OVERVIEW
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.
LEARNING OBJECTIVES
At the conclusion of this training, participants will be able to:
- Define the key principles and processes used by the Saudi Food and Drug Authority (SFDA) in regulatory submission and approval.
- Define official regulatory policies and other issues pertinent to a successful SFDA and GCC regulatory strategy
- Describe key differences between National and the Gulf Cooperation Council Drug Registration (GCC_DR) regulatory requirements.
- Describe the requirements for marketing applications for drugs and biologics, New Drug Application (NDA), Biosimilares, Generic drugs, herbal and health products and document preparation.
- Recognise SFDA oversight and processes during the post-approval phase.
- Interact appropriately with the SFDA during all phases of drug registration
- Understand the regulatory requirements for prescription drug labelling and advertising/promotion.
KEY TOPICS
- Principals of Regulatory Affairs (RA) and Legal Framework
- SFDA overview and pharmaceutical institutions licensing
- Principles of Products licensing and Evaluation
- GMP Inspection and Products Pricing
- Overview of the pharmacovigilance system
- Principles of Products Classifications and Listing
- Products Import, Release and Advertising
- Overview of the SFDA Electronic systems
WHO WILL ATTEND
Professionals working in:
- Pharma Regulatory Affairs
- Fresh Graduate
- Scientific Office Managers
- Regulatory Authorities.
- Dossier Management
- Pharmacist
- Compliance
BCG Approach
The BCG approach is grounded in the belief that compliance and quality should be managed as any other critical business issue. Proper quality management and a state of regulatory compliance will result in a decrease in direct costs such as rejects, and indirect costs such as adverse events and recalls.
The BCG offers professional services to complete all aspects of regulatory affairs. The depth of our experience and knowledge acquired from our work with the Regulatory authorities ,ICH, International Standards Organization is made available to our partners. Our team can guide your organization through compilation of an original submission, perform submission maintenance and step in to support your internal staff during workload peaks.