developed in cooperation with the European Commission
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, which is due to be published late September/October 2017.
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.
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 ROSSETÊTE.
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.
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
To register, please log in or create an account
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 firstname.lastname@example.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).