2012 annual workshop on the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)

• Date:
  Thursday, 22 March 2012, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

Day one of the workshop is being organised with the assistance of The Organisation for Professionals in Regulatory Affairs and is an open meeting for all stakeholders: patient/parentorganisations, network representatives, pharmaceutical industry staff responsible for paediatric studiesand regulators. Day two on the 23 March is being attended by members of the Enpr-EMA network and the European Medicines Agency and is invitation-only.

Documents

Agenda – Annual workshop on the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)

Reference Number: EMA/39173/2012

Report on annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), 22-23 March 2012

Adopted Reference Number: EMA/218181/2013 Summary:

On 22 & 23 March 2012 the European Medicines Agency (EMA) convened the annual two-day workshop of the European network of paediatric research at the EMA (Enpr-EMA). Enpr-EMA is a network of research networks, investigators and centres with recognised expertise in performing clinical studies in children, with the aim to foster high-quality ethical research on quality, safety and efficacy of medicines to be used in children.

Presentation - Industry proposals: How to interact with and use EnprEMA (Ali Harrison, AstraZeneca)

Presentation - The interface: Industry – CRO - Clinical trials networks (Andrew Rose, MCRN)

Presentation - Break out session 1 - Proposals on how to develop and foster new networks (Peter Helms, chair of EnprEMA CG)

Presentation - Break out session 2 - Proposals on how to encourage clinicians to participate in clinical trials Proposals on how industry can refer and use networks (Saskia de Wildt, MRRN-NL)

Presentation - Break out session 3 Proposals on how patients can be involved in networks (trial design etc) and in trials (Elizabeth Vroom, Duchene Parent Project and Juan Garcia Burgos, EMA)

Presentation - European Network for Hyperkinetic Disorders (Dave Coghill, University of Dundee)

Presentation - SME experience with EnprEMA (Helen Shaw, Proveca Ltd)

Presentation - Setting up a Young Person’s Advisory Group (Jenny Newman, MCRN)

Presentation - EnprEMA (Jose Drabwell, IPOPI)

Presentation - Network's perspective - What networks can offer (Kalle Hoppu, FINPEDMED)

Presentation - The interface between Industry – CRO and Clinical Trials Networks: Defining the roles (Martine Dehlinger-Kremer, RPS Inc. / EUCROF)

Presentation - Paediatric Rheumatology InterNational Trials Organization (Nicola Ruperto, PRINTO)

Presentation - Emerging networks: Learning from successful networks (Tim Lee, European Cystic Fibrosis Society Clinical Trials Network)

Presentation - EuroNeoNet