Christine N. Bradshaw

Principal

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Overview

Christine Bradshaw is a principal at Porzio, Bromberg & Newman and a co-chair of the firm's Life Sciences Compliance and Regulatory Counseling Department. Christine is also Vice President, Regulatory and Compliance Services of Porzio Life Sciences, LLC, a subsidiary of the law firm.

Christine counsels pharmaceutical, medical device and biotechnology companies on issues related to state marketing disclosures and gift prohibition laws and state and federal regulation of the distribution of trade and sample product including PDMA, licensing, and pedigree issues. She has drafted numerous compliance-related corporate policies and SOPs for pharmaceutical and medical device companies, including SOPs governing interactions with healthcare practitioners, tracking and disclosing aggregate spend, reporting of thefts and losses, and performing inventories and reconciliations. Christine also has experience counseling companies on issues related to the Food, Drug and Cosmetic Act, the Anti-kickback Statute, the False Claims Act, the OIG Compliance Program Guidance for Pharmaceutical Manufacturers, the PhRMA Code on Interactions with Healthcare Professionals, the AdvaMed Code of Ethics for Interactions with Health Care Professionals, and the ACCME Standards for Commercial Support. Christine also creates and conducts management and sales force training on various compliance issues. She performs audits, gap analyses, and risk assessments in a variety of areas, including review of promotional materials, sampling activities, and aggregate spend systems.

Memberships

  • New Jersey Women Lawyers Association

Speaking Engagements

  • The Evolution of Compliant HCP Engagements and Transparency: Your Guide to the Past, Present, and Future; PCC Webcast Series - Pharmaceutical Compliance Digital Week, 5/21/2020
  • Where Does the Sun Shine Now? in Hirshhorn; PCF Mini Summit 8: Open Payments, 11/08/2018
  • Build a Strategic Approach to Risk Identification, Monitoring, and Auditing; CBI- Life Sciences Compliance Congress West, 10/18/2018
  • Roundtable Discussion: Lessons Learned and Continuing Implementation of General Data Protection Regulation (GDPR); CBI's Life Sciences Compliance Congress West, 10/17/2018
  • HCP Engagement Strategies and Contracting; CBI's 15th Annual Pharmaceutical Compliance Congress, Washington, DC, 4/24/2018
  • Off-Label Communication — Deep Dive into the New Regulatory Updates and Actions; CBI's West Coast Compliance Congress, San Francisco, CA, 10/17/2017
  • New and Evolving Requirements for Pharmaceutical Representatives: Chicago, Nevada and Others, 7/31/2017
  • "Privacy - An Overview of Life Science Company Basics from the U.S. and Global Perspective, "Global Issues, Including the Privacy Shield," Porzio, Bromberg & Newman CLE Presentation, Helsinn Therapeutics, 7/11/2017
  • Global Transparency Data Analytics: What They Mean for Your Company; PCF International Pharmaceutical Compliance Congress, Lisbon, Portugal, 5/16/2017
  • Tap Transparency Data for Valuable Insights; CBI's 14th Annual Pharmaceutical Compliance Congress, Washington, DC, 4/27/2017
  • The Evolution of Company Compliance Programs With An Eye Towards Monitoring," Porzio Compliance Forum, Newark, NJ, 2/10/2017
  • Optimize Global Transparency Reporting and HCP Relationship Management Strategies; CBI's 7th Annual West Coast Compliance Congress, San Francisco, CA, 11/10/2016
  • Transparency Disclosure Guidelines Around the World," CBI's 10th Annual Forum on Transparency and Aggregate Spend, Washington, DC, 8/16/2016
  • Tips for Moving From Domestic to International Reporting and EFPIA-U.S. Reporting Requirements; CBI's 7th Annual West Coast Forum on Transparency and Aggregate Spend, San Diego, CA, 5/18/2016
  • The Latest Transparency Disclose Guidelines Around the World; CBI's 6th Global Transparency Reporting Congress, Frankfurt, Germany, 4/07/2016
  • Transparency Going Global: How Reporting in the US Matches Up to the O-US Reporting Regime; Porzio Life Sciences, LLC Webinar, 3/03/2016