2017, September 22-23
The latest ICHE6 R2 guidance has driven even the nay-sayers to focus on developing RBM strategies. Without experience and expertise to support the same, one may actually end up adding risk to a study. The industry has an urgent need to understand the strategies involved in RBM, including the development of the IQRMP, the development of a risk scoring model, the identification of the KRIs, the SDV strategy, site-tiering strategy, the road-blocks and the pre-emptive measures, the identification of the proof points and the latest regulations and the tools and technologies involved. In addition, this conference will touch on the role of the risk based monitor and the criticality of a well outlined change management strategy.