Post Approval Activities and Compliance: Variations Guideline 15 March, 2021 Riyadh

This course will provide an overview and analysis of the various regulatory activities that take place post-approval: In particular, the current regulatory climate will be discussed in depth and numerous examples will be provided to illustrate effective filing of notification techniques. Common issues which have caused difficulties for pharmaceutical firms will also be discussed.  The training will discuss in detail the GCC guideline for variations management and post approval commitment.