Leistungen
The Company will subcontract Contract Research Organization (CRO) necessary for: - thorough review of the studies performed by the company and GUMed focused on the generation of the most completed version of IMPD and other documents necessary for registration and MAA, - thorough review of GMP procedures in manufacturing of the TREGS preparation, - presumptive plan of the phase III study to be presented to the Committee on Advanced Therapies EMA during consultations, - the preparation of documents directly necessary for scientific advice.
Final EMA guidelines on MAAPolTREG will dialogue with EMA officials in order to obtain guidelines on MAA Scientific advice helps to ensure that developers perform the appropriate tests and studies so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketingauthorization application
Completed package of the PolTREGdocuments for scientific adviceThe Company in cooperation with CRO will prepare documentation in accordance with EMA procedure. Main activities will include preparation and submitting: - letter of intent, - brief description of TREG therapy under development, - initial proposal of the TREG development programme (starting from phase III of clinical studies), - PolTREG’s questions and positions on the appropriate tests and studies in the phase III of clinical studies, - previous results of studies and publications.
Suche nach OpenAIRE-Daten ...
Bei der Suche nach OpenAIRE-Daten ist ein Fehler aufgetreten
Es liegen keine Ergebnisse vor