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Compliance Global Inc
2754 80th Avenue
New Hyde Park, NY 11040
(516) 900-5515

Event Description


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

Learning Objectives:

  • Paediatric Legislation
  • The PDCO
  • The COMP
  • PIP's
  • Timing of the PIP
  • Incentives
  • Application procedure
  • Results of the legislation

Who Will Benefit:

  • Regulatory Affairs Personnel
  • Senior Management
  • Project Managers
  • Medical Writers
  • CRAs and CRCs
  • QA / Compliance Personnel
  • Investigators
  • Clinical Research Scientists
  • QA / QC Auditors and Staff
  • Consultants

Speaker Profile:

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.

For more detail please click on this below link:

Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Fax: +1-516-900-5510

Don't wait to register for the Pediatric Investigation Plans (PIP) in the EU- By Compliance Global Inc.. You'll meet influential people and maximize your opportunities for success. Start now by accessing the information below.

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Event Details

Conference/Event Dates: 07/05/2016 - 07/05/2016
Conference/Event Hours: 1:00
Classification: B2B
Primary Industry: Clinical Pharmacology
Other Industries: Clinical Pharmacology, Pediatrics, Professional Healthcare
Cost to Attend: Live Session for one participant Price: $175.00
Audience: Regulatory Affairs Personnel
Senior Management
Project Managers
Medical Writers
CRAs and CRCs
QA / Compliance Personnel
Clinical Research Scientists
QA / QC Auditors and Staff
Show Owner:Compliance Global Inc.
Sponsorship: Yes
Sponsorship Details: Compliance Global Inc.

Booth Details

Booth Size Booth Cost   Available Amenities
No Exhibiting   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: n/a
Other Booth Sizes Available: n/a

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