|Tuesday, 11 December 2012|
|9:00 am||Welcome and Day 2 Overview|
|9:10 am||Regulatory Strategy Beyond Market Approval|
This session will discuss postmarket requirements that should be considered in developing a regulatory strategy. Topics may include postmarket clinical studies, postmarket reporting requirements and advertising and promotion.
|10:30 am||Biosimilars Regulatory Pathways|
This session will provide an update on regulatory pathways for biosimilars in major regulatory systems. Special attention will focus on how the development of biosimilar products will affect regulatory strategy planning for an innovator product.
|11:30 am||Case Study Analysis|
Participants will be divided into teams that will each prepare a global regulatory strategy (GRS) for the fictitious biologic product. This session will begin with an introduction of your fictional product, the Regulatory Strategy Document (RSD) template and the expectations for the template’s completion.
|1:30 pm||Group Presentations:|
In this session, the groups will present their results from the RSD with an active Q&A session.
|2:00 pm||Role of Regulatory Intelligence in Strategy Development|
This session will illustrate the role of regulatory intelligence in developing a global regulatory strategy, and the various sources of information available to stay current on the global regulatory environment.