The New Delhi based Apothecaries Foundation is conducting a two-day seminar on Good Clinical Practices for Indian healthcare professionals from November 21, 2003 at the Habitat World here. The programme, structured on ICH-GCP Guidelines, will talk about the contemporary global concepts in clinical research and is to be led by renowned GCP exponents.

The advance level course is to provide a GCP perspective and clinical quality assurance overviews to clinical research teammates. The course will provide insight for managing common site deficiencies, tips on how to detect hidden problems early and implement corrective action plans. It would also cover practical roadmap for documenting and evaluating SOPs & consent forms through interactive case studies and exercises.

The faculty includes Dr S D Seth, national professor (clinical pharmacology) at Indian Council of Medical Research, Dr Y K Gupta, Director, Indian Toxicology Research Centre, Dr Kiran Marthak, Ranbaxy Research Labs, Brijesh Regal, WHO Consultant to Drugs Controller General of India, Madhilika Kaushal, director, Drugs Development Services Apothecaries Ltd.

The course topics are the principle of ICH GCP and regulations concerning clinical trials in India, ethics committees, responsibilities of the sponsor, role of the investigator, clinical trial protocol and protocol amendments, investigator's brochure and essential documents for the conduct of a clinical trial.

The training programme is aimed at doctors, pharmacists, nurses, medical advisors, clinical research managers, senior clinical data managers and medical writers engaged in the pharmaceutical industry. This is the first of a serious of GCP training courses being planned by Apothecaries Foundation.