Marketing Authorizations-Affordable Healthcare and Fair Trade

This foundation-level module is the ideal introduction for new entrants to the field of pharmaceutical regulatory affairs and compliance. It describes the principal requirements that must be satisfied to gain and maintain approval to market medicinal products in the USA and Europe. The legal framework and the roles of major players in regulation are presented. The life-cycle of a drug is outlined. The various procedures available for assessment and approval of products are described and their requirements outlined. Obligations to be fulfilled after marketing approval are discussed. Global regulatory affairs groups in industry provide worldwide, strategic leadership in and comprehensive direction of the government regulatory requirements for product introduction and commercialization, utilizing regulatory knowledge to ensure compliance and regulatory intelligence and create opportunities in a highly-regulated environment. 

The U.S. general anaesthesia drugs market is poised to reach ~USD 2.0 Billion by 2020 from USD 1.6 Billion in 2015, at a CAGR of 3.8% from 2015 to 2020. Factors such as rapid rise in aging population, rising prevalence of cardiovascular and respiratory system-related diseases, and rising number of emergency surgeries are key factors driving the growth of the U.S. general anaesthesia drugs market. However, side effects associated with ketamine usage (such as elevation in blood pressure and heart rate, amnesia, respiratory depression, and hallucinations), regulatory issues, and lower compliance rates in comparison with other aesthetic drugs are likely to restrain the growth of this market.

The global regulatory affairs group has strategic and operational functions, requiring precision and flawless execution, as a company’s success relies on, in part, the guidance and rigorous assessment provided by the regulatory affairs team. The key product development, manufacturing and registration milestones, which are the corporate valuation and decision points, are based on critical regulatory interface goalposts and milestones. This underscores the importance of strategic regulatory contribution to the industry. In order to be valuable contributors and critical business partners, the global regulatory affairs organization must develop mechanisms and establish systems to ensure it has the right people and talent, proficient processes, prolific productivity, phenomenal performance and precision in planning.

  • Role of pharmaceutical industry in both promotion and medical education
  • Community code on medicinal products
  • FDA regulation
  • Compliance strategies
  • Pharmacoeconomics & outcomes research

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