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The First Ten Years of the Paediatric Regulation

The First Ten Years of the Paediatric Regulation
Your first opportunity to hear the findings of the report of the European Commission’s consultation reviewing 10 years of the European Paediatric regulation and to hear about the possible future regulatory proposals.


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Programme developed in cooperation with the European Commission

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To mark ten years since the Paediatric legislation entered into force, the European Commission (EC) launched a public consultation to get views and feedback from stakeholders, to support the Commission in drafting its second report on the Paediatric Regulation. The objective of the regulation is to improve the health of children in Europe by facilitating the development and availability of age-appropriate medicines for children, and by increasing available information on the use of medicines for children.

The feedback received forms an integral part of the Commission's final report assessing the impact of the Paediatric Regulation on public health and the pharmaceutical industry (external link), which was published on 26 October 2017. Copies of the Commission report will be available at the conference.

Before the Paediatric Regulation came into effect in 2007, many medicines authorised in Europe were not studied adequately or authorised in children. This caused difficulties for prescribers and pharmacists treating children, as well as for their patients and carers.

The Regulation introduced sweeping changes into the regulatory environment for paediatric medicines, designed to better protect the health of children in the EU. The main change was the creation and operation of the Paediatric Committee to provide objective scientific opinions on paediatric investigation plans (PIPs), development plans for medicines for use in children.

It is essential for regulatory professionals to keep abreast of these developments as no new drugs can be registered in the EU without a PIP being approved or a waiver/deferral by the EMA’s Paediatric Committee.

This conference includes a Keynote speech by Commissioner Vytenis Andriukaitis - Health & Food Safety, European Commission, followed by European Parliament MEP Françoise Grossetête.

Speakers from the EU Commission, EMA, PDCO chair (PEI, Germany), patient groups, EFPIA, consultants engaged by Commission for report and international view will cover:

Findings of the report 
Economic impact
The Industry view
The Patient view
The International view – FDA/EMA in close cooperation on paediatrics

There will be ample time to debate in an extended panel session for which questions will be invited in advance from delegates.


Who should attend:

Senior and middle management  regulatory staff.  Heads of regulatory affairs, directors of regulatory policy/intelligence, senior management, CEOs , Research and Development,  Regulatory staff involved in paediatrics, Patient groups, Regulatory Agencies, Law firms, paediatric research networks, SMEs

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Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.

Conference Price (£):
Member: £550 + VAT
Non-member: £675 + VAT

Those working for regulatory agencies or government agencies or academic institutions: 
Member: £412.50 + VAT
Non Member: £506.25 + VAT
Those working for charities or SMEs:
Member: £275 +VAT
Non Member: £337.50 + VAT

Those working for patient groups:
£135 + VAT

Bulk booking discounts are also available. 

For the discount codes please contact meetings@topra.org

- Please note the number of discounted places may be limited.
- All fees are shown in Pounds Sterling and do not include VAT 
- Fee excludes accommodation and travel. The delegate ticket includes refreshments at coffee breaks and buffet lunches (if applicable).

Pullman Brussels Centre Midi Hotel BRUSSELS BELGIUM
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