Principles of labeling and Summary of Product Characteristics (SmPC)

Eu2P Short Course: Principles of labeling and Summary of Product Characteristics (SmPC)

OBJECTIVES

The objective of this course is to provide you with an overview of the safety communication processes and the safety risk management approach, including the safety label change process.

You will also

Develop an awareness of safety data and its influence and impact on product labelling
Develop knowledge and understanding of the practical implications of European regulations and guidance concerning labelling
Understand the principles determining the content of the Investigator Brochure (IB) and Summary of Product Characteristics (SmPC)
Become familiar with analysis and management of an emerging risk by amendments to product labelling

Labelling, safety label, Investigator Brochure, Summary of Product Characteristics, Safety risk management, Safety communication processes, CCDS, SmPC, PL(PIL)

LEARNING OUTCOMES

At the end of this course,

You will gain understanding of the scope and responsibilities of decision boards involved in managing drug safety and will understand why protecting patient safety also helps protect the pharmaceutical industry.

Besides, you will have knowledge and understanding of CCDS, SmPC, PL(PIL) and the labelling process for investigational drugs undergoing clinical trials.