Regulatory Due Diligence for Product Development

This course will provide insight to better prepare the due diligence regulatory affairs 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
  • Learning Objectives
  • Lesson Titles
  • Learning Activity
  • Registration Options

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: 3–6 Hours
  • RAC Credits: 3
  • Formats: PC and Tablet (iPad and Android)
  • Cost: Member $360; List $495
  • Need more information?
    View the RAPS Online University FAQs.

Learning Objectives

Upon completion of this course, participants will be able to:

  • 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

Lesson Titles

  • Lesson 1: What Is Due Diligence?
  • Lesson 2: Developing a Due Diligence Strategy
  • Lesson 3: Core Activities
  • Lesson 4: Outcomes and Reporting

Learning Activity

Regulatory Due Diligence Learning Activity

The processes and checklists commonly used in regulatory due diligence are put into practice using two hypothetical case studies.

Registration Options

This course is available for purchase as follows: