Conducting Pharmaceutical Safety and Efficacy Reviews and Preparing Review Reports

Overview

Delivery method

Online

Duration

–

Audience

Inspectors

Description

Welcome to the Conducting Pharmaceutical Safety and Efficacy Reviews and Preparing Review Reports on Submissions for Marketing Authorization online training course

The eLearning course, Conducting Pharmaceutical Safety and Efficacy Reviews and Preparing Review Reports on Submissions for Marketing Authorization provides instructions and guidance on review activities conducted to apply governing statutes and regulations in a predictable and consistent manner. SOPs are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this course may be acceptable provided they are supported by adequate justification. This course should be experienced in conjunction with the Food and Drugs Act and Regulations, other applicable acts and regulations, and relevant sections of other applicable review SOPs and guidance documents for external stakeholders.