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Orphan Medicinal Product Designation in the EU - By Compliance Global Inc.
The European Medicines Agency plays a central role in the development and authorisation of medicines for rare diseases. These medicines are termed ‘orphan medicines’ in the medical world.
The EMA is responsible for reviewing applications from sponsors for the designation of medicines for rare diseases.
Why Should You Attend:
Orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect no more than 5 in 10,000 people in the European Union.
Designation as an orphan medicinal product in the EU has important advantages. Sponsors who obtain orphan designation benefit from a number of incentives, including protocol assistance, a type of scientific advice specific for designated orphan medicines, fee waivers or reductions for the regulatory procedures or a 10 year market exclusivity once the medicine is on the market. Therefore, it is important for companies to know the process for designation.
Areas Covered in this Webinar:
The Webinar will start with an introduction. It is estimated that today in the EU, 5-8000 distinct rare diseases affect 6-8% of the population - about 30 million people. Rare diseases are defined as life-threatening or chronically debilitating conditions that affect no more than 5 in 10,000 people in EU. This is equivalent to around 250,000 people or less for each disease.
These conditions occur so infrequently that the cost of developing and bringing to the market a medicinal product to diagnose, prevent or treat the condition would not be recovered by the expected sales of the medicinal product.
- What designation as an orphan medicinal product means?
- What benefits the designation has?
- How to obtain designation?
Who Will Benefit:
- Regulatory affairs officers and managers
- Clinical trial associates
- Clinical operations personnel
- Product development personnel
- Personnel in the pharmaceutical and biotech industries who need a thorough understanding of the regulatory issues involved in the development of new medicinal products within the European Union
Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands. He is currently Director Regulatory Affairs at CATS Consultants. Until March 2004, he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003, he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked for four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom.
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There may be many networking opportunities at the Orphan Medicinal Product Designation in the EU - By Compliance Global Inc.. Find out more in the event details below.
Clinical trial associates
Clinical operations personnel
Product development personnel
Personnel in the pharmaceutical and biotech industries who need a thorough understanding of the regulatory issues involved in the development of new medicinal products within the European Union
Compliance Global Inc.
Compliance Global Inc. http://www.seatradecruiseglobal.com/sponsorship-opportunities
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