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April Training Workshop: Making sense of FDA Land in Submissions (510(k)s, De Novos and PMAs)

March 10, 2019

 

 

REGISTER HERE

 

 

Making sense of FDA Land in Submissions (510(k)s, De Novos and PMAs)

Training Workshop

 

Saturday, April 06, 2019  

 

 

FLYER

 

 

Event Agenda:

 

Date: Saturday, 06 April 2019


Time*:

8:30 - 9:00 AM       Registration

9:00 - 9:10 AM       Welcome and Introduction

9:10 - 12:00 PM      Training Session

12:00 - 12:45 PM    Lunch

12:45 - 2:15 PM       Training Session

2:15 - 3:45 PM         Q&A

*Times are approximate.

 

Speaker:

Tom Hughes,
Senior Principal Advisor,
RCRI Inc.

 

 

Program Topic:

This workshop will take the beginning regulatory affairs professional and the veteran through the basics of medical device submissions to FDA. The speakers Mark Duval and Lisa Pritchard will share with the audience insights as to how their firm DuVal & Associates makes submissions that are designed to succeed and avoid wasting time and making common mistakes. The speakers have hundreds of submissions under their belt and are at the FDA physically about three times per month representing clients in pre-sub, 510(k), de novo and PMA negotiations. Their relationships with FDA and the knack for persuading FDA to their clients’ position are their stocks-in-trade.

 

Speaker Biography:

 

Mark DuVal, J.D., is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries.

 

His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc.

 

Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally.

 

Mark earned his Juris Doctor from the William Mitchell College of Law where he served as executive editor on the law review, and his Bachelor of Arts in Public Administration from St. Cloud State University.

 

Mark is a frequent national speaker and writer on issues relating to product approvals/clearances; combination products, product advertising and promotion, Anti-kickback and False Claims Act (reimbursement) matters.

 

Lisa Pritchard, BSEEE, is a Regulatory, Quality & Compliance Consultant at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. She focuses on advising clients on Regulatory, Quality and Compliance topics.

 

Lisa works extensively with assisting clients with worldwide regulatory strategies, marketing submissions and applications (FDA submissions including pre-submissions, 510(k)s, de novos, PMAs, advisory panel meeting preparation, etc.; European Design Dossiers and Technical Files, Canadian license applications, Australian listing applications, etc.); quality system strategies and compliance topics. Lisa brings over 25 years of experience in working with industry.

 

Prior to joining DuVal & Associates, she executed successful Regulatory, Quality and Compliance strategies at a variety of device companies including American Medical Systems, Medtronic, UroMedica, and EnteroMedics. Lisa earned her Bachelor of Science, Electrical and Electronics Engineering, from North Dakota State University.

 

LOCATION:

Pfizer Inc.

10770 Science Center Drive (visitors center)

Conference Room #1110

San Diego, CA 92121

 

 

* Please make your reservation early. The pre-registration due date is Wednesday, 03 April 2019. Advanced registration is appreciated to assist in event planning.

 

** Registration is capped at 85 participants. Register today to ensure your seat. Once our limit is reached, registration will close. There will be no onsite registration for this event.

 


Online registration (through Wednesday, April 03, 2019):
$30 SDRAN Member

$50 Non-Member

 


Onsite Registration:

No Onsite Registration

 

 

For Questions Email: programs@sdran.org

 

 

DIRECTIONS

 

From the North:

I-5 South toward San Diego

Take Exit 29, turn left into Genesee Ave

Turn right onto Science Center Dr

CB2 Visitors Center is located at the end of the cul-de-sac

 

 

From the South:

I-5 North toward Downtown

Take Exit 29, turn right into Genesee Ave

Turn right onto Science Center Dr

CB2 Visitors Center is located at the end of the cul-de-sac

 

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