Module 1 2021

28-6-2021

In This presentation we covered

 Why and when is a regulatory strategy needed?  The aspects of a regulatory strategy  What are the current trends in pharmaceutical industry?  How will these trends in pharmaceutical industry affect the regulatory strategy?

The Organisation for Professionals in Regulatory Affairs

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Recommended references

 TOPRA Regulatory Rapporteur February 2014  The use of EPARs in regulatory strategy for biologics and advanced therapies; TOPRA Regulatory Rapporteur Vol 17 No 6 June 2020  Regulatory affairs strategic planning: how to do it well; TOPRA Regulatory Rapporteur Vol 17 No 10 Oct 2020  Worldwide Update, FDA and NIH heads outline plan for personalised medicine; RAJ Vol 21 No 8 August 2010, page 520  Porter M.E. (1980) Competitive Strategy; Techniques for Analyzing Industries and Competitors. London, Free Press

The Organisation for Professionals in Regulatory Affairs

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