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PCC 2023 — Pharmaceutical Compliance Congress
Delivered as a Hybrid Event April 2023
April 25 - 27, 2023

Craig Bleifer
Partner at Akin, Gump Strauss, Hauer & Feld LLP

Profile

Craig Bleifer is an experienced health care executive, having previously served as general counsel for Novo Nordisk and for Daiichi Sankyo. He has been the leader of diverse corporate functions including Legal Affairs, Litigation, Compliance and Audit, Intellectual Property, Regulatory Affairs, Government Affairs & Public Policy, Communications and Corporate Social Responsibility.

As a practicing corporate and health care attorney for almost 30 years, he advises clients on legal, compliance, policy and regulatory matters relating to health care products and businesses along the full spectrum from discovery through commercialization.  He is well versed in the process and the inner-workings of the U.S. Food & Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS).  Craig also has years of experience with critical health care compliance issues and counsels clients on relevant Department of Justice and Office of Inspector General guidance and enforcement practices and industry codes of conduct to craft compliance charters, policies, board and executive fiduciary training, employee role-based training, the creation of effective monitoring and auditing programs, instituting a “RAMP”, and conducts internal compliance investigations.  He also advises clients on federal and state “Sunshine” spend/transfer of value reporting, and on compliance with varying local and state price transparency reporting and other compliance requirements.

A leader in the health care industry, Craig formerly served as a chair of the Pharmaceutical Research and Manufacturers of America’s (PhRMA) Law Section Executive Committee and as a chair and board member of the Healthcare Institute of New Jersey (HINJ).  He was awarded General Counsel of the Year by NJBIZ and was awarded In-House Legal Department of the Year by the New Jersey Law Journal.  Craig is regular author of articles on health care issues and speaker at industry-wide events. 

He is a graduate of the New York University School of Law and holds a B.A. from Vassar College in Sociology.

Agenda Sessions

  • Examination and Application of Key Learnings from Industry’s Most Recent CIAs

    3:30pm
  • Advertising, Promotion and Communication Strategies for Biologics, Biosimilars, and Interchangeable Biosimilars

    3:30pm