Regulatory and Compliance

Regulatory & Compliance

Our regulatory and compliance training provides an understanding of the laws and regulations that are shaping the industry and how they are impacting today’s product/service decisions.

Ethical Dimensions of Research Decisions

This module discusses the ethical issues that underlie practical research decisions, as well as the Statements of Principle and Good Clinical Practice (GCP) documents that aim to help guide such ethical choices.

Ethical Issues Related to Drug Safety Monitoring, Pricing, and Off-Label Promotion

Life science companies have ethical responsibilities beyond compliant advertising and promotional activities. Increasingly, manufacturers are being held accountable for the safety of their products once they have entered the marketplace. In addition to reporting issues associated with their products, companies may be required by the FDA to take additional risk mitigation steps. Companies doing business with certain federal programs must comply with pricing rules, but they must also consider the broader ethical implications of the prices they charge for their products, weighing public good against the needs of the organization and future product development. Sales professionals must also be familiar with their companies' policies on the issue of off-label promotion - what they can and cannot do when a prescriber asks about using a medicine for an indication not specifically approved by regulatory authorities. This module examines regulatory and industry response to these issues.

Ethical Responsibilities when Conducting Clinical Trials

This module discusses ethical issues that are of importance during and subsequent to the conduct of a clinical trial.

Ethics in Interactions with Healthcare Professionals

This module focuses on these issues, including a discussion of promotional gifts and educational support. It also discusses industry guidelines for interactions between life science sales representatives and healthcare professionals, which aim to prevent abuse of promotional practices.

Ethics in Life Science Marketing and Advertising

This module describes the US regulations regarding marketing and advertising; the ways in which the FDA seeks to ensure that advertising is accurate, fair, and balanced; and the guidelines on consumer advertising issued by PhRMA for its members.

Impact of the HIPAA Privacy Rule

This module focuses on the Privacy Rule, which was added to the Health Insurance Portability and Accountability Act (HIPAA) of 1996. It discusses the effect HIPAA has on physician practices, including the impact it has on the technologic programs that disseminate patient information.

Key International Regulatory Bodies and Groups Associated with Ethics and Compliance

This module focuses on international groups involved in such harmonization efforts. This includes government agencies that implement regulations and monitor compliance in the European Union (EU), Japan and the US, whose governments have been most active in international efforts to harmonize life science industry regulations. We then focus on international associations that articulate ethical goals and work to translate those goals into globally accepted standards and practices.

Key US Regulatory Bodies and Groups Associated with Ethics and Compliance

This module focuses on the US-based groups involved in influencing, generating, and enforcing mandates in the life science industry, including the government agencies that implement regulations and monitor compliance. It then discusses the professional and industry associations that issue voluntary guidelines to ensure ethical behavior among their members.

Late 19th and 20th Century US Legislation

Early US legislation laid the groundwork for the establishment of the FDA and its mission?to prevent misbranding and commerce in adulterated, unsafe, or ineffective products. A process for licensing medicines began to take shape. In response to tragic events, the federal government set standards of proof of efficacy and safety that pharmaceutical manufacturers must provide before they can market their medicines in the US. New laws and older ones were used to address emerging problems, such as drug abuse and Medicare/Medicaid fraud. The first regulations regarding promotion of products became law. This module describes how these early laws helped shape the present regulatory environment in the US.

Late 20th and 21st Century US Legislation

Trends in recent US legislation have focused on increasing transparency in promotional activities of life science companies, protecting patient privacy, and finding a balance between improving patient safety and speeding access to innovative medical products. This module focuses on legislation that has been enacted at the federal level, such as the Prescription Drug Marketing Act, HIPAA, FDAAA, and the Affordable Care Act (ACA). Trends in federal legislation and state and local laws are also discussed.

Regulations Governing Life Science Marketing

This module discusses how advertising and promotional materials are regulated by the US and by international associations. Regulations and self-regulatory guidelines within the United States and abroad are then described.

Regulatory and Ethical Compliance in the Life Sciences

This module describes the sources and scope of mandates affecting the life science industry, their purpose, the risks of noncompliance to companies and individuals, and the steps pharmaceutical manufacturers take to ensure and demonstrate compliance.

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