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 Regulatory Affairs 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

Online Consultation

• After completing the online seminar, you can arrange a call with Thorben Bonarius to discuss your "homework" if you wish.
• You can also ask any questions related to the content of our Introductory Course.
• You may also send him your questions/documents in advance.

• 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.
• You will receive an e-mail address and can - if desired - ask in-depth questions about the content.
• You arrange a meeting using Calendly and receive 45 minutes of individual consultation over Google Meet.

For Organisations

This introductory course can be also presented in person by Thorben Bonarius as an in-house seminar and can be accompanied by workshops. For inquiries, please use the contact form.