Medicinal products for human use
Medicines for children - PIP Guideline
Results of public consultation in preparation of the "Communication from the Commission - Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on the criteria for assessing significant studies" ("PIP Guideline").
A summary of the responses is available here.
Below are the public responses to the above-mentioned public consultation.
- AIPES - Association of Imaging Producers & Equipment Suppliers
- Astellas Pharma Europe BV
- BfarM - Bundesinstitut für Arzneimittel und Medizinprodukte
- BIA - BioIndustry Association
- BPI - German Pharmaceutical Industry Association
- EFPIA - European Federation of Pharmaceutical Industries and Associations : 1 - 2
- EMEA - European Medicines Agency
- GCPA - Good Clinical Practice Alliance
- ICR - Institute of Clinical Research
- IPFA - International Plasma Fractionation Association
- MCRN - Medicines for Children Research Network
- PhRMA - Pharmaceutical Research and Manufacturers of America
- Pierre Fabre Medicament
- PRC - Paediatric Research Consultancy (Jane Lamprill)
- TEDDY network
- Voisin Consulting