New Delhi, January 27: Department of Biotechnology’s Biotechnology Industry Research Assistance Council is providing support to two training programmes, one on good clinical practice (GCP) and another on good clinical laboratory practice (GCLP) under the aegis of National Biopharma Mission.
Clinical Development Services Agency, an extra-mural unit of Department of Biotechnology’s Faridabad-based Transitional Health Science and Technology Institute is organizing the programmes.
The first one on good clinical practice would be held from January 28 to29 and the second one on good clinical laboratory practice from January 30 to31.
Objective of National Biopharma Mission
The objective of National Biopharma Mission is to develop India’s technological and product development capabilities in biopharmaceuticals to a globally competitive level over the next decade. Biotech Consortium India Limited is the Management Agency for organizing skill development programmes across the country. CDSA, which is organizing the programme, is a pioneer in building capacity and capability in the area of clinical development and translational research in India.
The two-day programme on good clinical practice (GCP) shall create awareness and understanding of various guidelines and regulatory requirements in clinical practice.
The recent launch of the New Drugs and Clinical Trials Rules, 2019 (NDCT) on March 19, 2019 opens up a new set of excellent opportunities to accelerate innovations in India. In-depth understanding of the current regulatory procedures with knowledge of best global practices shall lead to successful implementation of projects.
The training programme on good clinical laboratory practice (GCLP), in turn, assumes importance as it is a set of standards that provide guidance on implementing good laboratory practice and good clinical practice principles to the analysis of samples from a clinical trial.
By combining the GLP and GCP sets of guidelines, GCLP ensures the reliability, quality, consistency, and integrity of the clinical trial data generated by laboratories. Compliance with this standard provides assurance that the data and reported results are credible and accurate and that the rights, safety, and confidentiality of trial subjects are protected.