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Webinar on Orphan Medicinal Product Designation in the EU
The European Medicines Agency plays a central role in the development and authorization of medicines for rare diseases. These medicines are termed ‘orphan medicines’ in the medical world.
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. Patients suffering from rare conditions should be entitled to the same quality of treatment as other patients.
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.
In this Webinar the process for obtaining designation is explained in detail. There are many factors to consider when preparing an application, and taking those into account will ensure a smooth process. The main factors to consider are:
- Definition of a medical condition
- Dealing with subsets
- How to show significant benefit
Areas Covered in the Session:
- Legal background
- The COMP
- Criteria for designation
- How to describe the medical condition
- How to deal with subsets
- Significant benefit
- Timing of designation
- Procedure for obtaining designation
- Guidelines for Marketing Authorization procedures
- Determinants for successful Marketing Authorizations
Who Will Benefit:
- Regulatory Affairs personnel
- Senior management
- Project Managers
- Medical writers
- CRAs and CRCs
- QA / Compliance personnel
- Clinical Research Scientists
- QA / QC Auditors and Staff
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 during four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom.
NetZealous - Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
Event Link : http://bit.ly/Orphan-Medicinal-Product-Designation-in-the-EU
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