Regulatory Strategies and developments

A regulatory strategy is a formal document that aligns the regulatory activities to bring a new or modified product to market with the business strategy for that product. It provides overall definition and direction to the project team for the product being developed by identifying the important regulatory elements to be addressed to market the device. Within a company, there are usually many players from a variety of departments who work on developing the regulatory strategy. Since this strategy involves all aspects of a drug, individuals with expertise in chemical synthesis, toxicology, biology, clinical and regulatory affairs, marketing, government affairs, and reimbursement should all provide input into the regulatory strategy to ensure it is as comprehensive as possible.

The regulatory strategy document has three main purposes. It needs to be:

  • A tracking tool to summarize key agreements reached with health authorities
  • A planning tool that documents timelines and lists topics to address in future meetings with health authorities
  • A risk register to record key issues that could impact timelines, costs or commercial value for the project

  • Role of QMS (Quality Management System) in Regulatory Compliance
  • Product Registration & Submission
  • Accelerating drug approval timelines
  • Improving drug and vaccine safety
  • Drug pricing mechanisms
  • Dealing with higher registration and renewal fees
  • Quality control and quality assurance
  • Current Practices in Solving Complex Regulatory matters

Related Conference of Regulatory Strategies and developments

June 06-07, 2018

International Conference & B2B on Pharma Research and Development

Philadelphia, Pennsylvania, USA
August 20-21, 2018

12th Asian Biologics and Biosimilars Congress

Tokyo, Japan
October 18-20, 2018

18th World Pharma Congress

Warsaw, Poland
November 15-16, 2018

14th International Conference on Generic Drugs and Biosimilars

Frankfurt, Germany
September 18-19, 2018

6 th European Biopharma Congress

Amsterdam, Netherlands

Regulatory Strategies and developments Conference Speakers

Recommended Sessions

Related Journals

Are you interested in