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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.
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
• EMA/PDCO view
• 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.
- Chair: Professor Daniel Brasseur - former first chair of European Medicines Agency Paediatric Committee (PDCO), Belgium
- Florian Schmidt, Deputy Head of Unit, European Commission, DG SANTE/B5
- Peter Varnai - Principal, Health & Life Sciences, Technopolis group, UK
- Dirk Mentzer - Head of Pharmacovigilance, Paul-Ehrlich-Institut, Germany and chair PDCO
- Ralph Bax - EMA
- Geneviève Le Visage - vice-chair Paediatrics WG, EFPIA
- Delphine Heenen - Managing Director, KickCancer, member of Unite2Cure, Belgium
- Pamela Dicks - representative of eYPAGnet (European YPAG network)
- Mark Turner - Senior Lecturer in Neonatology, University of Liverpool, Chair, European Network of Paediatric Research at the European Medicines Agency
- Sandra L. Kweder - Deputy Director, Europe Office, Office of International Programs, U.S. Food and Drug Administration
- Françoise Grossetête, MEP
- Commissioner Vytenis Andriukaitis
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
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