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.

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