With a view to provide better understanding of the clinical trial system of the country, Virtue Insight is organising the 5th annual clinical trials summit 2014 that will highlight as a critical guide for successfully conducting clinical trials in India on June 10 & 11 in Mumbai. The event will focus on adapting to India’s transformed regulatory landscapes to conduct clinical trials, re-thinking patient recruitment and patient experience and finding the ideal partner in outsourcing logistics operations in India etc among others.
The event plans to give an overview of Indian healthcare and clinical trial system towards 2015, analysing the recent government rules and guidelines, discovering the new trends in global clinical trials and their role in India. Another highlight will be the technologies that drive efficiencies in global clinical trials, strategies to conduct successful interventional oncology trials in India and get updates on design of clinical drug.
Special focus will also be given on understanding the expectations of regulatory authorities and what type of regulatory structure does India currently have, while deliberating on overcoming challenges faced in regulatory approval processes–obtaining drug, clinical supplies import and export licences in Asia. Experts will also conduct regulatory review at the drugs controller general of India (DCGI) and central drugs standard control organization (CDSCO): science, quality, and speed effectively incorporating GCP and GCPs – Knowing what to-do and what not to do.
Top Industry stalwarts will be coming for the event to share their expertise and knowledge on the same. Some of them are Ketan Lakdawala, vice president, professional services, Medidata (UK); Richard Young, vice president, EMEA, Medidata (UK); Arun Bhatt, president, Clininvent Research; Sofi Joseph, head–regulatory operations, Pfizer; Manish Sharma, AVP and head, medical affairs and imaging, Lambda; Retesh Kumar, associate vice president – global pharmacovigilance, Lambda; Chirag Trivedi, director & head of clinical study unit, Sanofi India; Ravisekhar Kasibhatta, vice president–clinical research, Lupin; Shabbir Rangwala, VP of clinical operations, INC; Rajesh Nachankar, senior manager clinical research, Piramal Enterprises; Bhaswat Chakraborty, senior VP and chair, research & development core committee, Cadila Pharmaceuticals etc. among others.