The Conducting Successful FDA Meetings to Negotiate Product Development and Approval: 2-day In-person Seminar 2013 covers topics such as:
- How to prepare an FDA meeting request in accordance with recent FDA proposed guidelines
- The types of FDA meetings that FDA welcomes
- Types of FDA persons who conduct meetings with Industry
- The format and contents of a meeting request
- Preparing an agenda for the meeting
- Type of questions appropriate to ask FDA, and inappropriate to ask FDA
- How to prepare your team for the FDA meeting
- Who should attend the meeting representing your firm
- How to judge your success after the FDA meeting
- How to serve as the central spokesperson of your team at the FDA meeting
- Preparing a meeting summary for FDA
The Conducting Successful FDA Meetings to Negotiate Product Development and Approval: 2-day In-person Seminar 2013 brings together:
- Marketing
- Regulatory Affairs
- Legal
- Medical Affairs
- Regulatory Compliance