Rajiv Gandhi Cancer Institute, Delhi is organising a one-day conference on ‘Adapting to the Current Regulatory Challenges in conduct of Clinical Research – Focus on Sites and Ethics Committees’ on November 9, 2013 at Amaltas Hall, India Habitat Centre, Delhi.

The main aim is to upgrade the knowledge of clinical research professionals on current challenges in clinical research conduct and to brainstorm and network with fellow professionals to learn from each other. The event is co-organised by Auriga Research Ltd. & SenseCR and supported by Pfizer Preferred Research Centre (PRC), RGCI.

Dr D C Doval, chief of medical oncology and director (Research) and Shilpa Garg Agrawal, founder & CEO, SenseCR will be inaugurating this event and A K Pradhan, Deputy Drug Controller India, CDSCO, will be the chief guest for the event. Pradhan will address on impact of current regulatory changes on clinical research conduct for sites.

The purpose of the workshop is to discuss the impact of current regulatory scenario on working for clinical trial sites and ethics committees; to know more about the DCGI inspection findings and learn from the same; to discuss the additional responsibilities of ethics committees in the current scenario and how can they cope with the same; to have a discussion with experts to get their views on the current burning topics like: audio – visual recording of consent process, compensation, SAE reporting, Apt selection of sites, accreditation of sites and PIs, etc.; with the current focus on compensation, there are many changes expected in the clauses of legal documents like clinical trial agreements, indemnities and insurance covers.

The workshop is a platform for the industry to get together, learn and discuss about the very recent regulatory changes – Rule 122DAB and Rule 122DD.

It is very important to upgrade their stakeholders who should attend the conference: clinicians who are involved in clinical research; clinical research coordinators; ethics committee members; other study team members involved in clinical research at sites; clinical research associates; academicians involved in clinical research training; freelancers; clinical operations managers; quality assurance managers, executives; site management organizations’ representatives; institute heads, directors, deans, etc.