Chiltern International is to take part in a major industry training programme in India designed to share knowledge and expertise on advanced clinical research and good clinical practice
Chiltern International will be represented at the event by the head of its new Indian office, Umakanta Sahoo, at the Bhandra Kurla commercial complex in Mumbai, 24-27 February 2005.
Dr Sahoo will address two sessions, on GCP review and monitoring and source data verification, and will cover the fundamentals of ICH-GCP and Indian GCP guidelines.
The session on monitoring and source data verification will also look at the responsibilities of monitors and review various approaches for source data verification.
The session will include group assignments and case studies.
Clinical research looks set to become one of India's fastest growing industries, according to Sahoo: "Clinical research is perceived to be a very promising and futuristic business for the Indian economy with the advantage of a huge treatment population, a well-oiled regulatory system and constantly developing infrastructure.
"To support this emerging business, there are a number of key events being organised allowing pharmaceutical companies, CROs, investigators, regulators, academic institutions and even media to come together and share knowledge and expertise." Sahoo is also to deliver a lecture at India's Academy of Clinical Excellence at the Bombay College of Pharmacy on clinical research management.
Chiltern International recently announced plans for a new office in India.
It says its expansion comes at an exciting time, with the clinical research business in India being facilitated by the positive orientation of regulators (Drugs Controller General of India) to adopt Indian GCP in line with the ICH GCP and to amend the Schedule Y of Drugs and Cosmetics Act 1940, which plans to incorporate changes that will be conductive for the conduct of clinical trials in India.
Pharmaceutical companies believe that strong intellectual property legislation is essential in order to recoup their R and D investments and so ongoing improvements in patent law will encourage them to carry out trials in India.
