The Hitech Institute of Advanced Pharmaceutical Sciences in association with Natco Pharma is starting its seventh batch of nine-week industry-oriented course for pharmacy graduates from October 27 at Natco's premises, Hyderabad.
The course will be followed by intensive practical training in pharma industry or approved drug testing laboratories. Eminent experts from the industry, regulatory and research fields will deliver lectures on relevant subjects. Experts such as Dr M Venkateswarlu, DCG(I) will also share their experiences and observations on various facets of the industry.
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.
Other aspects related to drug discovery and commercialization including Indian and international regulatory procedures for drug approval would also be covered, according to M Venkata Reddy, Course- director.