Pharmaceutical Regulatory Affairs and IPR

Regulatory Cooperation and Reliance

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For a trade whose business has sustained decades of respectable growth and margins. The novel Regulatory aspects include Novel Drug Delivery Systems, Medical Affairs, Active Pharmaceutical Ingredients, and Licensing in pharmaceutical production, packaging materials and pharmaceutical excipients. The new setting is testing the resilience and ingenuity of company corporations across the world. Some business models lack the ability to survive the approaching finish of the “blockbuster drug” era, even whereas resource constraints and sluggish innovation hinder the event of recent capabilities required to thrive in a very apace evolving market. These square measure so tumultuous times for the U.S. company trade. Succeeding in a very shifting world market and evolving tending landscape would require pharmaceutical corporations to adopt innovative business models targeted on novel ways, including: stress on “economic” outcomes: additional attention to the “economic value” of a medical care as a determinant for analysis funding and development. Personalised medicine: Shifting from “blockbuster drugs” to “personalized health and wellbeing.” Externalization and collaboration: additional reliance on external partners, academia, trade consortia and entrepreneurs for innovation, productivity and world growth. Globalization: fast growth to for countries for scientific talent and new markets. Health IT adoption: finance in new technologies to modify innovation and drive efficiencies. Novel Regulatory strategies include both Nano therapeutics and biotech therapeutics.

Pharmaceutical and drug registration is also becoming more regulated throughout Asia. Indeed, the requirements for local drug clinical trials are becoming more prevalent in some countries like Korea and Taiwan. With innovation key to growth in emerging markets, regulatory policies are becoming more open and supportive of innovative drugs. There are several challenges around pharmacovigilance in Asia. India plans to begin interacting with international pharmacovigilance bodies in 2013/14  by which time it will be among the biggest pharmaceutical markets in the world before creating an Asia-Pacific centre of excellence for pharmacovigilance in 2014/15.The complicated regulatory landscape in Asia can be a barrier to success for foreign companies that do not have the experience or resources that are essential to overcome the obstacles in countries such as China, India, Japan, Korea and Taiwan