Conducting clinical trials in India – Is it the right time?
Sponsored by: Syngene International Limited
- Clinical Trial
Date: 13 November
Time: 3PM London/10AM New York
Focus on Oncology clinical trials
India has been part of global clinical trial scene for the past two decades. Clinical trials were streamlined with the publication of Indian GCP and the modification of regulations governing drug development around 2005 – 6. These developments encouraged India’s participation in many global clinical trials in the intervening years. Judicial intervention in the year 2012 regarding certain clinical trial conduct lapses at few hospitals meant changes to regulatory review process, rules regarding registration and governance of institution ethics committees, site capabilities and investigator qualifications, consenting process and documentation, compensation towards clinical trial related injury etc. There were subsequent modifications to many of these rules in the coming years. Opaque and unpredictable regulatory review process, frequent policy changes proved very disruptive and virtually stopped many from considering India for their clinical trial programs.
In the last two years the regulations governing clinical trials have been streamlined:
• Review process has become lot more transparent and predictable
• Apprehensions regarding certain site and investigator requirements, consent process, compensation for trial related injury etc have been put to rest.
• Focus of various stakeholders is now rightly shifted towards conducting clinical research based on science, ethics and regulatory compliance.
Globally, the largest number of clinical trials are being conducted in Oncology indications. The International Agency for Research on Cancer GLOBOCAN project estimates that the burden of cancer in India is likely to almost double with an estimated incidence of 1 million cases in 2012 to about 1.7 million in 2035
• India has one of the highest incidence rate of head and neck, cervical and ovarian cancers.
• The incidence rate of these cancers which are relatively low in developed countries and equally high incidence rate of other indications like colorectal, lung and breast cancers provides an unique opportunity for considering India as site for conducting clinical trials in these indications
The webinar will help us to understand the current regulatory landscape for conducting clinical trials and why we should consider India as destination for conducting Oncology clinical trials.
Dr Anand Eswaraiah, MD,
Head, Medical and Regulatory Affairs, Syngene International Limited
He is a Physician and done his MD from AIIMS, New Delhi. He brings with him over 18 years of academic and biopharma industry insight and experience. Has worked on all the phases of biopharmaceutical clinical development in various therapeutic areas with rich experience in Oncology indication. He and his team work with the Biopharma companies on study conceptualization, execution and regulatory strategy. His continuous interaction with both the regulatory agencies and the clinicians provides the rare blend of scientific temper and strategic insight needed by the biopharma executives in making important decisions related to clinical development.
Key Learning Objectives
- What are the positive changes in the regulations governing clinical trials
- Oncology indications â€“ facts about India
- Why we should consider India for conducting Oncology clinical trials
- Why we should consider Syngene as partner of choice for running clinical trials in India
- Chief Scientific Officer
- Head - Clinical Development
- Head â€“ R&D
- Chief Medical Officer
- Head â€“ Global Clinical Trials
- Head- Regulatory Affairs
- Medical Director
- Clinical Trial Manager
- Manager-Medical Affairs
- Regulatory Affairs Manager
- Clinical Operation Manager