The Sucessful PMA

This eConference is the Fourth in a Four-Part Series on medical device regulations. The series consists of:

1. Part 1-Part 812 
2. Part 2-The Successful IDE 
3. Part 3-The Successful 510k
4. Part 4-The Successful PMA

This Part of the series is designed to help applicants prepare a premarket approval application (PMA) that will be complete, that FDA will find easy to review, and that will very likely lead to an approval decision within a reasonable review time. 

You will learn:
1. How PMAs differ from 510(k)s
2. How to approach FDA with preclinical and clinical testing plans  
3. The basic contents of an application
4. What to put in and how to organize each section of the application
5. Mistakes to avoid
6. Expedited review and modular PMAs 
7. How to interact with FDA during the review process
8. The criteria for approval
9. How to prepare for a panel meeting
10.Postapproval requirements
11.When PMA supplements are required

 

You will receive:
1. A foundation to build on
2. Knowledge about how to choose a predicate
3. Clarity about your options
4. Insight in dealing with problems
5. A chance to listen to other's Q&A

7. Certificate and CEUs

 

Who should attend 4:
This eConference is designed for regulatory and clinical affairs specialists who are responsible for preparing PMA applications, and for other product development people interested in understanding the PMA process.

 

Presenter:
Clinical Device Group is proud to present Mr. Gerard Prud’homme Esq. and Partner of  Hogan & Hartson, LLP. Mr. Prud’homme's practice is primarily focused on the regulation of medical devices and pharmaceuticals, where he represents both small and large manufacturers with matters before the Food and Drug Administration (FDA). He advises clients on a range of regulatory issues. In the device area, he has extensive experience in assisting companies in matters pertaining to product development and product submissions (510(k)s, IDEs, and PMAs). Gerard advises clients on both regulatory and scientific requirements, and on designing and analyzing clinical studies, in support of product submissions. He regularly counsels companies on issues relating to regulatory strategy, bioresearch monitoring, IRBs, informed consent, advertising and promotion of medical devices, regulatory due diligence reviews, as well as a variety of other FDA matters. Prior to becoming an attorney, Gerard spent more than 10 years as a biostatistician with university and nonprofit groups designing and analyzing epidemiological studies and clinical trials of medical devices and drugs. He was also a member of the faculty of the University of Maryland School of Medicine. Mr. Prud'home can be reached at GJPrudhomme@HHLAW.com .

 

The purchase is $409 for the CD. Event materials are available on the CD itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.