Why Should You Attend:
With the EU centralizing the regulation of technologies used for advanced therapy medicinal products at all stages of development to some extent or another, it provides a great opportunity for US based companies to have their development validated at an early stage for acceptance to the market, the route through local regulation on clinical studies smoothed and product registration managed centrally at a reduced fee.
This webinar will discuss the regulation of advanced therapy medicinal products (ATMPs) in Europe, the role and structure of the Committee of Advanced Therapy (CAT), the regulatory structure of the Committee on Human Medicinal Products (CHMP) and how they can benefit your technology.
Understanding the process and procedures that the CAT go through companies with relevant technologies in both the USA or Europe can add considerable value to your IP packages, guide your way through the regulations and ensure the route to clinical trial acceptance is smoothed for some very challenging and ill understood technologies.
Areas Covered in the Seminar:
- CAT and ATMP Structures
- Which technologies are covered
- Classification procedures
- Non-clinical studies
- Clinical Studies
- Certification of development work
- Hospital Exemptions
- An overview of CMC requirements
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in medical technology companies (USA and EU based companies) with products in development.
- Regulatory Affairs
- Supply Chain
- Import / Export
- Global Business Development
- General Management
- Administrative Staff