Pharmaceutical & Health Technology

 
Duke University School of Medicine is offering a free 6-week program on Regulatory Affairs. 

April 14 to May 19.  1-hour per week via Zoom. 12 pm ET to 1 pm ET, along with independent study.  

If you have library / information center staff who need to come up to speed with this function, it will provide a great overview!

It will cover premarket regulatory work related to drugs, biologics, and medical devices, covering the following topics:

• Drug Development and FDA Meetings
• Applicability of FDA Drug Regulations to Clinical Studies
• IND Content, Format, Review and Maintenance
• Medical Device Development and FDA Meetings
• Applicability of FDA Device Regulations to Clinical Studies
• IDE Preparation, Submission, and Maintenance 
  
  Register (note that registrations will not be accepted once the course has begun):
  

  https://medschool.duke.edu/research/research-support/research-support-offices/office-regulatory-affairs-and-quality-3
  
  

  Betty Edwards | Senior Manager, Business & Scientific Literature

  Digital and Enterprise Capabilities (DEC)

  Sage Therapeutics | 215 First Street, Cambridge, MA 02142

  617-694-3369 | betty.edwards@sagerx.com | www.sagerx.com