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    Health (Pharmaceuticals - Compliance)

 

  • Compliance with applicable state, Federal and international pharmaceutical fraud & abuse and regulatory guidelines, laws, statutes, regulations and rules.

 

  • Developed and implemented corporate compliance policies, protocols and programs relating to life sciences, managed care, medical devices, pharmaceuticals, pharmacy organizations and pharmacy benefit management (PBM) enterprises.

 

  • Conducted internal investigations and compliance audits.

 

  • Compliance with the Clinger-Cohen Act, False Claims Act (FCA), Foreign Corrupt Practices Act (FCPA), National Institutes of Health (NIH) requirements, Federal Acquisition Reform Act (FARA), Truth in Negotiations Act (TINA).

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  • Compliance with the Child Safety Protection Act (CSPA) for child-resistant packaging, enforced by the Consumer Product Safety Commission (CPSC). 

 

  • Compliance with the New York State Drug Take Back Act requiring pharmacies both in New York State and from other states (which sell drugs within New York) to participate in some form of drug take-back program for unused drugs (which may include the use of drop boxes, mail-back envelopes, or other return methods approved by the New York State Department of Health, or the pharmacies may enter into agreements with existing drug take-back organizations), at no cost to the consumer.

 

  • Compliance with European Union (EU) directives and regulatory matters concerning life sciences, medical devices and pharmaceutical products, relating to advertising, competition, export controls, import controls, labeling, licensing, manufacturing, pharmacovigilance guidelines, product development, and research.

 

  • Compliance with the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code of Practice.

 

  • Familiarity with guidelines from the Asia-Pacific Economic Cooperation forum, Organization for Economic Cooperation and Development (OECD), World Health Organization (WHO) and World Trade Organization (WTO).

 

  • Familiarity with proceedings of cross-border agencies, such as Health Canada and the Mexican Secretaría de Salud (Secretariat of Health). 

 

  • Compliance with FDA dietary supplement health claim guidelines, device and drug approvals and recall guidelines.

 

  • Typical compliance issues for dietary supplement manufacturers such as corrective actions, complaints against and from competitors, draft notifications, enforcement risks, mandatory or voluntary submissions, petitions and regulatory compliance. 

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  • Typical compliance issues for medical device, pharmaceutical, and pharmacy manufacturers, such as advertising claims, complaints against and from competitors, corrective actions, criminal prosecutions, enforcement actions – such as by the Department of Justice (DOJ), Food and Drug Administration (FDA), Federal Trade Commission (FTC), National Advertising Division of the Better Business Bureau – FDA inspections, good clinical practice (GCP), good laboratory practice (GLP), good manufacturing practice (GMP), import detentions, injunctions, mandatory or voluntary submissions, market withdrawals, other good practice (GxP), responses to Form FDA 483 inspectional observations, product labeling, recalls, seizures, triggered disclaimers, warning letters. 

 

  • Provided training to personnel and management regarding compliance issues.

 

  • Familiarity with guidelines and recommendations from trade associations, such as the American Association of Colleges of Pharmacy (AACP), American Pharmacists Association (APhA), Food and Drug Law Institute (FDLI), International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), National Association of Boards of Pharmacy (NABP), Pharmaceutical Research and Manufacturers of America (PhRMA) marketing code.

 

  • Compliance with the Prescription Drug User Fee Act (PDUFA) and the decisions of the Office of Prescription Drug Promotion (OPDP) (responsible for reviewing prescription drug advertising materials and promotional labeling to ensure that the information contained such advertising materials and promotional labeling is not false or misleading).

 

  • Developed and implemented new compliance programs dedicated to new products specifically, including corporate policies, procedures and protocols, handbooks, sales playbooks and training materials.

 

  • Compliance with the Health and Human Services (HHS) Office of the Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers.

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  • Legl support for the design and implementation of an anti-bribery anti-corruption (ABAC) program for a global pharmaceutical enterprise.

 

  • Working knowledge of good clinical practice (GCP), good laboratory practice (GLP), good manufacturing practice (GMP), and other good practice (GxP).

 

  • Experience conducting investigations related to the marketing and sales of medical devices and pharmaceuticals.

 

  • Working knowledge of the United States Sentencing Commission (USSC) sentencing guidelines, and other governmental standards relevant to implementing effective compliance and ethics programs. 

 

  • Collaborated with relevant stakeholders throughout the enterprise during the development of corporate policies and standard operating procedures (SOPs).

 

  • Prepared compliance communications, presentations and reports for management and relevant personnel.

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  • Consultation regarding the green chemistry implications of California Proposition 65.

 

    Last updated 210509_1518

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