Four days Online training on the Documentation Format Requirements ,Principles of Assessment for the WHO Prequalification and Emergency Use Listing of Vaccines.
- Written by Chief Editor Fri, 10 Jun 22 PM
Events
All registrations of interest will be reviewed as space is limited. Only selected registrants will be sent a link for participation
This
workshop, organized by the WHO Local Production and Assistance Unit in the
Regulation and Prequalification Department, aims to enhance the understanding
of manufacturers, particularly in low- and middle-income countries, on the
quality requirements for vaccines as described in the guidelines of WHO and
other regulatory authorities for prequalification and licensing purposes.
The workshop will cover the
following topics:
• PQ/EUL-related specialized technical assistance
• The Common Technical Document (CTD) and eCTD
• Quality Assessment Principles
• Assessment of Drug Substance
• Assessment of Drug Product
• Discussion of case study
• Nonclinical & Clinical studies
Period: The training will take place from 28 June to 01 July 2022.
For more information and application, Please click here
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