Institute of Clinical Research (India), ICRI, a non profit organisation and India's premier institution in clinical research studies, in association with Drug Information Association (DIA) and Biomedical Consulting International, Inc. (BCI) is holding a three day international conference on "Drug Discovery and Clinical Development in India" Opportunities and Challenges from Oct 16- 18 at Taj Lands Hotel in Mumbai. This annual conference is being held for the first time in India and will be preceded by a pre- conference workshops on the 15th Oct 2006, at ICRI, Mumbai.

The objective of the conference is to gain expert perspectives from international regulatory, industry and academia professionals and to spread awareness about the new environment of clinical research in India.

The three day conference will witness participation of experts from Indian and International regulatory, industry and academia such as Satish C Tripathi, director, Worldwide Regulatory Strategy, Pfizer, Inc., USA; Hannah E. Kettler, Bill and Melinda Gates Foundation, USA; Dr Maharaja K. Bhan, Secretary, Department of biotechnology (Govt of India ), M, Venkateswarulu, Drugs Controller General of india (DCGI): Anthony Woodman, Professor and Dean, Cranfield University, UK; Some of the key industry participants include Dr Swati Piramal of Nicholas Piramal India etc. the international regulatory bodies are represented by senior officials from the Center for Drug and Evaluation and Research, USA including Aloka Chakravarty, director, Division of Biometrics.

Keynote lectures, workshops, and parallel discussion and Q&A session will be highlight of the conference.

Dr S K Gupta, dean and director general, ICRI, says, " besides discussing the regulatory principles and procedures in clinical research, this conference aims at providing a platform for an interaction amongst the stakeholders from the field of clinical research across the world, review and evaluation of clinical research environment in India. It is extremely important to address all India specific issue that are considered barriers to global clinical development and which have discouraged most companies from exploring India for implementing their global development plan."

Marlynn Orlando, assistant executive director, Drug Information Association said, " with India holding a strong position as a center for excellence for clinical research, it is estimated that India will account for 22 per cent of research and development. Clinical research Outsourcing is a young industry worth USD 380 million a year in India and it is growing at a phenomenal rate. Hence India is poised to become the clinical research off shoring hub for the world's leading pharmaceutical companies. Conducting clinical trials in India is a win situation for all."

The discussions would revolve around varied topics like QA- principles and practices in clinical trials, challenges and recommendation related to improving quality in the clinical trial environment; clinical trials in India II- India's potential of clinical trial over next 4-5 years and the challenge of expanding investigator database with a focus on potential strategies to achieve the expected growth in clinical research, the panel of speakers will also put forward their thoughts on various legal issues pertaining to the conduct of clinical trials in India as well as bioethics in clinical research.

The top most authorities in the field of GCP, Pharmacovigilance, bioethics and Data management are presenting the papers deliberations in the conference.

The pre conference workshops is to acquaint the participants with key application of statistical principles, develop an understandings of basic key statistical issues which will be useful in conducting clinical trials and its management.