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").

Summary of results(28 KB)

Comments received during a 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
• Anonymous

 

• Medicines for Children