Paediatric Drug Development - Free Online Resource Center
The Paediatric Drug Development Resource Center covers an entire host of topics, ranging from
- Implementation lessons about the consistency Paediatric Interventional Plans
- Learning from across different therapeutic areas
- PIP submission updates
- Effectively managing risks to stop expensive prolonged commitments
- Integration of non-clinical studies into the drug development process
- Incorporating the results of toxicity studies in juvenile animals
Legal and Regulatory Issues in Paediatric Drug Development (PDD)
How to comply with FDA and EMA
PDD regulation is different in the EU and the US but there are major overlaps in regulatory atitudes and intent.
Clinicians and paediatric advisory boards need to be set up early in the process to ensure that the appropriate strategy is developed and executed and the process becomes transparent for all stakeholders.
There is an in-depth analysis of the situation and the recommended approach by Dr. Klaus Rose is CEO a PDD consultancy in Switzerland.
Take a look at the presentation here (How to comply with FDA and EMA)
Paediatric trials around the world
Another analysis takes a look at the development of Paediatric Drug Development across the globe over the past 15 years.
Safety is a major concern for all regulatory agencies across all countries. Legistlation specifies mandatory, detailed reguation for trials
The author also look at simulation and modeling in medical trials, their usefulness and the ability of researchers to collect sufficient data to make reliable decisions.
View the article here (Pediatric trials around the world)
Global Paediatric Studies – a CRO perspective
Did you know?
- Pediatric Research Equity Act (PREA) Applicable to all NDAs and BLAs is different from Paediatric Investigation Plan (PIP) needed for all marketing authorisation applications?
- Drugs for the US and North marerican markets may need to comply with PREA requirements. But for the EU marketing authorization, PIP may not be necessary.
- On the other hand products developed for the European Union market may require paediatric studies if they are to be marketed in the US.
Paediatric Drug Development Conferences
The next conference on Paediatric Drug Development where you can learn more about the topic and benchmark your own company or institution will be held in Germany: 4th International Congress Integrated Paediatric Drug Development; 10 - 12 December, 2012.
Check Out the Agenda