WitrynaDossier (IMPD) for a Cell Therapy Medicinal Product. It should be used as a guidance to write an IMPD according to the template published on the website of the CCMO. WitrynaGuideline on the requirements for the chemical and p harmaceutical quality documentation concerning investigational medicinal products in clinical trials

Investigational medical product dossier

WitrynaThe eCTD format is mandatory to use for all submission types related to Marketing Authorisation for products within all EU procedures (i.e. Centralised, Decentralised … WitrynaAn IMPD is one of the essential documents that form the CTA submitted to the EU Competent Authorities (CAs) for non-authorized IMPs. Where the IMP is subject of a marketing authorization, the Summary of Product Characteristics, complemented by additional data as necessary, could be submitted in lieu of the IMPD. Other glossary … fit for duty certification

Investigational Medical Product Dossier, IMPD Dossier, Europe

WitrynaThe IMP dossier (IMPD) • Quality data • Non clinical data (module 4 CTD) • Clinical data (module 5 CTD) • B/R analysis - Content adapted to the level of knowledge (phase of … Witryna5. Essential information for the use of the medicine (1/2) The therapeutic indication(s) of the medicine is given in section 4.1, in defining the target disease and the population to benefit from the medicine The dose is specified in section 4.2 “Posology and method of administration” for each indication(s) and each relevant subpopulation (e.g. … WitrynaDetailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products … can hep c resolve