Understanding drug regulatory affairs in the GCC region is  very important for persons working in pharmaceutical  sector in the region. This course is specifically designed for  persons working in the regulatory affairs departments or  related fields, who need knowledge of the SFDA and GCC  regulatory processes. This training will also enhance  understanding and be beneficial to persons who work in  clinical research, data management, basic research,  project management and marketing, etc.

The rise in costs of pharmaceutical products in general affects all sectors of the health care industry, including private insurers and patients. This workshop shall give an overview on the pricing practices of pharmaceutical products in SFDA and GCC_DR. In addition, a thorough discussion on the pricing policy by SFDA shall be presented and what you need to learn to price your products.

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.