Programs & Events

FDA's Guidance: New Medical Device Premarket Processes

A LifeScience Alley Featured Program

3/29/2012

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Time

Registration: 8:00 am - 8:30 am
Program: 8:30 am - 4:30 pm

Event Description

In the past several months, CDRH has issued more new guidances and SOPs than at any time in modern memory. These guidances address issues of critical importance to the device industry and cut across all product types. Experienced regulatory professionals are scrambling to keep abreast of these new requirements and are struggling to understand the details and implications of them all.

Topics include
• New clinical trial guidances
• Access to experts and CSC
• New 510(k) paradigm
• Washington Update Modifications
• Risk Benefit
• De novo and HDE
• Special products and situations - Mobile medical Apps, MDDS, etc
• 522 orders and post market
• Appeals

LifeScience Alley is proud to co-host this meeting with the Minnesota State Bar Association's Food & Drug Law Section. 5 hours of Standard CLE credits have been applied for. The event code is 165607.

Speakers

Ralph F. Hall, JD, Professor, University of Minnesota - Law School; Mark DuVal, J.D., President, DuVal & Associates, P.A.; Mark Gardner, MBA, JD, Attorney, DuVal & Associates, P.A.; Vincent J. Ventimiglia, Jr., JD, Sr. Vice President, Faegre Baker Daniels LLP; Robert Klepinski, Officer, Fredrikson & Byron, P.A.; Christopher Pulling, MS, Partner, The Integra Group; Dianna L. Johannson, Sr. Pr. Regulatory Affairs Specialist, Medtronic, Inc.; Andy Anderson, PhD, Senior Principal Advisor, Regulatory & Clinical Research Institute, Inc. (RCRI)

Ralph F. Hall, JD has extensive experience in the areas of FDA, health care law and corporate compliance, including the application of those regulatory (more)

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. (more)

Mark Gardner, MBA, JD is an Associate Attorney at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. (more)

Vincent J. Ventimiglia, Jr., JD serves as counsel with Baker & Daniels' health and life sciences practice. He recently left the U.S. Department of Health and Human Services (HHS), where he was (more)

Robert Klepinski is an Officer with Fredrikson & Byron and practices in the Food, Drug & Medical Device, Health Care Fraud & Compliance and Intellectual (more)

Christopher Pulling, MS is a Principal Statistical Consultant and CEO of The Integra Group. Chris holds a BA in mathematics from Hamline University and an MS in biostatistics (more)

Dianna L. Johannson is a Senior Principal Regulatory Affairs Specialist at Medtronic, Inc. She brings over 14 years of regulatory experience (more)

Andy Anderson, PhD is a Principal Advisor at RCRI, Inc. He brings over 25 years of strategic regulatory, clinical, and research and development experience to RCRI.(more)

Topics

The following topics will be addressed:

  • Regulatory Affairs

Location

Crowne Plaza Minneapolis North
2200 Freeway Blvd.
Minneapolis, MN 55430
Directions

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