Enpr-EMA (European Network of Paediatric Research at the European Medicines Agency) Working group on public-private partnership offers the possibility to get advice and information during all stages of paediatric medicines development and in particular at an early stage in the product development process, including PIP preparation.
Enpr-EMA suggests that all companies consider using these opportunities in a spirit of shared learning about the best way to collaborate during PIP planning.
The offer proposes to assist companies that thus can take advantage of the scientific and logistical expertise in paediatric clinical research, available from the paediatric clinical research networks members of Enpr-EMA.
TEDDY Network is a category 1 network member of Enpr-EMA, and offers its support in this advisory action, making available its long-lasting experience in paediatric clinical research management as well as its methodological expertise to set up, develop and conduct paediatric multinational clinical trials.
This offer is suitable to all organizations and companies including those operating outside Europe if applicable according to local regulations and company rules. Paediatric research network expertise is available for the entire drug development cycle; therefore, this offer covers the whole drug development process – from scientific idea to clinical studies of the PIPs and safety follow-up after Marketing Authorization. The offer includes four different time points with detailed consultation issues at each point. These right time consultations can offer key benefits for companies by:
- meeting the patients’ needs, with a targeted and evidence based feasibility
- enhancing the product development process by helping to create a relevant drug development plan
- optimising the PIP development focusing on key studies and developing a long-term strategy
- making an efficient clinical trial conduction – saving time and costs
You may check the current paediatric research networks availability, and the services offered by these networks by visiting the Enpr-EMA database: http://enprema.ema.europa.eu/enprema/. To contact these paediatric research networks of the Enpr-EMA, send an e-mail to enprema@ema.europa.eu
More information is available at this link.