Best Practices for Communicating and Interacting with FDA Reviewers

$299.00

Description:

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:

CEOs
VPs
Regulatory Affairs
Compliance Officers
Attorneys
Complainant Managers
Managers (RA, QA/QC, CA)
Consultants
Contractors and Subcontractors
Anyone interested in the topic

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, 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 eight 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 pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

$299.00

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance