Concepts, challenges and opportunities in regulatory strategy of Uttar pradesh drugs and pharmaceutical company Ltd

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

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

Shivendu Ranjan and Nandita Dasgupta

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

Uttar Pradesh Drugs and Pharmaceutical Company Ltd (UPDPL), Lucknow is the only public sector drug manufacturing company of Uttar Pradesh. The plant functions at WHO/GMP guidelines. The challenging landscape is largely a result of the success of the biopharmaceutical industry in delivering medical therapies for many disease states, safety catastrophes from use of products post-approval; and product quality compliance issues. These have sharpened regulatory authorities? focus on product benefit/risk profiles and related stakeholders? views on cost effectiveness and patient access. The regulatory professional has to be equipped and poised to effectively guide the organization to success with a credible voice, informed strategic guidance and objective evaluation. The scope of the regulatory affairs group function spans the entire spectrum of product development, manufacturing, registration, post-marketing activities and lifecycle optimization. This span of involvement and responsibility is sometimes referred to as bench to bedside and beyond, from cradle to grave, from inception through lifecycle optimization, from laboratory to launch, etc. The regulatory team and professional hold a unique position of importance with impressive diversity in function and significant breadth and depth of responsibility. Key functional units are Product development, Chemistry, manufacturing and control, Policy and regulatory intelligence, Regulatory submission, Product labeling and Promotion and advertising which are having their own key roles and strategic elements of global regulatory contributions.

Biography :

Shivendu Ranjan is in B.Tech Biotechnology Final year at the age of 21 years from VIT University, Vellore, Tamil Nadu. He has published 3 papers in peer reviewed journals. He was the Student Organizer of VIT Biosummit?12, a meet between industrialists and academia. He was Manager/ Co-Organizer of graVITas?12 (College Technical Fest). He was also student coordinator in many college tech and cultural fests. He has good presentation skills with leadership and team management skills.