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Paediatric Investigation Plans (PIP)

Nov 28 2013 8:00AM - Nov 29 2013 5:00PM | Mercure Paris la Villette 216 Avenue Jean Jaures 75019 Paris France

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Overview 

Overview of the Paediatric Investigation Plan (PIP) procedure, including in-depth discussion of specific scientific/regulatory issues in relation to PIPs, case-studies and instructor-led group work on specific cases.

This course will provide a full introduction to PIPs and the EU Paediatric Regulation. The course faculty are European-based leading experts from EMA and industry. Topics will be presented through interactive lectures and hands-on workshop training.

What You Will Learn 

  • EU paediatric regulation
  • PIP lifecycle
  • How to get your PIP approved
  • PIPs after approval

Who Should Attend 

Professionals in regulatory affairs, clinical research, project management, toxicology, product development. Participants should preferably have a fair understanding of aspects of paediatric medicines development.

Level: Intermediate

Learning Objectives 

At the conclusion of this course, participants should be able to:

  • Describe the EU paediatric regulation
  • Discuss the PIP approval procedure
  • Identify the expectations and requirements from the Paediatric Committee (PDCO)
  • Demonstrate how to prepare a PIP eligible for evaluation by PDCO
  • Explain the modification of an agreed PIP procedure
  • Describe the compliance check procedure
  • Demonstrate an overview of procedures after initial PIP approval

Hotel & Travel 

The DIA has blocked a limited number of rooms at the following hotel:

Mercure Paris La Villette
216 Avenue Jean Jaures
75019 - Paris
France

Tel. : +33 (0)1 44841818
Fax : +33 (0)1 44841820

Email: mercureparisv@alliance-hospitality.com
Website: http://www.mercure.com/de/hotel-8816-mercure-paris-la-villette/index.shtml

at the rate of:
140.00 EUR per single room per night inclusive of breakfast.

To make your reservation, please use this booking form and mail it directly to mercureparisv@alliance-hospitality.com

Important: Please complete your reservation by 8 October 2013. Reservations received after this date will be subject to hotel availability and room rate may vary.


 

Contact Information 

DIA Europe
Kuechengasse 16
4051 Basel, Switzerland
Tel.: +41 61 225 51 51
Fax: +41 61 225 51 52
Email: DIAEurope@diaeurope.org

Faculty 

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Registration Fees 

Member

Member Academia
€683.00
Member Government
€683.00
Member Standard
€1365.00

Non-Member

NonMember Academia
€798.00
NonMember Government
€798.00
NonMember Standard
€1480.00
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CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

  • Industry (Member/Non-member) = €200.00
  • Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
  • Tutorial cancellation: €50.00

If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

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