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

  • 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

Related Conference of Regulatory Strategies and Developments

November 09-11, 2017

4th European Biopharma Congress

Vienna, Austria
August 20-22, 2018

9th Asian Biologics and Biosimilars Congress

Tokyo, Japan

Regulatory Strategies and Developments Conference Speakers

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