Regulatory Due Diligence for Product Development

This course will provide a basic understanding of the principles and practices of due diligence within the medical product environment.

This course will provide insight to better prepare the due diligence regulatory affairs (RA) team member by providing a basic understanding of the principles and practices of due diligence within the medical product environment. It covers a wide range of issues, including the reasons for performing due diligence, types of due diligence and responsibilities of a due diligence team. The processes and checklists commonly used in due diligence are also discussed and put into practice using a hypothetical case study. You will learn how best to contribute to the goals of the due diligence team, and by extension those of the company, if you are asked to represent the regulatory perspective.

At a Glance

Target Audience: This course is intended for professionals in regulatory and related departments who will benefit from an overview of the due diligence process or those who have served on a due diligence team, by providing a broader view of industry practices.

Learning Level: Basic, Intermediate

Total Length of Course: 3 Hours

RAC Points: 3

Medical Device Certificate Elective

Pharmaceutical Certificate Elective

Enrollment Period: 12 months

Learning Objectives

Describe the due diligence process and situations in which it is commonly used

Distinguish between commercial and R&D due diligence

List the responsibilities of a due diligence team member

Use a checklist to conduct a regulatory due diligence and write assigned portions of a due diligence report

Describe onsite and virtual data rooms and list the advantages of each