- Date: September 12, 2019
- This seminar recurs tri-monthly on second Thursdays.
- Time: 08:00 AM PST | 11:00 AM EST
- Duration: 60 Minutes
About the Seminar
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.
About the Areas to Be Discussed
- 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- Draft guidance, issued March 5, 2013, entitled “Types of Communication During the Review of Medical Device Submissions.”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
About the Intended Attendee(s)
- Regulatory affairs in pharmaceutical and medical device industry
- Legal counsel
- Compliance officers
- Regulatory agency personnel
- Anyone interested in the subject
About the Seminar Speaker
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules, guidance, and regulatory requirements applicable to medical products. In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.
Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. 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. 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.
- Option 1: you may send your “request to purchase” by email to Global Compliance Seminar
- Option 2: you may request an invoice by email to Global Compliance Seminar
- Option 3: you may purchase online below using a credit card or PayPal.
LIVE (one attendee): $199
LIVE (≤ 4 attendees): $699
LIVE (≥ 5 attendees): $899
LIVE & Recorded: $299