Combination Product Updates for Filing Reviews for Post Market Safety Reporting
Date : 07 January 2019
Time : 01 : 00 PM EST
Duration : 60 Minutes
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant to the life sciences industry for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex human performance problems.
This webinar is essential to understanding how your PMA is evaluated and precisely those key points that are the focus of the FDA during their review.
This webinar addresses the Final Guidance published by the FDA entitled Acceptance and Filing Reviews for Premarket Approval Applications (PMAs). The PMA regulation (21 CFR 814.42(e)) to which this guidance pertains, identifies the criteria that, if not met, may serve as a basis for the FDA’s refusal to file a PMA. This guidance document was written to help explain the preclinical and clinical issues that need to be addressed in a PMA and the key decisions that must be made during the filing process. Although created for a different internal FDA purpose, understanding the contents of this document will certainly help manufacturers to ensure that their PMA is complete and avoid a refuse to file finding. The FDA has provided a set of three checklists used by internal FDA staff to evaluate a submitted PMA. Understanding what is being evaluated can provide a significant edge and timesaving approach to the process. This webinar will review those checklists in detail.
At the completion of this webinar participants will be able to:
- Identify and state the purpose and function of this final guidance document
- Define a combination product and the new requirements for identifying combination products as specified in this document
- List and describe the combination product submissions that
- Explain the concept of “self-identify”
- Discuss the Patent and Exclusivity Provisions of the FD&C amendment to which this guidance pertains
Course Level - Beginner/intermediate
Who Should Attend
- Engineering, marketing, regulatory documentation, research & development professionals in the
- Pharma, Biologics, and Medical Devices who are involved in and responsible for a combination
- Product submissions
- Directors, managers, and associates
Why Should Attend
The primary purpose for attending this webinar is to understand what is expected from the FDA’s standpoint when submitting a PMA for your combination product. The time, effort, and corporate resources that are tied to the submittal of a PMA are too great to risk the potential for a refuse to file finding by the FDA.
- Speaker: CHARLES H. PAUL
- Webinar Code: CHAP-0009