SESSION | Strategies to Succeed During the Review Process

Wednesday, March 15 from 11:50 AM – 12:30 PM PT

  • Nada Hanafi, MSc. MPH, Sr. VP, Strategy, Regulatory, Veranex Solutions
  • Joshua Nipper, Director, Division 1, Division of Submission Support, Office of Regulatory Programs, OPEQ, CDRH, FDA

SESSION | Digital Health

Wednesday, March 15 from 2:15 – 3:00 PM PT

  • Craig Coombs, President, Coombs Medical Device Consulting
  • Zane Liu, Sr. Manager, Regulatory Affairs, Veranex Solutions
  • Brendan O’Leary, Division Director (Acting), Division of Digital Health, OPEQ, CDRH, FDA

WEBINAR | Altruism is Not Enough: The Black Community’s Participation in Clinical Research and Medical Device Product Development

Nada Hanafi, MSc. MPH, Sr. VP, Strategy, Regulatory will be moderating the panel which is presented by the MedTechColor Collaborative Community’s Product Development and Clinical Research Subcommittee. This virtual panel discussion will address the importance of participant diversity in clinical trials and medical device product development. The webinar will focus on the recruitment and retention of these diverse patient populations, the importance of diverse participation at all levels of the product development lifecycle, and will address the historical injustices in clinical research and medical device product development specific to the Black community. Our panelists will also discuss how the industry aims to address challenges to diverse participation and what solutions are needed to increase Black participation in clinical research.

The webinar takes place on Feb 27, 2023 at 2:00pm and registration is free. Access the webinar here.

View the Conference Website


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