Greater Houston / Galveston

The SOCRA Houston/ Galveston Chapter in conjunction with the TMC Clinical Research Institute - Presents: 

Monthly Education Training Series

November 2024 METS

Wednesday, November 6^th: Noon CST

“Medical Device IDEs, Risk Determination and FDA BIMO Inspection”

SPEAKER:    

Donna Headlee, BSN, RN, CCRP

Recently Retired Branch Chief, FDA, CDRH, OCE, DICE, PPB

OBJECTIVES:

• Define Investigational Device Exemption
• Describe the Risk Classification for medical device studies
• Discuss risk determination case study examples
• How to be ready when the FDA is at your door: Sponsor & Investigator

REGISTRATION:

https://us02web.zoom.us/meeting/register/tZEvc—srjIsGtZfNmvvqR5BgXpvB6qAs1-N 

QUESTIONS:

Please contact socrahouston@outlook.com

CE:

SOCRA continuing education unit (1) available for attendees.

 SOCRA members and non-members welcome!

December 2024 METS

Tuesday, December 3^rd: 4pm

(In-Person event followed by Happy Hour)

“The Intersection Between Clinical Research Approvals and Safety Committee Reviews and Approvals: A Primer”

SPEAKER:    

Wanda A. Quezada, BS, CIP

Director, Regulatory Oversight,

Office of Research Protection,

Houston Methodist Research Institute

Malissa Mayer-Diaz, MS, MSPH

Manager, Safety Committees

Office of Research Protections – Regulatory Oversight

Houston Methodist Research Institute

OBJECTIVES:

• Delineate the regulatory criteria that govern clinical investigations involving biologics or radioactive materials and radiation emitting devices?
• Describe the regulatory approval pathway for clinical investigations involving biologics or radioactive materials and radiation emitting devices.
• Describe how and where the safety committee and IRB reviews intersect
• Outline the regulatory reporting requirements for noncompliance with the regulations.

LOCATION:

TMC3 Collaborative Building

1885 Old Spanish Trail Houston, TX 77030

QUESTIONS:

Please contact socrahouston@outlook.com

CE:

SOCRA continuing education unit (1) available for attendees.

 SOCRA members and non-members welcome!

End of the Year Happy Hour

Tuesday, December 3^rd: 5-6pm

• Directly after our METS presentation.

REGISTRATION:

Registration is required to attend the Happy Hour event:

https://www.eventbrite.com/e/tmc-mets-networking-happy-hour-tickets-1060143500749?aff=oddtdtcreator