WHO/GMP based pharmaceutical industries and their concepts, challenges and opportunities in regulatory strategy

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Nandita Dasgupta and Shivendu Ranjan

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

The demand for globally acceptable products heightens the imperative for harmonization of regulatory requirements to lend efficiency and cost effectiveness to the process of product development, manufacturing and expediency to global access. In addition, biopharmaceutical companies have continued to expand their frontiers to attain a global reach, with presence in many regions and countries, and therefore exposed to myriad, and sometimes diverse, regulatory requirements and operating standards. The challenges of globalization in a heterogeneous world with an evolving regulatory landscape and expectations of multiple stakeholders have increased the complexity, unpredictability and intensity of the biopharmaceutical product development and registration process. These challenges likewise reinforce the crucial role of the regulatory team and underscore the need for enhanced global regulatory function with regulatory professionals who are strong leaders, business partners and strategic contributors. Evolution in the regulatory profession has been largely driven by: Expanding scope and global reach of industry, Keen attention to global regulatory intelligence, Need for innovative and cutting edge technologies including e-submission, Complexity of disease area targets for development, Need for comprehensive and robust global regulatory strategies. The functional units of biopharmaceutical industries are: Product development HQ & regional; Chemistry, manufacturing and control (CMC), compliance, conformance; Policy and regulatory intelligence; Promotion and advertisement; Regulatory submission management; Product Labeling and its marketing.

Biography :

Nandita Dasgupta is in B.Tech Biotechnology Final year at the age of 21 years from VIT University, Vellore, Tamil Nadu. She has published 3 papers in reputed journals. She was the Student coordinator of VIT Biosummit?12, a meet between industrialists and academia. She was also student coordinator in many college tech and cultural fests. She has good subject command in depth and technical skills with excellent management skills.