Workshop Description
This workshop will provide comprehensive knowledge of regulatory affairs practices focusing on filing requirements and detailing review processes and registration strategies.
The workshop will cover current Lebanese registration guidelines for new drug application, variations, packaging and labeling, as well as insights on regulatory best practices.
Learning Objective
By completing the beginner level, the participant will get familiar with the registration framework and the essentials to secure the importation of drugs to Lebanese market.
The intermediate level will enable the participant to prepare a registration file according to the latest guidelines and requirements in both Lebanon; and this will cover all the registration steps from the initial approval passing by the post approval changes (variations) till the renewal or cancellation of the registration.
The advanced level will help regulatory professionals in better assessing the registration strategy to be adopted depending on the key parameters that are adopted for drug registration in Lebanon.
Registration
For registration fees, please email us at
[email protected]
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Introduction to the regulatory concepts and processes
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Importation Process / Packaging and Labeling Requirements
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New Drug Application Content of Applications
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Variations and Renewals Content of Applications
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Registration National Procedure and Timelines
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Review Criteria and Registration Strategy