Join this 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.
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:
Speaker & Q&A: Karin Verzijden – Life Sciences Lawyer at Axon Lawyers
Hope to see you there!
