Safety Information and the Product Life Cycle

PrimeVigilance, in collaboration with Pharmafocus, presents an insightful webinar featuring Dr. Cvijeta Bielen, Medical Director at PrimeVigilance, on the topic of “Company Core Labeling: Safety Information and the Product Life Cycle.”

This session explores the essential elements of company core labeling and the role of safety information throughout the product life cycle. Dr. Bielen will provide an overview of the regulatory requirements for core labeling, define key terminology related to reference safety information in both clinical and post-marketing settings, and clarify the documents applicable for these purposes.

Attendees will gain a clear understanding of how reference safety information functions during clinical development and post-approval, as well as insights into the relationship between reference safety information and product labeling. Dr. Bielen will also address common challenges in preparing these documents and share practical strategies for streamlining the process to meet regulatory standards effectively.

Key Takeaways Include:

• Comprehensive outline of company core labeling requirements and reference safety information
• Explanation of terminology related to reference safety information in clinical and post-marketing phases
• Insights into the function of reference safety information throughout the product’s life cycle
• Best practices for aligning reference safety with product information labeling
• Practical guidance on overcoming challenges in document preparation, as highlighted in recent expert group publications