*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*

The session will review the current state of the art in REMS and aRMMs. It will describe how industry can respond proactively to recent convergence in guidance from FDA, EMA and CIOMS through new, more collaborative, ways of working. We will show how to build on the approaches to SBRA that were discussed in the morning session, to better align risk management objectives and the REMS lifecycle with the healthcare and real-world context to provide better support for patients and HCPs.

We will describe how effectiveness can be measured to support new expectations.

The logical approach that builds from the definition of risk management objectives through aRMM and REMS tool design to measurement of effectiveness will be highlighted through a tabletop scenario that will provide participants with hands-on experience.

Registration for Live Short Course will be accepted onsite, or until capacity has been reached. Register prior to guarantee your seat.

Receive $150 off your meeting registration by registering for both short courses plus the meeting. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.