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