Pharmaceutical Regulatory Affairs and IPR

Regulation and Global Regulatory Affairs

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The regulatory landscape has continued to evolve in response to product safety, regulatory compliance, new technologies, improved understanding of disease states, stakeholder and customer needs and global imperatives, with new and increasing regulations, regulatory guidance and oversight. The Global regulatory affairs group and the regulatory professionals in the biopharmaceutical industry occupy a central and pivotal role to all the functional groups. The regulatory team is charged with a strong leadership role that ensures compliance with regulations and enables understanding and interpretation of the dynamic regulatory landscape, while creating opportunities in the highly-regulated and complex environment. 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 global Active Pharmaceutical Ingredients Market is expected to reach USD 205.51 billion by 2020 from USD 150 billion in 2015, at a CAGR of 6.5% during the forecast period. Factors such as the increasing incidence of life style and age related diseases, Increasing prevalence of cancer across the world, Technological advancements in the APIs Manufacturing, Emerging markets for biosimilar and increasing scope for Highly potent active ingredients are driving market growth. On the other hand, stringent regulatory requirements and global economic recession may restrict market growth.October 2015   $ 4650 selected