Pathways to faster medicine approval

Get an overview of established and new pathways in the EU, UK and US
No available dates

On location

English

5,800 DKK ex VAT
(app. 780 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

The demand for shorter regulatory review timelines during COVID-19 has proven that it is crucial for the life science industry to look into alternative regulatory pathways.

Get an overview of the EU, UK and US approach at this course where experts from authorities and the industry share their experiences and perspectives. Also, we will discuss the criteria that apply including what kind of medical need would justify the different options.
 

Key words

  • Alternative regulatory approvals
  • Approval timelines
  • Rolling review
  • Medical need
  • Shorter review timelines
  • Emergency use
  • Accelerated review

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IS THIS COURSE FOR YOU?

This course is for project and regulatory leaders as well as pharmaceutical specialists with an advanced level of regulatory experience (minimum 2 years).

What you will learn

  1. Knowledge of alternative regulatory pathways in the EU, UK and US
  2. Dynamics of development of medicines with shortened review times
  3. Preconditions for approval of medicines based on less clinical data than normally required
  4. Appliance of emergency use authorisations
  5. Use of temporary regulatory approvals

What your company will get

  1. An employee who understands the situations that qualify for abbreviated and special pathways in the EU, UK and US jurisdictions.
  2. An employee who knows the principles of development of medicines with shortened review times.
  3. An employee who is familiar with alternative approval pathways, emergency use authorisations and temporary approvals.

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Want to know more, or need help?

Contact Client Manager Mette Ribergaard Rasmussen at +45 39 15 09 30

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