Drug Information Association (DIA) is organising a two-day event on risk-based monitoring (RBM) on September 22 and 23, 2017 at the Courtyard by Marriott Mumbai International Airport in  Mumbai.

The reason to hold the conference is because of the entry of the latest ICHE6 R2 guidance mandating the need for 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 (Integrated Quality and Risk Management Plan) which are  pre-emptive measures that identify the latest regulations and the tools and technologies involved, said the organisers.

In addition, this conference will touch on the role of the risk based monitor and the criticality of a well outlined change management strategy, said Manoj Trivedi, Senior Manager, Business Development, DIA India.

The programme highlights the key regulations, guidance and the industry impact. This will provide the industry the knowhow  to the ideally implement an RBM model. It will delve into the risk assessment methodology and vendor choice for partnering for RBM.

The programme chair for the event is  Nimita Limaye, CEO, Nymro Clinical Consulting Services. The event organising committee has Sarvesh Singh, vice president and head of APAC -DM, ICON, Raghu Punnamaraju, sr director, software engineering, Parexel Informatics and Abhijit Parab, director - CDM and programming, Allergan.