'Quality overall summary' diaporamas de présentation

Regulatory Requirement on Dossier of Medicinal Products WHO Workshop, October 2007

759 views • 29 slides

Regulatory Requirement on Dossier of Medicinal Products WHO Workshop, October 2007

805 views • 29 slides

8th Annual Electronic Submissions Conference

Efficient Preparation of eCTD Documents for Chemistry, Manufacturing, and Controls. 8th Annual Electronic Submissions Conference. Michelle Herrera Foster, Ph.D. Principal, Sr. Regulatory Affairs Consultant CTD Quality Consulting. Disclaimer.

1.29k views • 25 slides

eCTD Specification

eCTD Specification. 17 July 2014. ACTD. ASEAN established the ASEAN Common Technical Document (ACTD) to create harmonized requirements and a common format for all submissions of dossiers in the ASEAN countries.

1k views • 21 slides

Preparing the Quality Overall Summary in the New Paradigm

Preparing the Quality Overall Summary in the New Paradigm. Michelle Herrera Foster, Ph.D. Regulatory Affairs Consultant CTD Quality Consulting. Topics. What is a Quality Overall Summary (QOS) Regulatory Evolution The New CMC Paradigm QOS as a Key Reviewer Tool QOS Pitfalls QOS Keys

548 views • 18 slides

The WHO Prequalification of Medicines Programme Dossier Assessment

344 views • 11 slides