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8:30 a.m. – 8:45 a.m.

Welcoming Remarks

Kristin Davenport, Of Counsel, Covington & Burling

 

8:45 a.m. – 10:00 a.m.

Drug Pharmacovigilance Under CDER

Moderator: Paula Katz, Special Counsel, Covington & Burling

Panelist: Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health

Panelist: Brian Malkin, Of Counsel, Arent Fox

 

10:15 a.m. – 12:00 p.m.

Device Post-Market Surveillance Under CDRH & §522

Moderator: Christina Kuhn, Associate, Covington & Burling

Panelist: Kim Graul, Director, Post-Market Safety, Stryker

Panelist: Dr. Susan Alpert, Principal, SFA Regulatory, LLC

 

1:00 p.m. – 1:45 p.m.

Surveillance Using Sentinel and iMEDS Program

Moderator: Julia Post, Associate, Covington & Burling

Speaker: Karen C. Corallo, Of Counsel, Health Care and Life Sciences, Skadden, Arps, Slate, Meagher & Flom LLP and Affiliates

 

1:45 p.m. – 2:30 p.m.

Current FDA Initiatives and Opportunities Under 21st Century Cures & PDUFA VI (No slides for this session)

Moderator: Gary Heimberg, Of Counsel, Covington & Burling

Panelist: Krista Carver, Partner, Covington & Burling

Panelist: Remy Brim, Vice President Regulatory Policy and Strategy, BGR Group

 

2:45 p.m. – 3:30 p.m.

How Real World Evidence is Really Being Used in the Real World

Moderator: Matthew Hegreness, Associate, Covington & Burling

Panelist: Michael S. Labson, Partner, Covington & Burling

Panelist: Megan O’Boyle, Principal Investigator for PCORnet’s Phelan-McDermid Syndrome Data Network (PMS_DN) and the Phelan-McDermid Syndrome International Registry

 

3:30 p.m. – 4:00 p.m.

Drug and Device Post-Market Surveillance Horror Stories, and Hypotheticals & Q&A with Audience (No slides for this session)

Moderator: Kristin Davenport, Of Counsel, Covington & Burling

Panelist: Kim Graul, Director, Post-Market Safety, Stryker

Panelist: Dr. Susan Alpert, Principal, SFA Regulatory, LLC

Panelist: Remy Brim, Vice President Regulatory Policy and Strategy, BGR Group