Returning for her third Expertbriefing, Jerri Perkins, M.D., President of Perkins & Perkins, Inc., will detail from a former FDA insider perspective how you can reduce time to market with a Pre-IND/IDE meeting.

The pre-IND/IDE meetings are critical in planning a drug or device clinical trails, This is especially true if the sponsors' questions are not fully answered by guidance's and other information provided by FDA. "Meet early and often" is FDA's suggestion for quality clinical trials. A pre-IND meeting can also provide sponsors information that will assist them in preparing to submit complete investigational new drug IND and investigational device exemption IDE applications. If you have limited experience interacting with FDA or are unfamiliar with PreIND/IDE meetings have your questions answered during this audioconference.

How to better prepare for FDA meetings. Know the importance of meeting with FDA before beginning your clinical plan. Understand when a clinical trial can begin and the minimum to get the ball rolling.

Learn how pre-IND/IDE meetings can reduce time to market by

-- Identifying and avoiding unnecessary studies
-- Gain FDA support for your proposed strategy
-- Creative exchange of ideas
-- Obtain regulatory insight
-- Minimize costs
-- Allow early interactions/negotiations with FDA

Clinical trials are costly and mistakes are more costly. Avoiding unnecessary studies can be a cost savings. There is always an interest in learning from a former FDA "insider".


Attendees will receive these free gifts:
About the Presenter

 

Jerri B. Perkins, M.D., President of Perkins & Perkins, Inc.

Dr. Perkins spent eight years at FDA as a medical officer. She was an Acting Division Director for medical devices, involved in policy decisions in the Office of the Commissioner and a Reviewing Medical Officer for drugs. She made recommendations to the FDA Commissioner on whether or not unsafe products should be recalled from the market. She also made recommendations whether or not devices and drugs were safe and effective for the US market.

In 1984, she established Perkins & Perkins, Inc, PPI, a medical and regulatory consulting firm. PPI is an independent consulting firm, assisting both pharmaceutical and medical device industries with regulatory and clinical trials quality assurance (GCP). Dr. Perkins has conducted pre-FDA audit inspections in the U.S. and Europe. Her audit reports have been used successfully to prepare sites for FDA inspections.

She has published basic research articles while at the NIH and articles regarding FDA issues. She has given numerous presentations in the USA, Europe and was an invited speaker in China.

CV and additional information including two FDA articles can be found on our web site www.xfda.net

She has published articles on HOW DOES A MEDICAL OFFICER REVIEW AN NDA SUBMISSION AND TIPS ON PMA PREPARATION/PRESENTATION.

Dr. Perkins did her post-doctoral research at the National Institutes of Health in Bethesda, MD and received her MD degree from the Medical College of Virginia.