Webinar Description
This course will provide comprehensive knowledge of regulatory affairs practices focusing on filing requirements and detailing review processes and registration strategies.
The course will cover current Lebanese and Saudi registration guidelines for new drug application, variations, packaging and labeling…. as well as insights on regulatory best practices in these 2 countries.
The first level (beginner level) will focus on the global terminology and basic concepts in the regulatory field for both Lebanon and GCC areas. This level will also provide information on the requirements to import drugs to Lebanon and KSA in addition to the required statements for the packaging and labeling.
The intermediate level will give in depth knowledge of the content of a new drug application, variation file and renewal file in both Lebanon and KSA.
The advanced level will allow regulatory professionals to get extensive information about the critical steps of the registration dossier review along with an overview of the main registration criteria in both Lebanese and Saudi markets depending on the product category (innovator, generics, biosimilars…)
This webinar will provide comprehensive knowledge of regulatory affairs practices focusing on filing requirements and detailing review processes and registration strategies.
The webinar will cover current Lebanese registration guidelines for new drug application, variations, packaging and labeling….
as well as insights on regulatory best practices in Lebanon.
The first level (beginner level) will focus on the global terminology and basic concepts in the regulatory field for both Lebanon. This level will also provide information on the requirements to import drugs to Lebanon in addition to the required statements for the packaging and labeling.
The intermediate level will give in depth knowledge of the content of a new drug application, variation file and renewal file in Lebanon.
The advanced level will allow regulatory professionals to get extensive information about the critical steps of the registration dossier review along with an overview of the main registration criteria in
Lebanese market depending on the product category (innovator, generics,
biosimilars…)
This course will provide comprehensive knowledge of regulatory affairs practices focusing on filing requirements and detailing review processes and registration strategies.
The course will cover current Lebanese and Saudi registration guidelines for new drug application, variations, packaging and labeling…. as well as insights on regulatory best practices in these 2 countries.
The first level (beginner level) will focus on the global terminology and basic concepts in the regulatory field for both Lebanon and GCC areas. This level will also provide information on the requirements to import drugs to Lebanon and KSA in addition to the required statements for the packaging and labeling.
The intermediate level will give in depth knowledge of the content of a new drug application, variation file and renewal file in both Lebanon and KSA.
The advanced level will allow regulatory professionals to get extensive information about the critical steps of the registration dossier review along with an overview of the main registration criteria in both Lebanese and Saudi markets depending on the product category (innovator, generics, biosimilars…)
This course will provide comprehensive knowledge of regulatory affairs practices focusing on filing requirements and detailing review processes and registration strategies.
The course will cover current Lebanese and Saudi registration guidelines for new drug application, variations, packaging and labeling…. as well as insights on regulatory best practices in these 2 countries.
The first level (beginner level) will focus on the global terminology and basic concepts in the regulatory field for both Lebanon and GCC areas. This level will also provide information on the requirements to import drugs to Lebanon and KSA in addition to the required statements for the packaging and labeling.
The intermediate level will give in depth knowledge of the content of a new drug application, variation file and renewal file in both Lebanon and KSA.
The advanced level will allow regulatory professionals to get extensive information about the critical steps of the registration dossier review along with an overview of the main registration criteria in both Lebanese and Saudi markets depending on the product category (innovator, generics, biosimilars…)This course will provide comprehensive knowledge of regulatory affairs practices focusing on filing requirements and detailing review processes and registration strategies.
The course will cover current Lebanese and Saudi registration guidelines for new drug application, variations, packaging and labeling…. as well as insights on regulatory best practices in these 2 countries.
The first level (beginner level) will focus on the global terminology and basic concepts in the regulatory field for both Lebanon and GCC areas. This level will also provide information on the requirements to import drugs to Lebanon and KSA in addition to the required statements for the packaging and labeling.
The intermediate level will give in depth knowledge of the content of a new drug application, variation file and renewal file in both Lebanon and KSA.
The advanced level will allow regulatory professionals to get extensive information about the critical steps of the registration dossier review along with an overview of the main registration criteria in both Lebanese and Saudi markets depending on the product category (innovator, generics, biosimilars…)
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 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.
Who should attend?
Those having a responsibility in the following fields: Regulatory Affairs, Market Access and Compliance within pharmaceutical agents, distributors, manufacturers and scientific offices
Regulatory affairs professionals having a scientific background (pharmacists, biochemists, chemists, biologists, nurses…)
Webinar Level
Regulatory professionals whether fresh graduate, specialist / associate level and mid level manager
Duration
Number of sessions: 6
Each session will be for 2 hours including 10 - 15 min for questions and answers
Registration
If you would like to register for this webinar or you need more information, kindly fill the form by
clicking here
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Introduction to the Regulatory Concepts and Processes
Topic Cost: USD
April 12, 2014
6 - 8 pm Lebanon
3 - 5 pm GMT
Importation Process / Packaging and Labeling Requirements
Topic Cost: USD
April 26, 2014
6 - 8 pm Lebanon
3 - 5 pm GMT
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New Drug Application Content of Applications
Topic Cost: USD
May 3, 2014
6 - 8 pm Lebanon
3 - 5 pm GMT
Variations and Renewals Content of Applications
Topic Cost: USD
May 10, 2014
6 - 8 pm Lebanon
3 - 5 pm GMT
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Registration National Procedure and Timelines
Topic Cost: USD
May 24, 2014
6 - 8 pm Lebanon
3 - 5 pm GMT
Review Criteria and Registration Strategy
Topic Cost: USD
May 31, 2014
6 - 8 pm Lebanon
3 - 5 pm GMT