The sixth batch of the nine-week short-term industry oriented course run by Hitech Institute of Advanced Pharmaceutical Sciences in association with Natco Pharma will start from August 28, 2006.
The course will be followed by intensive, in depth practical training in pharma industry or approved drug testing labs with an objective of creating professional awareness among fresh pharmacy graduates.
Eminent experts from pharma industry and Drugs Control Administration will delver interactive lectures on subjects related to drugs industry and regulatory affairs.
The lectures mainly focus on topics such as US FDA regulations, international laws, DMF and ANDA submission, IPR and patents, bio-equivalence studies, pre-clinical and clinical studies, SOPs, validation and stability studies, design and layout of pharma industry and drug testing laboratory, air handling systems, schedule M, cGMP, ICH guidelines, GLPs, GCPs, and other aspects related to drug discovery and commercialization including Indian and international regulatory procedures for drug approval.
M Venkata Reddy, key coordinator and former director, AP Drug Control Administration said the course is a pioneering effort in India to organise such an elaborate an extensive industrial oriented training programme for pharmacy graduates.