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REGULATORY AFFAIRS IN PRODUCT MANAGEMENT

REGULATORY AFFAIRS IN PRODUCT MANAGEMENT The key role of RA professional is broader than registration of products, they advise companies both strategically and technically at the highest level. Their role begins right from development of a product to making, marketing and post marketing strategies. Their advice at all stages both in terms of legal and technical requirements help companies save a lot of time and money in developing the product and marketing the same. For countries that do not have their on regulations the World Health Organization guidelines on health matters and World Trade Organization on trade regulations between nations is followed [14-16]. REGULATORY AFFAIRS IN CLINICAL TRIALS The RA professional is the primary link between the company and worldwide regulatory agencies such as US Food and Drug Administration (USFDA & Center for Devices and Radiological Health) Medicines and Healthcare Products Regulatory Agency, United Kingdom, Research Article CODEN: IJPRNK Impact Factor: 5.567 ISSN: 2277-8713 Y. Sri Harsha, IJPRBS, 2017; Volume 6(2): 170-177 IJPRBS Available Online at www.ijprbs.com 175 (UKMCA), Therapeutic Goods Administration, Australia European Medicines Agency, Organization of Economic Collaboration and Development (OECD) and Health Canada. He also communicates and interprets the seemingly endless mace of laws, regulations and guidelines to the other departments of the company. The RA personnel develops strategies to overcome delays and presents finding of clinical trials to the regulatory bodies so as to get quick clearance thus reducing the time for approval of new molecules. At its core, the RA professional facilitates the collection, analysis and communication about the risks and benefits of health products to the regulatory agencies, medical and health systems and the public. Operationally RA is responsible for assuring that government obligation, market driven demands and evolving scientific conventions are understood and addressed by various stakeholders