02 Dec BBA Regulatory Experts to Kick Off MassMEDIC Meeting with Presentation on FDA EFS-IDE Program
Marlborough, MA – Mack Rubley, Vice President of Consulting Services and Marybeth Gamber, Senior Regulatory Affairs Principal in Consulting Services at BBA, will present a one-hour program entitled “FDA EFS-IDE Program: Experiences and Lessons Learned” at a MassMEDIC program on Thursday, December 8, 2016 at the Massachusetts Medical Society in Waltham, MA. Their presentation will focus on the FDA EFS-IDE program creation, process stakeholder impact, differences from the traditional IDE program and the lessons learned from recent experiences in navigating this novel IDE program . The MassMEDIC daylong program is designed to give RA, QA and C-level executives a one-day crash course on the pending regulatory issues facing the industry.
To view the slides from this presentation, download the PDF.
For more on this program, please visit https://www.massmedic.com/events/fda-update-2016/