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Validity : 21st Apr'24 to 01st May'24
Conducting Successful FDA Meetings
- 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
Overview of the webinar
This 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.
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.
This 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.
Who should attend?
Senior 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
Why should you attend?
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.
Faculty - Ms.Marie Dorat
Marie Dorat, CQA, CAA is a QA/RA compliance, GxP Training and International product registration Consultant with 15 years experience in the Pharmaceutical/Medical Device & IVD Industry She also is the CEO of IPRF, LLC which specializes in helping established and start-up companies process the necessary documents for international product distribution. She is also Managing Partner at iComplyRegs, LLC which provides the most current FDA/EU/ROW regulatory requirements updates as well as experienced RA/QA Consultants