Clinical investigations of combined use product scenarios, such as cross labeled or co-packaged medicine delivery systems or medical devices used for data collection in medicine studies, are associated with complex investigational approval pathways in some global regions. Following a brief overview of European requirements for combined use studies, the session will feature on-body injector case studies, highlighting challenges and lessons learned, including experience from the EU Pilot program (a precursor to the European Commission’s COMBINE project, which is intended to simplify clinical investigations including medicinal products, medical devices, and in-vitro diagnostics).
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected]
Speaker
