Transworld Institute of Professional Development and Training, established as a non-profit organisation by a group of US based pharma scientists to impart professional training, update knowledge, broaden experience in pharmaceutical related subject matters on recent developments, techniques and regulations, is planning to conduct an international workshop on Clinical Compliance in New and Generic Drug Development, at Hyderabad on July 28 and 29, 2006, B Prabha Shankar, president of Transworld informed.

The workshop to be co-organised by the Industrial Pharma Division (IPD) and AP State Branch of Indian Pharmaceutical Association, will focus on aspects such as- Indian CROs role and its regulation in generic drug development, Overview of regulations in US/EU/Japan, Protecting human subjects in clinical research-GCPs and most common failures, Clinical trials management/site-sponsor interactions, Assessment of pro-arrhythmic risk in drug development, Role of BA/ BE studies in generic drug development, Bioequivalence concept, design and analysis of bioequivalence study, and Role of biopharmaceutical classification system in generic drug development.

The key speakers include Dr Vasantha Muthuswamy, ICMR; Dr Raj Pradhan, Abbott Laboratories; Dr Charles Pierce, Pierce One and Dr Balakrishna Hosmane, Northern Illinois University.

Transworld also conducted an international workshop on Fundamentals of Clinical Trials last year at Hyderabad, which was attended by 175 professionals from across the world. Prabha Shankar said Transworld also has plans to offer online courses in clinical research and is currently in discussion with the Nizams Institute of Medical Sciences (NIMS) to develop a one year course in this field.