12/03/25

Join this Startlife workshop to deepen your regulatory knowledge, ask questions directly to an industry expert, and ensure your product is on a solid path towards market compliance.

📆 12 March 2025, 15:30 – 17:00 (CET)

📍Online or in person. Room Opportunity, Wageningen Campus, Bronland 10d, 6708 WH Wageningen, Netherlands. You will receive the Zoom link in your email after registering for the event.

The workshop will cover the following key topics:

1. Product Qualification: In or Out Scope of Prior Market Authorisation Requirements?

Understanding the criteria: Learn to identify which criteria determine if a product requires prior market authorisation.
Assessing your product: Understand how to evaluate whether your product falls within the scope of regulatory oversight.

2. Regulatory Requirements: If In Scope, What Does This Entail?

Detailed overview: Gain insight into the necessary steps and documentation for compliance if your product requires authorisation.
Ensuring compliance: Learn the process and best practices to meet regulatory standards effectively.

3. Real Life Examples Based on Member State Consultations

Case studies: Explore real-world examples from various Member States.
Lessons learned: Understand common pitfalls and successful strategies implemented by others.

4. What’s in a Name? Considerations on the Naming of New Proteins Based on Recent ECJ Case Law

Recent ECJ caselaw: Review and interpret relevant European Court of Justice rulings on naming conventions.
Practical implications: Understand how these decisions affect branding and naming strategies for new proteins.

By the end of this workshop, you will:

Have a good assessment of when in the R&D process regulatory topics should be considered.
Understand the initial steps to take for integrating regulatory considerations into their product development.

Speaker & Q&A: Karin Verzijden – Life Sciences Lawyer at Axon Lawyers

For more information and registration, please visit the event webpage.

door Dina Diek