Virtue Insight, Tamil Nadu will organise the 3rd Annual Clinical Trials Asia Summit 2012 - “A critical guide for successfully conducting clinical trials” on February 9 in Mumbai.

The summit aims to provide a detailed analysis of what it takes to conduct clinical trials from a biopharmaceuticals and vaccines perspective in India and China and also addressing risk/benefit balance, anecdotal experiences of the MNCs in India and China, selection and role of CROs, logistics of operations, clinical trials management, government policies and pharmacovigilance.

This summit will target IPOs, generic pharmaceutical companies, CROs, patient recruitment companies, Government- Department of Health, non-profit organisations/ association, academics and consultants.

The key speakers present at the event includes: Arun Bhatt, president, Clininvent Research; Deven Parmar, vice president - Global Clinical Research; Arani Chatterjee, senior vice president, Clinical Research, Panacea Biotec; D Roy, deputy drugs controller (India), CDSCO – North Zone; R H Jani, senior Senior Vice President, Clinical R&D, Cadila Healthcare; etc.

The summit will examine the current issues faced in clinical trials operations, addressing the risks, timeline and budget stipulations, while effectively tackling key challenges in overcoming trials agreement and site contract arbitration problems. It will also discuss the operational element of trial site management, strategic partnership with CROs and SMOs, patient, talent and investigators management in order to improve and optimise the overall drug development effectiveness and ROI.  The summit will help to discover on how to implement and benefit from electronic data management & monitoring cost effectively.

Some of the key themes to be discussed at the summit include: overview of Indian healthcare and clinical trial system towards 2013, discovering the new trends in global clinical trials and their role in India, strategies to conduct successful interventional oncology trials in India, future expectations of regulatory authorities and the type of regulatory structure present in India, challenges faced in regulatory approval processes, regulatory review at the DCGI and CDSCO, etc.