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

July 03-05, 2017

4th Annual Congress on Drug Discovery & Designing

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8th Asian Biologics and Biosimilars Congress

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10th Pharmacovigilance Congress

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7th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR

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6th International Summit on GMP, GCP & Quality Control

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World Congress on Antibiotics: R&D, Market

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12th World Pharma Congress

Budapest, Hungary
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11th World Drug Delivery Summit

(10 Plenary Forums - 1Event)
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10th International Conference and Exhibition on Biologics and Biosimilars

San Francisco, California, USA
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4th European Biopharma Congress

Vienna, Austria
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7th Global Mass Spectrometry Congress

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