Pharma / Biotech
This course will provide participants with an appreciation of the key quality considerations for EU regulatory dossier submissions for marketing approval, with an emphasis on elements where specific European requirements additional to ICH guidelines must be factored into the Common Technical Document (CTD). EU guidelines impacting drug substance and starting materials, as well as the use of the CEP (Certificate of Suitability) and ASMF (Active Substance Master file) filing routes will be covered, along with quality requirements applicable to specific types of drug product filing.
Challenges presented to the global dossier by key differences between EU and US regional quality/CMC requirements in the CTD, as well as through EU product information and labelling requirements will be analysed in detail. Other specific types of regulatory interactions involving quality submissions (e.g. method of sale ‘switching’, batch specific requests, QP Declarations) will be discussed also.
An experienced ex-European regulator will deliver this course, which will be of value to personnel in the pharmaceutical and generic drug industries, both to those involved directly in preparing the quality/chemistry, manufacturing and controls (CMC) sections of the marketing authorisation application, as well as those who need an awareness of broader EU quality requirements to ensure these are addressed at all stages of the drug development process.
The course will benefit in particular those engaged in the following disciplines:
Note that the course covers the requirements for synthetic small molecules and does not address biologic
EU Framework for Quality standards and Harmonization initiatives
EU Quality submission Requirements impacting Drug Substance
Excipients in European Quality Submissions
EU Quality requirements impacting Drug Product (3.2.P) filings
EU Module 1 CTD Regional requirements
EU switch in Classification for supply of medicines
Common Application deficiencies
This session will review the most common application deficiencies identified during assessment of quality submissions, from an ex-regulator's perspective as well as from published data, with a view to helping reduce the number of CMC deficiency queries received.
At the end of the two-day course attendees will:
"I found the course to be informative, stimulating, and very timely for increasing understanding of the current Quality Requirements., The instructor was very interactive and made the course content valuable and practical for immediate application to current regulatory activities. I highly recommend this course to anyone needing a background on the subject from a true subject-matter expert." Elaine A. , Program Manager, The Evanston Group
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*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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