Learning Objectives
Upon successful completion of this course, the student will be able to describe four key ethical goals for the pharmaceutical industry – patient safety and wellbeing, patient dignity and privacy, data integrity, and transparency; identify key US regulations and international, professional, and industry codes aimed at achieving these goals; describe the impact of ethics and compliance on the pharmaceutical industry, from R&D through sales and marketing; and describe the specific impact of recent and pending legislation and codes, including the PhRMA Code on Interactions with Healthcare Professionals, on the activities of healthcare representatives.
Who Should Take This Course
Sales managers and representatives; national account managers who negotiate contracts with government agencies or large accounts; marketing managers and those engaged in creating promotional campaigns and materials or distributing company support to CME providers.
Career Application/Benefits
The obligation to behave ethically and comply with regulations applies to everyone working in the pharmaceutical industry, in every area of a company and at every level of involvement – from strategic development to tactical implementation. Some may be involved in research activities conducted under strict ethical and regulatory mandates. Others may help create and sustain an ethical environment through their supervisory responsibilities or by auditing for demonstration of compliance through quality assurance activities. Those engaged in marketing and sales are affected directly by regulations and professional codes that mandate ethical behavior in pricing, negotiating contracts, ensuring product safety, and promoting products. All are responsible for considering the ethical and legal implications of their decisions – decisions that can directly affect the organization’s resources and relations with regulatory agencies, the healthcare community, and the general public.
Chapter Content
Chapter One: Overview of Ethics and Compliance
- Regulatory and Ethical Compliance in the Pharmaceutical Industry
- Key US Regulatory Bodies and Groups Associated with Ethics and Compliance
- Key International Regulatory Bodies and Groups Associated with Ethics and Compliance
Chapter Two: Key US Regulatory Mandates
- Early US Legislation
- Recent US Regulatory Mandates
Chapter Three: Ethics and Compliance in Pharmaceutical R&D
- International Statements of Ethical Responsibilities
- Ethical Dimensions of Research Decisions
- Ethical Responsibilities When Conducting Clinical Trials
Chapter Four: Ethics and Compliance in Pharmaceutical Sales and Marketing
- Ethics in Interactions with Healthcare Professionals
- Ethics in Pharmaceutical Marketing and Advertising
- Ethical Issues Related to Drug Safety Monitoring, Pricing, and Off-Label Promotion