The European Medicines Agency plays an important role in the development of medicines for children. In the past, many medicines authorized in Europe were not studied adequately or authorized in children. This caused difficulties for prescribers and pharmacists treating children, as well as for their patients and careers.
To help to solve this problem, the European Union’s Paediatric Regulation gave the EMA new responsibilities in 2007. These responsibilities allowed the EMA to stimulate research into the uses of medicines in children and to lead to their authorization in all ages. The Paediatric Regulation’s main aim is to improve the health of children in Europe without subjecting children to unnecessary clinical trial directive, or delaying the authorisation of medicinal products for use in adults.
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 directive clinical trials have 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:
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
Timing of the PIP
Results of the legislation
Who Will Benefit:
Regulatory Affairs Personnel
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 for four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom.
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