What Firms Should Know About the FDA's Pre-Submission Process

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Wed, Nov 18, 2015
60 minutes
Product Description

Get a Better Understanding of the FDA’s Pre-Submission Program to Leverage its Benefits


Clinical trial sponsors are encouraged by the FDA to take part in the Pre-Submission (Pre-Sub) program as it allows applicants to obtain FDA feedback prior to a submission and adds transparency to the submission process. Experts also believe that an effective use of FDA’s feedback on the planned nonclinical and clinical studies can significantly help industry bring medical products on the market quicker.

This conference by expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA, is intended to discuss how to most effectively use the FDA’s pre-submission (Pre-Sub) program to seek feedback on important regulatory issues prior to submission of an IDE, PMA, HDE, 510(k), (CLIA) Waiver by Application including IND or BLA, especially for combination products.

This session will provide a great opportunity for you to get a better understanding of FDA’s pre-submission program to effectively use the program for greater benefits. You will learn what firms should know about the FDA’s pre-submission program, the FDA’s administration of pre-submission program, and best practices to effectively use the program.

Session Highlights:

  • Applicable Laws And Regulations
  • Important Definitions
  • FDA’s Current Thinking And Perspectives On the Pre-Submission Program
  • What Industry Should Know About the Pre-Submission Program?
  • When To Use The Pre-Submission Program?
  • Best Practices To Effectively Use The Pre-Submission Program: Dos And Don’ts
  • Great Examples of Effective Use of the Pre-Sub Program
  • PASS-IT Recommendations

Who Should Attend

  • Healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.
  • Compliance Officers
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • Laboratory Personnel
  • R&D Professionals
  • Consultants
  • Contractors/Subcontractors
  • Other professionals interested in this topic

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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