Pharmaceutical Regulatory Affairs

Pharmaceutical Regulatory Affairs Submit Abstract Register Now

Regulatory Affairs contributes essentially to the overall success of drug development, both at early pre-marketing stages and at all times post-marketing. The pharmaceutical industry deals with an increasing number of interesting drug candidates, all of which necessitate the involvement of the Regulatory Affairs’ department. Regulatory Affairs professionals can play a key role in guiding drug development strategy in an increasingly global environment. But they also play an important operational role, for example, by considering the best processes to follow and enabling structured interaction with regulatory authorities. Regulatory Affairs is driven by good science and accordingly nothing remains static.

The overall emerging markets for therapeutic drugs totaled $131.4 billion in 2009. These regions include Latin America, China, Eastern Europe, the Middle East, South Korea, India, Russia, and South Africa. These regions are estimated at $145.8 billion in 2010 and expected to continue aggressive growth through 2015, reaching a figure of $214.2 billion, yielding a compound annual growth rate (CAGR) of 8% from 2010 to 2015.

  • Regulatory & Pharmacovigilance
  • SOPs and Policy Documents
  • Clinical Affairs & Regulatory Strategies
  • Regulatory Strategies and Developments
  • Data Integrity towards Regulatory Affairs
  • Global Regulatory Intelligence
  • Regulatory Communications and Submissions
  • Regulatory Requirements for Pharmaceuticals
  • Medical Device & Combination Products Regulations
  • Best Industry Practices
  • Marketing Authorizations
  • Regulatory Challenges for Medical Devices
  • Food, drug and cosmetic laws
  • FDA and related regulatory agencies
  • Pharmacovigilance Regulations

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