The three-day International Conference on 'Drug Discovery and Clinical Development in India: Opportunities and Challenges', held from Oct 16-18 at Taj Lands End Hotel in Mumbai, is aimed to spread awareness about the new environment of clinical research in India, which is all set to become a hub of clinical research.
The event is organized by the Institute of Clinical Research (India), ICRI, India's premier institution in Clinical Research studies, in association with Drug Information Association (DIA) and Biomedical Consulting International,Inc.(BCI). The event is preceded by a pre conference workshop on the 15th Oct 2006, at ICRI, Mumbai. 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; Yoshinobu Hirayama, Osaka City University, Japan; M. Venkateswarulu, Drugs Controller General Of India (DCGI); Anthony Woodman, Professor and Dean, Cranfield University, UK; Aloka Chakravarty, Center for Drug & Evaluation & Research, USA; Dr. Maharaja K. Bhan, secretary, Department Of Biotechnology (Govt. Of India). Keynote lectures, workshops, and parallel discussion and Q&A sessions will be among the highlights of the conference.
The event will be participated by professionals in the fields of academia, biostatistics, clinical research and development, clinical safety and pharmacovigilance, clinical supply operations, clinical trial and project management, contracts administration, data management, drug development and discovery, investigator site management, medical and scientific affairs, outsourcing management/ contract research organizations (CROs), pre-clinical development, post-graduate students entering pharmaceutical industry, procurement and purchasing, quality assurance, research and development, strategic sourcing/planning, regulatory affairs, government and public policy; lawmakers, senior- and executive-level decision makers for clinical trials etc.
Dr S K Gupta, Dean & 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 issues that are considered barriers to global clinical development and which have discouraged most companies from exploring India for implementing their global development plan."
The discussions would revolve around varied topics like Quality Assurance- principles and practices in clinical trials, challenges and recommendations 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 discuss on various legal issues pertaining to the conduct of clinical trials in India as well as bioethics in Clinical Research. The deliberations in the Conference are being presented by the top most authorities in the field of GCP, Pharmaco-vigilance, Bioethics and Data Management.
The objective of the pre-conference workshop is to acquaint the participants with the key application of statistical principles, develop an understanding of basic key statistical issues, which will be useful in conducting Clinical Trials and their management.