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Seminar 5: Specific considerations for the development and authorization of medicinal products for children


Course Description

CONTENT

The new legislation on the development and authorization of medicines for use in children aged 0 to 17 years was introduced in the European Union in January 2007. The Paediatric Regulation (Regulation/EC No 1901/2006 as amended) affects the regulatory environment for pharmaceutical companies and agencies enormously since it required many new tasks and responsibilities for the authorities, mainly the EMEA, and remarkable new requirements for the overall development plans of medicinal products for all types of pharmaceutical companies. Seminar 5 is designed to provide comprehensive information on the new European requirements for medicines for children, the legislation, regulatory bodies and procedures and their practical implementation in the daily work of a pharmaceutical company. In addition to the European requirements on the development of medicines in children the regulations of the FDA and of other regions are dealt with in detail.

TOPICS COVERED

- Background of development and content of the Paediatric Regulation No 1901/2006 EC
- The role of the EMA and of the Paediatric Committee (PDCO)
- The Paediatric Investigational Plan (PIP) (Scope, legal aspects, considerations for developing and executing the PIP, Preparation of the PIP)
- Requirements on paediatric drug formulations
- Juvenile Animal Studies
- Implications of the EU legislation for the pharmaceutical industry: perspectives, challenges and opportunities
- Other regions, focus on US

LEARNING OBJECTIVES

- Understand the requirements and principles of authorization of medicinal products for use in children
- Learn the key strategic considerations and their implications on the general strategy of a company followed in their development programme
- Understand the details of the regulatory procedures to follow and the stake holders involved
- Understand the issues to be considered in the planning of the paediatric development programme
- Develop the appropriate regulatory strategy for the Paediatric Investigation Plan (PIP)
- Prepare a PIP successfully

AGENDA

Day 1, Thursday, 29 April 2015

09.15 - 09.30 Welcome and introduction (Avril Mankel, Santen GmbH)

09.30 - 10.30 Preparation of the Paediatric Investigation Plan (PIP) (Avril Mankel, Santen GmbH)

Format
Application - incl. Application for PUMA (Paediatric Use Marketing Authorisation)
Regulatory procedure for the PIP assessment by the PDCO
EMA Paediatric Team: roles and responsibilities during the assessment vs. PDCO

10.30 - 11.00 Coffee Break

11.00 - 12.00 continued (Avril Mankel, Santen GmbH)

12.00 - 13.00 Lunch

13.00 - 15.00 EMA and the Paediatric Committee (PDCO) (Daniel Brasseur, former PDCO Chair- CHMP member)

Role, function, procedures and decision-making
Interactions with other EMA’s committees and working parties

The scope of the Paediatric Investigation Plan (PIP)

Waivers (incl. class waivers), deferrals
Indications and conditions
Regulator’s experience with Articles 7 & 8
Opinions and decisions on PIP applications
Considerations for obtaining scientific advice

List of paediatric needs and priority list of off-patent medicines

Publication of clinical trial results

Development of regulatory guidelines on considerations of drug development in children

15.00 - 15.30 Coffee Break

15.30 - 17.15 Considerations for developing and executing the PIP (Ashley Strougo, Astellas Pharma Global Development Europe)

Clinical trials (Criteria and decision-making on First in Child studies, EudraCT)
PK modelling and extrapolation

Paediatric Networks

17.15 – 18.15 Requirements on paediatric drug formulations (Jörg Breitkreutz, University of Düsseldorf)

18.15 End of Day 1

18.45 Get-together with food and wine

Day 2, Friday, 30 April 2015

09.15 - 11.00 PIP-related legal aspects (Geneviève Michaux, Counsel at Hunton & Williams)

Legal aspects related to Article 7 & 8 under the global marketing authorisation concept
Compliance checks
Rewards for paediatric data
National Patent Offices

11.00 - 11.30 Coffee Break

11.30 - 13.00 Juvenile animal studies (David M. Cross, Cross Pharma Consulting Limited, formerly Pfizer Global Research and Development UK)

13.00 - 14.00 Lunch

14.00 - 14.45 The EU Regulation No 1901/2006 on medicinal products for paediatric use – the Paediatric Regulation (Koen Crombez, Merck Sharp & Dohme (Europe), Inc.)

Implementation of the Paediatric Regulation and Commission PIP guideline

14.45 - 15.45 Regulation for medicines in children in other regions with focus on the US (Koen Crombez, Merck Sharp & Dohme (Europe), Inc.)

15.45 - 16.15 Coffee Break

16.15 - 17.00 Implications of the EU legislation for the pharmaceutical industry: Perspectives, challenges and opportunities (Koen Crombez, Merck Sharp & Dohme (Europe), Inc.)

17.00 - 18.00 Case illustrating PIP practice with discussion (Koen Crombez, Merck Sharp & Dohme (Europe), Inc.)

18.00 End of Seminar 5

Entry Requirements

English language knowledge

Course Fees

1.400 EUR regular fee, 920 EUR for academic institutions/government (+19% German VAT)


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Recipient: European Centre of Regulatory Affairs, EUCRAF

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