1 What is required for first into man? The EU IMPD Thomas Sudhop, MD 2 Scope Structure and content of an IMPD What is required for first into man trial?
Strategy Development and Strategy Execution for Technical (CMC) Development and Manufacturing from Pre-clinical to Commercial Manufacturing Technical (CMC) Development from Discovery to Pre-clinical, to IND/IMPD submission, to Early and Late Stage Clinical, to
2 Nota: La prescritta documentazione prodotta in 1 copia cartacea ( non spillata ) nonché 1 copia in formato elettronico inviata anche tramite e-mail (COMITATO.ETICO @PTVONLINE.IT) deve pervenire almeno 20 gg. prima della seduta utile.
TITLE PAGE The new Clinical Trial Regulation and corresponding new EU portal and database: an opportunity to enhance standardisation and interoperability in regulatory systems