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Regulation of Advanced Therapy Medicinal Products in Europe
Tuesday, January 22, 2013 from 10:00 AM to 11:00 AM (PST)
Palo Alto, CA
This webinar will discuss the regulation of advanced therapy medicinal products (ATMPs) in Europe, the 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.
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
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.