ACDM Hot Topic Discussion - RBM are we there yet - 6th July



29-Jun-16

Introduction

In order to satisfy the regulatory requirements (ICH Q9), companies are required to utilise a risk based approach. In order to implement a RBM system a number of challenges have to be addressed. In addition there has been speculation as to what is, and what is not, acceptable to the regulators.  This discussion will give an opportunity to explore some of the basic challenges and offer possible solutions, or at least reach a consensus as to what is acceptable.

Why Attend?

This hot topic discussion will discuss four basic challenges to adopting a RBM approach

- Looking at some of the issues, challenges and misconceptions

  • Which risk management methods and tools should we use?
  • What are the IT challenges to adopting a RBM approach?
  • Is RBM a cost saving exercise that allows shortcuts to be taken?
  • Is there a set of generic KRIs that apply to all studies?

Who should attend?

Any clinical research professional embarking on a risk-based approach would benefit from attending this discussion. Hopefully the discussion should allow participants to appraise their current methodologies and practices to identify possible improvements to ensure patient safety and data quality.

Why not join us to discuss this intertesting topic and give us your perspective and share your experiences with others across the industry on Wednesday 6th July @ 12pm GMT

These interactive session will be totally FREE of charge to ACDM members and will be around an hour long.

To take part in the teleconference discussion, please email hottopics@acdm.org.uk to confirm your attendance to the host, Sue Fitzpatrick who will provide you with dial in details



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