Workshop Description
This workshop will provide comprehensive knowledge of regulatory affairs practices focusing on filing requirements and detailing review processes and registration strategies.
The course will cover current Saudi registration guidelines for new drug application, variations, packaging and labeling….
as well as insights on regulatory best practices in Saudi Arabia.
The first level (beginner level) will focus on the global terminology and basic concepts in the regulatory field
for GCC areas. This level will also provide information on the requirements to import drugs to 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 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 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
Saudi market.
The intermediate level will enable the participant to prepare a registration file according to the latest guidelines and requirements in KSA; 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…)
Workshop Level
Regulatory professionals whether fresh graduate, specialist / associate level and mid level manager
Duration
3 days
Sorry for the inconvenience, but there are no data to display right now, please come back later or contact us for more details.
Sorry for the inconvenience, but there are no data to display right now, please come back later or contact us for more details.
-
Introduction to the regulatory concepts and processes – GCC
-
Importation Process / Packaging & Labeling Requirements – KSA
Sorry for the inconvenience, but there are no data to display right now, please come back later or contact us for more details.
-
New Drug Application Content of Applications – KSA
-
Variations & Renewals Content of Applications – KSA
Sorry for the inconvenience, but there are no data to display right now, please come back later or contact us for more details.
-
Registration National Procedure and Timelines – GCC centralized vs. KSA
-
Review Criteria and Registration Strategy- KSA