With an objective of creating professional awareness among the fresh graduates and postgraduates in order to bridge the gap between academy and industry, the Hyderabad-based Hitech Institute of Advanced Pharmaceutical Sciences with the help of Natco Pharma Ltd has started the 19th batch of short-term pharma industry oriented course on August 3.
According to the institute, the course will have nine-week duration followed by intensive, in depth practical training in pharma industry with an objective of creating professional awareness among the fresh graduates and post graduates so as to bridge the gap between academic and industrial environments. Eminent personalities from pharma industry and drugs control administration will deliver interactive lectures on subjects related to drug industry, R & D and regulatory affairs.
Dr Krishna Ella, CMD, Bharat Biotech, Dr M Sivakumaran, director, Aurobindo Pharma, Dr V Satyanarayana, CMD Vimta Labs and Dr M Venkateswaralu, former Drugs Control General of India (DCGI) and Dr P V Appaji, executive director, Pharmexcil will deliver lectures in the training programme.
The focus of the lectures will be mainly on the following topics: US FDA regulations, international laws, DMF and ANDA submissions, IPR, patents, bio-equivalence studies, pre-clinical and clinical studies, SOPs, industrial safety, pollution and environmental aspects, unit operations and common reactions in API manufacturing, validation and stability studies. The training programme, which would be conducted at the Natco House, will also cover GMP, cCMP, ICH Guidelines, GLP and all matters related to drug discovery.