Module 3 2019

What is Assessment?

Assessment is a balancing act … risk vs. benefit.

• Regulators have a key responsibility to protect public health, by assuring the quality, safety & efficacy of medicinal products.

• Regulators have a responsibility not to impose unnecessary burdens on

the pharmaceutical industry, as this may delay the introduction of new medicines with unnecessary costs. Assessment is the process & outcome of a critical review of information, focusing on key aspects that could impact quality, safety & efficacy.

The Organisation for Professionals in Regulatory Affairs