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Ethics--Essential Tools for Regulatory Professionals [4.0 RAC]

4.0 RAC Credits List Price: $640 Member: $465
Ethics--Essential Tools for Regulatory Professionals [4.0 RAC]
Making the right decision isn’t always easy. Consumers today expect and demand integrity, honesty and transparency . Learn the importance of doing the right thing when product quality is at risk, from history to actual cases that effected consumer safety and trust, so you’re better prepared to deal with issues or situations that don’t always involve easy answers or clear decisions.

Laws and regulations cannot endure unless they are based on ethical codes. Ethics as a discipline is multifaceted and involves critical thinking built on well-founded principles. Operating in an ethical manner will allow you and your organization to respond quickly to problems, lower potential personal and organizational liability and conduct business in a fair manner.
This course identifies and analyzes ethical issues regulatory professionals may encounter and provides a general introduction to complex concepts, principles and theories, including bioethics and legal principles. It highlights ethical issues in areas of product development, compliance and clinical testing. This course is intended to be a companion piece to the RAPS Code of Ethics, as well as your own institution’s policies, procedures and training programs.

At a Glance
  • Target Audience: This course is intended for regulatory professionals and support staff, medical personnel (physicians, nurses), clinical investigators, research personnel, quality systems (compliance) managers, legal professionals, statisticians and corporate management.
  • Learning Level: Basic, Intermediate
  • Total Length of Course: 4 Hours
  • RAC Points: 4

Learning Objectives

Upon completion of this course, participants should be able to:
  • Cite historical events that influenced current ethical guidelines and federal regulations.
  • Identify and explain the eight core values central to the RAPS Code of Ethics.
  • Outline the necessary elements for obtaining valid and meaningful informed consent.
  • Discuss institutional review boards (IRBs), their membership requirements and scope, how they are regulated, and the protections they ensure.
  • Review ethical and scientific considerations for clinical study designs.
  • Discuss responsibilities of clinical study sponsors and investigators.
  • Define compliance and describe why it is critical for individuals and corporations.
  • Identify common compliance and ethical issues in the marketplace, including concerns and special considerations for publicly traded companies.

Lesson Titles
  • The Development of Fundamental Ethical Principles
  • Lesson 2: Fundamental Ethical Principles
  • Lesson 3: Ethics—Human Clinical Research
  • Lesson 4: Industry Compliance—Focus on Product Types
  • Lesson 5: Educational Activities

Learning Activity
This scenario-based activity lets you practice your regulatory decision-making in a safe and interesting way. Follow the events of a hypothetical story, gain important background information and hear stakeholder opinions before having to make choices about various regulatory issues. Then, see how those choices impact the story, company, product and characters. Complete this activity multiple times and see how things can change when you vary even one of your choices.

Enrollment Period: 12 months
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