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Medical Devices

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FDA Workshop: Exploration of Public Policy Development Regarding the Study and Analysis of Sex Differences in the Clinical Evaluation of Cardiovascular Medical Products, June 2, 2008

 Date, Time and Location

The meeting will be held on June 2, 2008 from 8:30 a.m. to 5 p.m. 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.

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 Agenda (preliminary)

8:30 AM Arrive at White Oak (security screening)
Registration/Continental Breakfast
9:00 AM Welcome and Introduction (Kathryn O’Callaghan, FDA Center for Devices and Radiological Health; Kathleen Uhl, FDA Office of Women’s Health)
9:15 AM

Panel 1: Sex & Gender Differences 

  • Heart Disease: Prevalence, Etiology, Presentation, Diagnosis Challenges, etc.
    Lori Mosca, Columbia University Medical Center
  • Disparities in Referral, Diagnosis, and Treatment
    Rosaly Correa-de-Araujo, Office of the Secretary/Office of Global Health Affairs; Former Director of Women’s Health & Gender-Based Research, AHRQ
  • Hospitalization and Mortality Rates
    Karen Ho, AHRQ
  • Differences in Outcomes
    Rita Redberg, UCSF School of Medicine
  • Safety or Effectiveness of Medical Products
    Dale Tavris, FDA/CDRH Office of Surveillance and Biometrics
10:30 AM Break
10:45 AM

Panel 2: Current State of Clinical Trials

  • Persistent Enrollment Disparities in CV Trials
    Patrice Desvigne-Nickens & George Sopko, NHLBI)
  • Sex-Specific Analysis and Reporting of Trial Data
    Ileana Piña, Case Western Reserve University; VA Medical Center; Medical Consultant to FDA
  • “Unknowns” Due to Lack of Research/Reporting
    Eileen Hsich, Cleveland Clinic
  • Existing Guidance & Policies: FDA & NIH
    Ameeta Parekh, FDA Office of Women’s Health
11:45 AM Assignments for Breakout Groups
12:00 PM Lunch
1:00 PM

General Breakout Discussion 

  • Group #2: Analysis, Reporting & Post-Market Considerations
    PMA/510(k)/NDA/BLA stage recommendations
2:00 PM Break
2:20 PM

Center-Specific Breakout Discussion

  • Group #1: Improving Participation (Inclusion/Enrollment)
    IDE/IND stage recommendations
  • Group #2: Analysis, Reporting & Post-Market Considerations
    PMA/510(k)/NDA/BLA stage recommendations
3:20 PM

Breakout Condensation: Cross-Center Share & Compare

  • Group #1 Improving Participation (Inclusion/Enrollment)
    IDE/IND stage recommendations
  • Group #2: Analysis, Reporting & Post-Market Considerations
    PMA/510(k)/NDA/BLA stage recommendations
4:00 PM Group #1 Presentation: Improving Participation (Inclusion/Enrollment)
Q&A
4:20 PM Group #2 Presentation: Analysis, Reporting & Post-Market Considerations
Q&A
4:40 PM Wrap Up
5:00 PM Adjourn

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 Registration

Online registrations will be taken until May 30th, 2008. A maximum of 75 registrants will be allowed.

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 Contacts

The workshop organizers may be contacted at:
Kathryn O’Callaghan
Scientific Reviewer
Division of Cardiovascular Devices
Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD 20850
Phone: (240) 276-4182
Fax: (240) 276-4166
e-mail: kathryn.ocallaghan@fda.hhs.gov

Donna R. Lochner
Deputy Director
Division of Cardiovascular Devices
Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD 20850
Phone: (240) 276-4043
Fax: (240) 276-4002
e-mail: donna.lochner@fda.hhs.gov

    
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