ComplianceOnline, Online Event
2013-01-22
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
- Incentives
- 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
- Quality
- Clinical
- Manufacturing
- Supply Chain
- Import / Export
- Global Business Development
- General Management
- Administrative Staff
- Documentation
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Invited Speakers:
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Damien, has worked in the pharmaceutical industry for over 18 years, first as a pharmaceutical technician, and then as an academic research manager at SmithKline Beecham before completing his university education. Damien graduated from the University of Bradford School of Pharmacy in 2000 and has a Master’s degree in the Frontiers of Medical Science. He has since pursued his career in the development of novel drug/biological products. Damien started his post-university career working at Covance, a global contract research organization. He worked in the global consultancy division in the area of emergent product services, specializing in defining markets and regulatory/ development strategies for novel pharmaceutical and biotechnology products. In 2004, Damien became an independent consultant in this area, specializing in working with virtual and small drug development companies.
His work has seen him frequently working with regulatory agencies across the globe in order to fast-track products into Man, he develops strategies and works within the regulatory structures of the FDA, EMA, MHRA and Health Canada, amongst others. Damien also organizes courses on The Regulations of First in Man Clinical Trials and Business Planning for MedTech Entrepreneurs.
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