Certificate in Pharmaceutical and Medical Device Law and Compliance

Students will learn to:

• Interpret relevant statutes, case law, and regulations pertaining to biotechnology
• Assess incentives for innovation, such as federal funding, licensing, and patents
• Evaluate ethical considerations related to biotechnology and the mechanisms that exist for addressing them
• Identify legal and policy issues resulting from “dual use” research

Students will learn to:

• Identify the laws, regulations, and standards to which clinical research sponsors are expected to comply, both in the United States and globally
• Evaluate factual scenarios to identify compliance risks and develop strategies for responding to them
• Assess the strengths and weaknesses of proposals to expand, reduce, or modify research sponsors’ compliance obligations

Students will learn to:

• Navigate the maze of regulatory requirements applicable to clinical research with human participants
• Evaluate proposed research projects to determine whether they meet the criteria for institutional review board (IRB) approval
• Analyze proposed regulatory changes and assess their potential impact on researchers, research subjects, institutions, and sponsors

Students will learn to:

• Identify key sources of law applicable to drug and device advertising and promotion and explain what companies must do to comply with these requirements
• Distinguish between off-label promotion and scientific and educational exchanges
• Recognize the impact of transparency and disclosure requirements on companies’ relationships with healthcare providers
• Develop strategies for avoiding government enforcement action by designing policies and practices that reflect legal requirements
• Assess the industry’s approach to self-regulation and discuss the opportunities and risks of using social media platforms for advertising, promotion, and patient relations

Students will learn to:

• Identify the primary legal, regulatory, and ethical standards with which pharmaceutical and medical device companies must comply
• Articulate best practices in corporate compliance in the life sciences industry
• Assess the risks of various business strategies and transactions from a fraud and abuse perspective

Students will learn to:

• Identify key sources of law applicable to the Internet as a decentered, community-standards focused network system
• Assess risks to cybersecurity from mismanagement, crime, terrorism, and war
• Evaluate proposed changes in the law related to cybersecurity and assess their implications for the industry and civil society

Students will learn to:

• Apply the European Union's General Data Protection Regulation (GDPR) to different business practices and technologies
• Incorporate key principles of European human rights law into an analysis of data protection practices and policies
• Anticipate future directions in the evolution of European data protection and information privacy law

Students will learn to:

• Recognize the differences between the FDA’s approach to pre-market authorization of drugs, biologics, and devices
• Evaluate how the FDA enforces its regulatory requirements and the implications of enforcement mechanisms for individuals and companies
• Explain when state tort claims against drug and device manufacturers are preempted by federal law and when they are not

Students will learn to:

• Identify red flags in business activities that would require further assessment for compliance with anti-corruption laws
• Analyze company activities to determine whether they violate the U.S Foreign Corrupt Practices Act, the UK Bribery Act, or other laws
• Articulate the key elements of a global anti-corruption compliance program

Students will learn to:

• Evaluate and determine whether a given authorization, privacy policy or business associate agreement complies with HIPAA
• Identify and articulate the potential enforcement methods and outcomes and the requirements for breach notification
• Assess and critique the regulatory choices made under HIPAA