In a bid to create professional awareness in the fresh graduates and postgraduates so as to bridge the gap between academic and industrial environments, Hi-Tech Institute of Advanced Pharmaceutical Sciences, a brain child of the Hyderabad-based Natco Pharma Ltd would organise a nine week short term pharma industry oriented course at Natco House, Banjara Hills, Hyderabad from May 10, 2009.
Eminent personalities from pharma industry and drugs control administration are learnt to deliver interactive lectures on subjects related to drug industry, research and development (R&D) and regulatory affairs.
"This is a pioneering effort in India to organise an elaborate and extensive industry oriented training programme for pharmacy graduates and postgraduates. Top officials from pharma industry and drugs control would cover more than 50 different pharma industry related topics at this short term course," according to sources.
Prominent personalities from the industry, including Dr M Venkateswarlu, former drugs control general of India, Dr PV Appaji, executive director of Pharmaexecil, Dr Krishna Illa, CMD of Bharat Biotech and Dr M Sivakumaran, director of Aurobindo Pharma are expected to deliver lectures and share their valuable experiences with the participants.
The lectures at this short term pharma industry oriented course are learnt to focus on US Food and Drug Administration (FDA) regulations, international laws, Drug Master File (DMF) and Abbreviated New Drug Application (ANDA) submissions, Intellectual Property Rights (IPR), patents, BA&BE studies, pre-clinical and clinical studies, SOPs, industrial safety, pollution and environmental aspects, unit operations and common reactions in active pharmaceutical ingredient (API) manufacture, validation and stability studies, particle size analysis, bulk density, impurities, design and layout of pharma industry, process chemistry of bulk drug industry, air handling and water systems, internal audits, GMP, cGMP, ICH guidelines, GLP and all matters relating to 'drug discovery to commercialisation.
Also, the course is expected to look into including Indian and international regulatory procedures for drug approvals. In addition, the course would feature 25 lectures on communication skills and 30 lectures on modern analytical techniques.