دورات

Understanding Pharmacovigilance System in Saudi Arabia is very important for persons working in pharmaceutical sector in the region. This course is specifically designed for persons working as Qualified Person of Pharmacovigilance (QPPV) in the regulatory affairs departments or related fields, who need knowledge of the SFDA Pharmacovigilance System and processes. This training will also enhance understanding and be beneficial to persons who work in clinical research, data management, basic research, and marketing, etc.

The Pharmaceutical Development Module should describe the knowledge that establishes that the type of dosage form selected, and the formulation proposed are suitable for the intended use. This module should include sufficient information in each part to provide an understanding of the development of the drug product and its manufacturing process. CMC is an integral part of drug development, a regulatory submission and the on-going marketing and life cycle management of a medicinal product. As drug development of the dosage form moves from concept to commercialization, the breadth and depth of CMC documentation required in submissions increases in parallel.

The Pharmaceutical Development Module should describe the knowledge that establishes that the type of dosage form selected, and the formulation proposed are suitable for the intended use. This module should include sufficient information in each part to provide an understanding of the development of the drug product and its manufacturing process. CMC is an integral part of drug development, a regulatory submission and the on-going marketing and life cycle management of a medicinal product. As drug development of the dosage form moves from concept to commercialization, the breadth and depth of CMC documentation required in submissions increases in parallel.

Understanding basics of GMP are essential skills for people working in pharmaceutical industry. This course will provide an explanation to SFDA GMP guidelines and how to prepare for inspection. This training will also enhance understanding and be beneficial to persons who work in scientific offices, regulatory affairs, pharmaceutical manufacturers, data management, basic research, project management and marketing, etc.

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.