Dettaglio Evento

ASMF: aspetti GMP e criticità regolatorie


23 novembre 2018


Via Adolfo Ferrata, 19  Pavia 


Nel corso della giornata sono stati  trattati i seguenti argomenti: 

·    Quality standards and guidances: overview related to the main Regulatory Authorities

·    Starting material and API starting material: justification for the positioning in a multi-step process 

·    Compliance to D.Lgs219/2006: use and import of API starting material

·    Traceability, supply chain and QP declaration: which impact for the drug product

·    Impurity profile and carryover of related impurities: recent approaches for identified and unidentified impurities

·    Solid state: why the increasing interest for the solid state of APIs?

·    Modern trends in quality and regulatory aspects of herbal Extracts

·    Analytical procedures and validation: how to guarantee the robustness of data and compliance with regulations

·    Stability data and attribution of retest/shelflife

·    Submission of data: ASMF or CEP?

·    Electronic submission: use of e-CTD

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