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

In this short course, we aim to introduce the basic concepts of comparative BR management based on industry’s best practices and the CIOMS XII guidance document. BR assessment has become an integrated part of any regulatory decision making for the marketing approval of medicinal products, as no product can be approved nor maintained if the BR profile is unfavorable. Most thinking about BR assessments used to focus on post-approval activities, but over the last years the emphasis has been extending to the pre-approval phase. BR assessments should be performed in a transparent way, based on scientifically sound and robust evidence, as well as subjective value judgements.

We will show the necessary steps in establishing and maintaining BR profiles for new and established therapeutic products.

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