The Regulatory Education for Industry Annual Conference will be held May 29-30 at the Revere Hotel, 200 Stuart St., Boston.
The Center for Drug Evaluation and Research, Small Business and Industry Assistance and the Center for Devices and Radiological Health's division of industry and consumer education are sponsoring the event.
The conference will help attendees learn a foundation in the FDA’s drug and medical device regulatory requirements. There will be two tracks — drugs and devices.
The drug track will focus on New Drug Applications and Biologics License Applications. Topics for the conference include: Navigating the World of Combination Products, Regulatory Highlights for Biosimilars and Interchangeables and Building Quality Clinical Data into Premarket Approval Applications.
Those interested in NDAs and BLAs as well as newcomers, managers or directors in the drug or medical device industries are encouraged to attend. Those in regulatory affairs, research and development, quality assurance and control, and development and preparation of submissions will also find the conference beneficial.
Continuing education credits will be approved by RAPS for up to 12 credits for recertification. SQA has also pre-approved 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration. ACRP will give 1 unit for at least 45 minutes of qualified material. Participants must be in person (not online).