A professional introduction to the topic of Regulatory Affairs for career starters or career changers covering a variety of sectors, from pharmaceuticals and medical devices to chemicals. This course is for you if you are looking for your first job and want to systematically expand your interest in Regulatory Affairs—and document it with a certificate on your CV.

Key Highlights:

All in-person trainings allow for direct interaction and question-answering. Unlike many others, you’ll solve relevant case studies using my over 25 years of industry experience. This deepens your understanding of Regulatory Affairs and provides practical experience. What to expect? Here is an example on LinkedIn.

What You Get:

• 5 webinars of 1.5h each
• 5 case studies to work on independently, with individual analysis and feedback on the solution

Curriculum (Excerpt)

You can find the full overview here.

Module 1: Fundamentals Part 1

• Introduction: Why is Regulatory Affairs important for society?
• The market sizes and R&D expenses for product development
• Core tasks of a Regulatory Affairs department
• ...

Module 2: Fundamentals Part 2

• Tasks of the regulatory authorities
• The authorization dossier
• The structure of regulations
• ...

Module 3: Pharmaceuticals

• Authorisation procedures for new products
• Variations: life-cyle management of existing authorisations
• ...

Module 4: Plant Protection Products

• Validity, effort, and cost for the authorisation of plant protection products
• Authorisation of an new active substance,
• Dossier structure
• Product authorisation
• ...

Module 5: Medical Devices and IVDs

• Definitions of Medical Devices and In-vitro Diagnostic Devices
• Key Principles of the Regulations
• Notified Bodies and Conformity Assessment
• ...

Process

• You complete the checkout in Swiss Francs or Euros and receive an invoice: How to order.
• After receiving your payment, you will receive a message with further information.
• You have the option to download additional information as well as a list of references used for this course.
• Additionally, you will get my email address and can - if desired - ask in-depth questions about the content.
• We will jointly arrange the training sessions in a 1:1 setting or smaller groups of up to 8 people.

For Companies and 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.