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Paediatric Investigation Plans (PIP)

May 13 2014 8:00AM - May 14 2014 5:00PM | Millennium Gloucester Hotel London Kensington 4-18 Harrington Gardens London SW7 4LH United Kingdom

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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 will be discussed. Case-studies and instructor-led group work on specific cases will be presented.

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 the participants from previous PIP courses say:

"Workshop and case studies were very appropriate to put in practice the information learned in the course, coverage of all main topics of Paediatric Regulation was excellent"

"Very knowledgeable and good instructors, great course"

"I appreciated the real-life examples brought up – the more the better!"

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: Beginner/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

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

Hotel & Travel 

The course will take place at:

Millennium Gloucester Hotel London Kensington
4-18 Harrington Gardens
London, SW7 4LH
Tel: +44 20 7373 6030
Fax: +44 20 7373 0409
Email: reservations.gloucester@millenniumhotels.com

 

After 31 March the hotel rooms are subject to availability. Please contact the hotel for availability and prices.

Contact Information 

DIA Europe
Kuechengasse 16
4051 BASEL
SWITZERLAND

TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52
E-MAIL: diaeurope@diaeurope.org

Faculty 

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Agenda  

Day 1 Tuesday, May 13, 2014

  • 8:00AM - 9:00AM

    REGISTRATION
  • 9:00AM - 10:30AM

    Session 1: INTRODUCTION AND DEFINITIONS
  • 10:30AM - 11:00AM

    COFFEE BREAK
  • 11:00AM - 12:30PM

    Session 2: THE PIP LIFECYCLE: PART 1
  • 12:30PM - 1:30PM

    LUNCH
  • 1:30PM - 2:15PM

    Session 2 continued: THE PIP LIFECYCLE: PART 1
  • 2:15PM - 3:00PM

    Session 3: THE PIP OPINION
  • 3:00PM - 3:30PM

    COFFEE BREAK
  • 3:30PM - 4:45PM

    Session 4: THE PIP LIFECYCLE: PART 2
  • 4:45PM - 5:30PM

    GROUP WORK
  • 5:30PM - 6:30PM

    DRINKS RECEPTION

Day 2 Wednesday, May 14, 2014

  • 8:30AM - 9:00AM

    Session 4 continued: THE PIP LIFECYCLE: PART 2
  • 9:00AM - 10:00AM

    Session 5: SPECIAL ISSUES
  • 10:00AM - 10:30AM

    COFFEE BREAK
  • 10:30AM - 11:30AM

    Session 5 continued: SPECIAL ISSUES
  • 11:30AM - 1:00PM

    Session 6: WORKSHOP ON CASE STUDIES: PART 1
  • 1:00PM - 2:00PM

    LUNCH
  • 2:00PM - 3:30PM

    Session 7: WORKSHOP ON CASE STUDIES: PART 2
  • 3:30PM - 4:00PM

    COFFEE BREAK
  • 4:00PM - 4:30PM

    Session 8: COURSE SUMMARY
  • 4:30PM - 5:00PM

    COURSE ASSESSMENT

Registration Fees 

Member

Charitable Nonprofit/Academia Member
€710.00
Member Government
€710.00
Member Standard
€1420.00

Non-Member

Charitable Nonprofit/Academia Nonmember
€840.00
NonMember Government
€840.00
NonMember Standard
€1550.00
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