Keith Korenchuk counsels and advises global companies on regulatory and compliance matters worldwide, with a focus on compliance program effectiveness, compliance program implementation, operations and evaluation, and related regulatory counseling and advice.  He works in a wide variety of industries and sectors including consumer products, electronics, energy, financial services, life sciences, medical device, pharmaceutical, and technology.

Mr. Korenchuk provides regulatory and compliance guidance, advice, and solutions regarding:

  • US and global compliance systems design, implementation, and ongoing assessment
  • Compliance program evaluation under the US Sentencing Guidelines, the UK Bribery Act adequate procedures guidance, the OECD Guidelines on Internal Controls, and related national and international compliance standards
  • Specific compliance program activities including codes of conduct, training program design and delivery, monitoring, and corrective action responses
  • Global anti-bribery legislation, including the US Foreign Corrupt Practices Act, the UK Bribery Act, the Organization for Economic Co-operation and Development (OECD) Anti-bribery Convention, and related national implementing legislation
  • Internal financial controls design, implementation and remediation to institute effective oversight of key risk areas
  • Internal and government initiated investigations
  • Enterprise-wide risk management systems and programs
  • Global, regional, and country specific codes of practice and conduct, including industry codes of conduct issued by industry associations

His work spans many business functions, including research and development, global marketing, sales and marketing, strategic alliances/acquisitions, government affairs, and procurement.

Since 2001, Mr. Korenchuk has been included in The Best Lawyers in America. He has developed, led, and implemented "hands-on" educational and healthcare programs that provide pharmaceuticals and healthcare services, teachers, school supplies, library resources, and computers to indigenous communities in South America for the past 12 years.

Prior Business Experience

Mr. Korenchuk's prior experience includes serving as the CEO of a company that focused on pharmaceutical and healthcare sector compliance, as well as the CEO of a research and development company that focused on homeland security technologies.

Experience

  • Serving as an outside compliance expert under a Corporate Integrity Agreement, providing effectiveness reviews to inform Board of Director’s certifications on compliance effectiveness.
  • Assisting a global pharmaceutical company in implementing a revised worldwide compliance program, including program design and structure, code of conduct/policy revision, training, monitoring, auditing, and investigations processes.
  • Providing assistance from a compliance perspective in conjunction with government investigations involving the Foreign Corrupt Practices Act, and development and implementation of related remediation plans.
  • Providing assistance in negotiation of Corporate Integrity Agreements (CIAs) with the Office of the Inspector General (OIG) of the US Department of Health and Human Services, as well as ongoing support of CIA implementation, ongoing operation, and related OIG site visits.
  • Evaluating regulatory issues and compliance effectiveness in discrete programs and activities, including advisory boards, speaker programs, consulting relationships, investigator sponsored trials, and customer relationship databases.
  • Providing healthcare regulatory advice under the anti-kickback statute for pharmaceutical and medical device companies relating to healthcare professionals.
  • Advising on the application of state marketing and disclosure laws to the operations of pharmaceutical and medical device companies.
  • Assisting pharmaceutical and medical device companies in conducting overall program evaluations for subsidiaries in Europe, the Middle East, Latin America, and Asia, and assisting in remediation efforts.
  • Advising on compliance related issues in interactions with government officials and healthcare professionals on a worldwide basis, including consideration of issues in over 60 countries.
  • Advising the Board of Directors of a global pharmaceutical and healthcare company on compliance program effectiveness and related governance issues.
  • Evaluating the compliance infrastructure of the research and development division of a pharmaceutical company, making recommendations to enhance the compliance infrastructure, and assisting in the implementation of compliance program enhancements.
  • Assisting pharmaceutical, medical device, and health products companies evaluate and enhance their worldwide due diligence and ongoing compliance oversight of third party agents and distributors.
  • Assisting a medical device company in evaluating its US and global programs, as well as providing implementation advice and assistance.
  • Evaluating the sales and marketing function of a newly acquired business unit for a pharmaceutical company and providing post-closing remediation recommendations and assistance.

Recognition

The Best Lawyers in America for Health Care Law 2001-2016
Chambers Global: The World's Leading Lawyers for Business 2015 for Fraud & Corporate Investigations (Latin America-wide)
LMG Guide, Life Science Star 2012-2014
More

Credentials

Education
  • BA, Duke University, Phi Beta Kappa
  • MPH, Harvard University
  • JD, University of Virginia School of Law
Admissions
  • District of Columbia
Overview

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