Medical Devices

FDA Workshop: Implementation of Post Approval Studies for Medical Devices, June 4-5, 2009

Date, Time and Location
Agenda
Registration
Contacts

Date, Time and Location

The meeting will be held on June 4, 2009 from 9:00 a.m. to 5 p.m. and June 5, 2009 from 9:00 a.m. to 12;00 noon at the following location:

Food and Drug Administration
Building 2, Room 2031
10903 New Hampshire Ave.
Silver Spring , MD 20993

* Please allow sufficient time for security screening.

Directions / Transportation / Parking / Hotels for the FDA White Oak Campus

Agenda

Day 1 (June 4)

8:00 am	Breakfast and Registration
9:00 am	Welcome
9:00 am	Daniel Schultz, MD, CDRH
9:05 am	Susan Gardner, PhD, CDRH
9:10 am	Donna-Bea Tilman, PhD, CDRH
Challenges in Patient Recruitment and Retention: (15 min each and one 10 min Q/A period)
9:15 am	Danica Marinac-Dabic, MD, Ph.D, CDRH, Workshop goals
9:30 am	Todd Fonseca, Medtronic, Industry perspective on patient recruitment
9:45 am	Danica Marinac-Dabic, MD, PhD, CDRH /OSB, Post-approval studies for medical devices: Challenges and opportunities
10:00 am	Christine K. Pierre, RN, RxTrials, Inc., CRO perspective on patient recruitment
10:15 am	Mark Boutin, JD, National Health Council, Patient perspective on clinical trialsparticipation
10:30 am	Q & A period
10:40 am	Coffee Break
10:55 am	David Rutledge, PharmD , Abbott Vascular, Industry perspective on patient retention
11:10 am	Mark Bray, PhD, Global Project Manager, CRO perspective on patient retention
11:25 am	CDRH/ODE, Challenges in patient recruitment and retention: Bridging the premarket and postmarket
11:40 am	Paul Gobel, Paul W. Goebel Consulting Inc, IRB considerations in implementing post-approval studies
11:55 am	Q & A period
12:05 pm	Lunch
Further Considerations in Implementing Post-Approval Studies : (15 min each and one 10 min Q/A period)
1:00 pm	Ken Getz, Center for Information & Study on Clinical Research Participation (CISCRP), Where are we now, where do we go from here?
1:15 pm	Steven Pashko, PhD, Global Late Phase Studies, Pharmacovigilance and Safety Omnicare Clinical Research, Recruitment of clinical sites for post-approval studies
1:30 pm	Gerry Prudhomme, JD, Hogan and Hartson, LLP, Legal consideration of post-approval studies
1:45 pm	Solomon Iyasu, MD, PhD, CDER/ OSE, Drugs and Devices: Common considerations in implementing post-approval studies
2:00 pm	Q & A period
2:10 pm	Break
2:20 pm	Break-out-Sessions: Recruitment and Retention of Participants (Attendees will be broken into two groups) Session I Leaders: Ellen Pinnow, MS, CDRH/OSB and Stan Harris, Wright Medical Technology Session II Leaders: Daniel Canos MPH, CDRH/OSB and Heidi Hinrichs, St. Jude Medical
4:45 pm	Summary of Day 1, Danica Marinac-Dabic, MD, Ph.D, CDRH/OSB

Day 2 (June 5)

8:00 am	Breakfast/Discussions
9:00 am	Summary of Break-out Session and Discussions: What have we learned: Identifying the critical issues Session I Leaders: Ellen Pinnow, MS, CDRH/OSB and Stan Harris, Wright Medical Technology Session II Leaders: Daniel Canos MPH, CDRH/OSB and Heidi Hinrichs, St. Jude Medical
10:15 am	Break
10:30 am	Panel Discussion: Where do we go from here: Identifying priorities and next steps Panelists include: Joel Batts, Wright Medical Technology Jodi Akin, MSN, Edwards Lifesciences Thomas Gross, MD, MPH, CDRH/OSB Malvina Eydelman, MD, CDRH/ODE Michael Domanski, MD, NIH/NHLBI CDRH/ODE Representative
11:50 am	Summary Wrap-up, Danica Marinac-Dabic, MD, Ph.D, CDRH/OSB
12:00 noon	End of Workshop

Registration

Registration will be handled by Social and Scientific Systems. To register please email your name, title, organization affiliation, address, and email contact information to SZafonte@s-3.com.

Registration will be on a first-come, first served basis. Non-US citizens are subject to additional security screening, and should register as early as possible.

Contacts

The workshop organizer may be contacted at:

Ellen Pinnow
Epidemiologist
Division of Epidemiology
Office of Surveillance and Biometrics
Center for Devices and Radiological Health,
Food and Drug Administration
1350 Piccard Drive
Rockville, MD 20850
Phone: (240) 276-2373
e-mail: ellen.pinnow@fda.hhs.gov