Note: All training programs require physical presence and will be held in Riyadh at Bawazir Pharma Center
| FEES | SAUDI RIYAL |
| REGISTRATION FEES | SAR 2000.00 |
EARLY BIRDS REGISTRATION FEE
PAY YOUR FEE BEFORE 21 October 2022. |
SAR 1000.00 |
OVERVIEW
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.
Download Brochure Post Approval Activities and Compliance_Variations Guideline 8_November_2022
LEARNING OBJECTIVES
- Describe the role of regulatory affairs on meeting SFDA regulations
- Understand the regulatory activities that take place post approval of their products.
- Discuss the post approval commitment that must be met.
- Understand the post approval commitment and how to help company comply with them
KEY TOPICS
- Post-approval commitments
- PV
- PSUR
- RMMs
- Variations management
WHO WILL ATTEND
Professionals working in:
- Regulatory Affair staff
- Scientific office staff
- Production manager
- QA Manger
- QC Manager