At the US Food and Drug Administration (FDA), there are various types of professionals with differing background in diverse areas of laws, medicines, physics, biology, chemistry, engineering, etc. To effectively navigate the regulatory process, it becomes important to understand how to effectively communicate and interact with FDA reviewers.
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.
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.
In this 60-min presentation, the speaker will guide you through the details of how to implement the systematic and holistic risk management for drugs, biosimilars, biologics and medical devices.
Areas to be Covered:
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
Effectively applying recent FDA guidance
Practical, actionable, and sustainable strategies/solutions
Best practices: PASS-IT recommendations
Who will Benefit:
Managers (RA, QA/QC, CA)
Contractors and Subcontractors
Anyone interested in the topic