Paediatric Clinical Trials

Posted: 6 March 2018 | | No comments yet

When designing a Paediatric clinical trial, a paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children…

Paediatric Clinical Trials

All applications for marketing authorisation for new medicines have to include the results of studies as described in an agreed PIP, unless the medicine is exempt because of a deferral or waiver. This requirement also applies when a marketing-authorisation holder wants to add a new indication, pharmaceutical form or route of administration for a medicine that is already authorised and covered by intellectual property rights¹.

Join the likes of Amgen, AstraZeneca, European Medicines Agency, GSK, MHRA, Pfizer, Roche, University of Liverpool and many more at the industry’s leading paediatric clinical trials event to where Paediatric Investigation Plans (PIP) will be one focus, along with a closer look at some of the other trending topics facing the market.

There will be coverage of PIP in the Keynote Session on Day 1 at 16.00, which is hosted by Mark Turner, Chair European Network of Paediatric Research, Senior Lecturer in Neonatal Medicine at the European Medicines Agency and University of Liverpool.

There will also be a Panel Discussion about the effects PIP’s had on quality of paediatric clinical trials and has this translated into greater efficiency in access to new approved medicines. This will be at 16.40 on Day 1 in the Panel Debate titled – Paediatric Medicine Regulation in the EU: What are the Challenges and Opportunities 10 Years on.

Lastly, there is the conference Workshop – This year’s event contains a workshop on the 21 March 2018 covering a number of areas, including a look at: Do I Need a PIP, What Should the PIP Cover, Procedures and Rewards. The Workshop will be hosted by Genevieve Michaux, Member of the Brussels and Paris Bar, Partner at Mayer Brown Europe-Brussels LLP.

For the latest news, information and for easy registration, please visit the event website at:

For sponsorship packages and delegate bookings, please contact: Alia Malick at [email protected] or call +44 (0)20 7827 6168

You can email the booking form to the events team at: [email protected] or Fax to: +44 (0)870 9090 712

¹Source: European Medicines Agency 2018.

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