Institute of Intellectual Property Studies (IIPS), Mumbai will start the six month diploma course in drug regulatory and intellectual property (DRIP) from November 5, 2011 for pharma, biotechnology and professionals from the industry.
The course includes the subjects relating to the intellectual property rights and dealings with drug regulatory, introduction to intellectual property, its development, free trade and competition, Indian Patent Act's concepts, prosecution and infringement, information about the drug regulatory bodies worldwide, common technical documents for formulation and API, different types of drug master files, GMP and GLP.
The course is intended for the pharma /biotechnology / biochem / microbiology, chemical engineering graduates and others interested in or working under the broad canopy of pharma regulatory affairs, e.g. employees in QA/QC, CMC, analytical development and pharmaceutical development.
Anuradha Maheshwari, director, IIPS said, “The pharma industry focusses much more on human healthcare development and treatment which deals directly to the public interest and welfare with crucial bearings on drug efficacy, quality, safety, not to mention the environmental, ethical and moral implications. Therefore it becomes imperative for the drug industry to comply with the closely monitored regulatory system surrounding it through domestic and international laws and policies.”
DRIP aims to equip the pharma professionals with working knowledge of the discipline of Intellectual Property Rights (IPRs.and regulatory affairs which helps in the growth and survival of the employer's pharma company.
She added that the complex issues related to research, development and determined market products which needs the expert management and protection in respect of its intangible assets and intellectual properties as well as with the regulatory authorities and constant compliance oversight.
She informed that IIPS will commence this course on Saturdays and Sundays and the estimated cost will be Rs.50,000. Expert professionals with a fair understanding of the processes, laws and agencies are greatly in demand and are required to deal with the aspects of drug regulation by having a great bearing and influence on the drug development process and the success of it.
Source:Pharmabiz
No comments:
Post a Comment