a lot from real life experiences.
- Manager, Regulatory Affairs, Dow Pharmaceutical Sciences
I was strongly encouraged by this meeting. Larry is an excellent and dynamic speaker. It was great to know good and reasonable attitude of the FDA.
- Professor, Sanford-Burnham Medical Research Institute
Larry has exceptional skills and practical experiences. This training provided me with an excellent insight into FDA meetings.
- Manager, Regulatory Affairs, Moog Medical Devices Group
Larry is very knowledgeable and is an excellent speaker. Topics related to pre-IDE meetings were highly informative and useful for me. The anecdotes and the real world examples made this seminar very interesting and created a great atmosphere as well.
- Head of Clinical Operations, Molnlycke Health Care AB
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