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Abstract

PRE-MARKETING REGULATORY DOSSIERS OF DRUG CANDIDATE THROUGH POST-MARKETING HEALTH AUTHORITIES BY REGULATORY AFFAIRS IN GLOBAL ENVIRONMENT

Kamlesh R. Prajapati and Dr. Dhrubo Jyoti Sen*

ABSTRACT

Regulatory affairs (RA) professionals play critical roles in a pharmaceutical industry because it is concern about the healthcare product lifecycle, it provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world. The role of regulatory affairs is to develop and execute a regulatory strategy to ensure that the collective efforts of the drug development team results in a product that is approvable by global regulators but is also differentiated from the competition in some way and also is to ensure that the company’s activities, from non-clinical research through to advertising and promotion, are conducted in accordance with the regulations and guidelines established by regulatory authorities. Regulatory Affairs is an attractive career choice for graduate students from a scientific background who enjoy communication and team work, are comfortable with multi-tasking and are eager to expand their knowledge in the wide realms of the Pharmaceutical world. Regulatory Affairs is a rewarding, intellectually stimulating and highly regarded profession within pharmaceutical companies. India is growing very rapidly in pharmaceutical sector; there is a need of regulatory affairs professionals to cater the current needs of industries for the global competition. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. They are required to be well versed in the laws, regulations, guidelines and guidance of the regulatory agencies. There is a growing need to incorporate the current requirements of pharmaceutical industries in the standard curriculum of pharmacy colleges to prepare the students with the latest developments to serve the industries. Many in the Regulatory Affairs Profession believe the New Approach to regulation will eventually be adopted for all healthcare products as it represents the best model for delivering new healthcare advances to market in a reasonable time with acceptable safety. Regulatory Affairs department is constantly evolving and growing and is the one which is least impacted during the Acquisition and Merger, and also during recession. Regulatory Affairs departments are growing within companies. Due to the changing resources necessary to fulfill the regulatory requirements, some companies also choose to outsource or out task regulatory affairs to external service providers. In today’s competitive environment the reduction of the time taken to reach the market is critical to a product’s and hence the company’s success. The proper conduct of its Regulatory Affairs activities is therefore of considerable economic importance for the company.

Keywords: RA, FDA, NDA, MAA, ICH, GCH, PIP, EMEA, ATMP, CMC, DIA, RAPS, TOPRA, TMF.


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