ComplianceOnline

Course Description:

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.



Learning Objective:

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
  • Marketing
  • Medical Affairs
  • Legal
  • Regulatory Compliance



Course Outline:

Day One (8.00AM – 4.00PM) Day Two (8.30AM – 4.00PM)
  1. Introduction to FDA Meetings
    1. The evolution of FDA Meetings
      1. 1970’s
      2. 1980’s
      3. 1990’s
      4. 2000’s
    2. What kind of FDA meetings are there.
      1. Drugs & Biologics – Pre Sub (IND, NDA)
      2. Devices – Pre-Sub (510(k), IDE, PMA)
      3. Compliance Issues
  2. FDA proposed Guidance Document of July 13, 2012
  3. "Draft Guidance for Industry and FDA Staff Medical Devices: The Pre-Submission Program and Meetings with FDA Staff”

  4. Preparing for an FDA Meetings
    1. Initial communication with FDA
    2. Preparing an agenda
    3. Rehearsing the meeting.
  5. Conducting the meeting at FDA
    1. Arrival time
    2. AV Needs
    3. Introductions
    4. FDA Comments
    5. Issues identified

  1. Conducting the meeting at FDA (continued)
  2. Conducting FDA Meetings – Role Playing Exercise
    1. Mock Pre-Sub IDE Meeting
    2. Mock Pre-Sub IND Meeting
    3. Mock Compliance Meeting
  3. Review of Successful/Unsuccessful FDA Meetings.
    1. Did the firm give a concise meaningful introduction?
    2. Were the questions appropriate for a response at the meeting?
    3. Did the firm accomplish their objectives?
  4. Future FDA Meetings for your product




Meet Your Instructor

Larry Stevens
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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Call here to register +1-888-717-2436 or email at customercare@complianceonline.com

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Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 200
Palo Alto, CA 94303
USA

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Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ editor@complianceonline.com

Payment:
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.

Testimonials

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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  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.


Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.







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