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Introductory Course into EU Regulatory Affairs (Modules 1+2)

Introductory Course
Introductory Course
Course Nr. 001

What You Will Learn In This Course

Module 1

  • Why regulation? Why is it important?
  • What do regulatory professionals do?
  • How are chemical or pharmaceutical products developed?
  • Key activities of the RA function
  • Short overview of some regulatory agencies in Europe
  • "Homework" that helps you to get to know some laws, authorities and their area of responsibilities
  • Solutions so you can check your homework

Module 2

  • Dossiers, their format and structure using the example of a pharmaceutical product for human use and a plant protection product
  • Good Regulatory Practice – Guidance on how a regulatory framework should look like
  • The EU Regulatory Framework
  • How to find laws and guidelines on the internet and how to read legal texts fast
  • Short profiles of regulations: human and veterinary pharmaceuticals, biocides, chemicals and plant protection products
  • Some “homework” to deepen your understanding and apply search strategies
  • Solutions so you can check your homework


  • You finish the checkout in Swiss Francs or Euros: How to order.
  • After your payment has been received, you will be provided with an access code to your course materials.
  • You will be guided through the topics in 118 minutes (split into 14 tutorials and Q&A's) and will get a basic understanding of Regulatory Affairs.
  • The online seminar remains activated for 30 days. This means you can view the content at your own pace and repeat important topics.
  • You will have the opportunity to download further information as well as a list of references used for this course.
  • This course includes NO consultation. You can either book an online consultation separately or, alternatively, purchase this course to include consultation (you will need to update your shopping cart).
CHF 270.00

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