Expanded Access to Investigational Drugs and Devices
See event flyer here
Speakers:
Robert Romanchuk
Program Agenda:
- 5:30 – 6:00pm: Registration & networking
- 6:00pm – 7:00pm: Educational presentation
- 7:00 – 7:30pm:
- Presentation by ACRP Executive Director, Jim Kremidas
- Chapter meeting
- Discussion with new Board Members
- Ratify 2017 bylaws
- Announcement of upcoming Board elections and recap of responses for call for nominations
Program Description: Join us in recounting the driving forces and events leading to Expanded Access regs, examining the regulatory structure providing expanded access to investigational drugs and devices, distinguishing the important regulatory differences between expanded access to drugs vs devices, providing an overview of the Right to Try law and compare it to Expanded Access regulations, and providing solutions to practical challenges in accessing investigational drugs and devices outside the confines of clinical research.
Upon completion of this Seminar, attendees should be able to:
- Recount the historical and ethical underpinnings of request for access to investigational products
- Describe the routes to access for investigational drugs and devices
- Describe the differences between regulations governing access to investigational devices vs drugs
- Compare the FDA mechanisms for expanded access with the Federal Regulation allowing “Right to Try”
Target Audience: All clinical research professionals
Registration Cost: FREE to all Chapter, ACRP, and non-members
Contact hours: The Association of Clinical Research Professionals (ACRP) provides 1.0 continuing education credits for the completion of this educational activity. These credits can be used to meet the certification maintenance requirement. (ACRP-2018-CPT-184)
Membership is not required for online registration of contact hours.
To receive contact hours: Register for the event, which includes a free contact hour. Sign in at the event, and attend the program.
Log on to the ACRP website then “Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Contact Hour Cost: FREE to all Chapter, ACRP, and non-members
Refund Policy: Not applicable