Elektronikus gyógyszerügy Thursday, November 20, 2008
Nemzeti eCTD beadványok kezelése az Európai Unióban
Kevin Wing
eCTD Consultancy Ltd.

Az előadás angol nyelven kerül megtartásra. Proposal for a Drug Product Master File within the eCTD - eCTD national submissions are the biggest challenge for eCTDs in the EU - Typical national paper model does not support national eCTDs - Management of multiple countries within a single lifeycycle could assist - Challenges are presented within the current eCTD specification, including how to manage differing product strengths registered between countries - A Drug Product Master File approach is proposed, where strength-independent and strength-specific content are managed separately - This approach also assists lifecycle management of eCTDs submitted to a single agency, particularly when preparing line extensions for new strengths or preparing variations affecting either a subset of the range of registered strengths or affecting strength-independent content only