This seminar (webinar) is intended to help those in pharmaceutical and medical device industry involved in interacting and communicating with the health authorities. In particular, this seminar will discuss best practices for communicating, interacting and negotiating with FDA reviewers before and during the review process.
In this 60-min presentation, the speaker will guide you through the details of what is best in exercising your judgement and discretion while communicating and interacting with the FDA reviewers.
- FD&C Act and its implementing regulations
- FDA reviewer’s duties and responsibilities
- Types and characteristics of FDA reviewers
- Working with (in)experienced reviewers: issues, challenges and solutions
- Applying emotional intelligence and negotiation skills
- Dealing with changing scope of information request
- Dealing with when the reviewer is not making his/her position clear
- Understanding and analyzing an FDA reviewer’s position: views and comments
- Responding to the FDA reviewer’s questions and additional information
- Handling when interaction and communication are not going anywhere
- Dealing with when retaliatory actions by the reviewer are perceived
- Draft guidance, issued March 5, 2013, entitled “Types of Communication During the Review of Medical Device Submissions.”
- Practical, actionable, and sustainable strategies/solutions
Dr David Lim,
President and Principal Consultant ,
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.