Christine N. Bradshaw

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Christine Bradshaw is a principal at Porzio, Bromberg & Newman and a member 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.

Prior Relevant Experience
  • Honorable Gail L. Menyuk, New Jersey Tax Court, Trenton, New Jersey, Judicial Clerk, 2006-2007
  • McCarron & Diess, Washington, D.C., Law Clerk, May 2005-May 2006
Opinions, Decisions and Cases
  • Ridgewood Commons Group, LLC v. Director, Div. of Taxation, 2009 N.J. Tax LEXIS 22 (Tax Ct. Aug. 24, 2009)
Honors and Awards
  • Recognized on the New Jersey Super Lawyers "Rising Stars" List, Health Care, 2014 - 2016
  • Winner, Morris County Bar Association, Young Lawyers Mock Trial Competition, 2008

Honors and Awards

Organizations/Memberships
  • New Jersey Women Lawyers Association
Publications
  • "Getting the Deal Through - Life Sciences 2014," United States Chapter, published by Getting the Deal Through, 2014.
  • "The Federal Sunshine Act: A Practice Guide," Journal of Health & Life Sciences Law, October 2013.
  • "Getting the Deal Through - Life Sciences 2013," United States Chapter, published by Getting the Deal Through, 2013.
  • Quoted in "The Sunshine Act Is Finally Final," Forbes.com, February 11, 2013.
  • "Understanding the Sunshine Act: Dispersing the Clouds of Confusion," Porzio, March 2012.
  • "Getting the Deal Through - Life Sciences 2012," United States Chapter, published by Getting the Deal Through, February 2012.
  • "CMS Publishes Draft Regulations to Implement the Sunshine Act," Porzio Compliance Alert, December 19, 2011.
  • Editor, "The New Reality of Sales Force Behavior and Management," FDLI Monograph Series, Vol. 2, Num 6, June 2011.
  • "Taking Stock of Restrictions and Prohibitions of Academic Medical Centers," FDLI Update, May/June 2010.
  • "What's All the Commotion Over Aggregate Spend?," Thought Leadership Sales and Marketing Compliance, Fall 2009.
  • "Sales Rep Nightmares: Emerging Issues in Marketing Compliance," FDLI Update, May/June 2009.
  • "A Revised Tangible Employment Action Analysis: Just What IS an Undesirable Reassignment?" American University Journal of Gender, Social Policy & the Law, Volume 14, Number 2, Winter 2006.
Speaking Engagements
  • Panelist, , "Global Transparency Data Analytics: What They Mean for Your Company," PCF International Pharmaceutical Compliance Congress, Lisbon, Portugal, May 16, 2017.
  • Moderator, "Tap Transparency Data for Valuable Insights," CBI's 14th Annual Pharmaceutical Compliance Congress, Washington, DC, April 27, 2017.
  • Moderator, "The Evolution of Company Compliance Programs With An Eye Towards Monitoring," Porzio Compliance Forum, Newark, NJ, February 10, 2017.
  • "Optimize Global Transparency Reporting and HCP Relationship Management Strategies," CBI's 7th Annual West Coast Compliance Congress, San Francisco, CA, November 10, 2016.
  • "Transparency Disclosure Guidelines Around the World," CBI's 10th Annual Forum on Transparency and Aggregate Spend, Washington, DC, August 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, May 18, 2016.
  • "The Latest Transparency Disclose Guidelines Around the World," CBI's 6th Global Transparency Reporting Congress, Frankfurt, Germany, April 7, 2016.
  • "Transparency Going Global: How Reporting in the US Matches Up to the O-US Reporting Regime," Porzio Life Sciences, LLC Webinar, March 3, 2016.
  • "European Transparency: Lessons Learned from the American Experience," Porzio Compliance Forum, Newark, NJ, December 3, 2015.
  • "HCP Relationship Management Post-Reporting - Lessons Learned from U.S. Sunshine Act," CBI 2nd Global Compliance Congress for Life Sciences, Munich, Germany, November 18, 2015.
  • Moderator, "Industry Benchmarking Round Table - Discussing the Lessons Learned from the First Reporting Cycles; Analyzing Reporting Gray Areas; And Planning for 2016," ACI's 7th Annual Forum on Sunshine Act Compliance & Aggregate Spend Reporting, Chicago, IL, June 8, 2015.
  • "Interpreting Lessons Learned from U.S. Open Payments Reporting (Sunshine Law) into Actionable Strategies for Managing HCP Relationships and Consent Agreements,"  CBI's 5th Annual Global Transparency Reporting Congress, London, UK, April 15, 2015.
  • "Introduction to Sunshine Act," Investigational Products Track, 2014 ISPE Annual Meeting, Las Vegas, NV, October 13, 2014.
  • Co-Moderator,  "Mini Summit V: Advanced Issues In Global Transparency,  Disclosure and Aggregate Spend Compliance," The International  Pharmaceutical Compliance Congress and Best Practices Forum, Dubai, United Arab Emirates, May 6, 2014.
  • "Spotlight on Sunshine — Discussion around Sunshine Interpretations and Reconciliation," CBI's West Coast Medical Education and Research Grants, San Francisco, CA, April 30, 2014.
  • "The Devil is in the Details: Best Practices for Research Reporting and Pre-clinical Related Payments," ACI's 14th Annual Reducing Legal Risks in the Sale and Marketing of Medical Devices Conference, Chicago, IL, April 9-11, 2014.
  • "A Tour of Various National Reporting Mandates," CBI Global Transparency Reporting Congress, London, UK, April 8, 2014.
  • Co-Moderator, "Sunshine Act Compliance Boot Camp," ACI Compliance Forum, Philadelphia, PA, March 18, 2014.
  • "All Eyes on America – The Repercussions of the Sunshine Act Around the Globe," Practical Law, London, UK, March 5, 2014.
  • "Marketing Prescription Products In the Age of Obama," DIA Marketing Pharmaceuticals, Washington, DC, February 27, 2014.
  • Effective Oversight and Regulation, Managing the Sunshine Act, CenterWatch Inaugural Forum on Optimizing Clinical Research Performance, Las Vegas, NV, October 18, 2013.
  • "Taking Control of the Data: Best Practices for Auditing, Certifying with Confidence, and Enhancing Existing Compliance Procedures," panel moderator, ACI’s 5th Annual Forum on Sunshine Act Compliance & Aggregate Spend Reporting, New York City, October 8, 2013.
  • CBI's 7th Annual East Coast Forum on Sunshine and Aggregate Spend, Aggregate Spend, workshop co-leader, Washington DC, August 19, 2013.
  • "Intro Class – A Crash Course in State, Federal and Global Transparency Requirements and Integrating an Aggregate Spend Solution," Workshop co-leader, CBI's 4th Annual West Coast Forum on Sunshine and Aggregate Spend, San Diego, CA, April 23, 2013.
  • "The Sunshine Act," Webinar, Lawline.com, March 13, 2013.
  • "Best Practices for Effectively Maintaining an Aggregate Spend Program," CBI’s 3rd Annual West Coast Forum on Sunshine, State Laws and Aggregate Spend, San Diego, CA, April 16, 2012.
  • "Case Study: Purdue Aggregate Spend Approach and Solution," The 4th National Disclosure Summit on Disclosure, Transparency and Aggregate Spend for Drug, Device and Biotech Companies, Washington, DC, March 28, 2012.
  • Webinar Panelist, "The Sunshine Act: Comments from the Industry and What They Mean to You", March 14, 2012.
  • "Pharmaceutical and Medical Meeting Compliance Update: The Critical What and When's," 3rd Annual Symposium on Pharmaceutical & Medical Meeting Planning, Philadelphia, PA, September 12, 2011.
  • "State Laws, Sunshine and Aggregate Spend Boot Camp – Practical Strategies and Best Practices for Compliant State and Federal Reporting Workshop," CBI’s 5th Annual Forum on Tracking State Laws and Aggregate Spend, Arlington, VA, August 15, 2011.
  • "Aggregate Spend Forum: Solving the Aggregate Spend Puzzle," Moderator of a Panel Discussion with Inhouse Experts, Porzio Compliance Forum, Newark, NJ, October 15, 2010.
  • "Physician Payment Sunshine Provision: It's Here. Are You Prepared?" Porzio Pharmaceutical Services Webinar, April 1, 2010.
  • "Marketing Restrictions at Medical Facilities," Porzio Pharmaceutical Services Webinar, February 25, 2010.

Practice

Industries

Related Media

Bar Admissions

  • New Jersey, 2006
  • Pennsylvania, 2006

Education

American University, Washington College of Law,
Washington, D.C., J.D., cum laude, 2006

  • Publications Editor for the American University Journal of Gender, Social Policy & the Law
  • Federal Tax Clinic, Student Attorney

Duke University, Durham, North Carolina, B.A., Environmental Sciences and Policy, minors in French and Economics, 2002

  • Research Associate, Children's Environmental Health Initiative

Contact Address

100 Southgate Parkway

Morristown, NJ 07962-1997

Phone: 973.538.4006

Fax: 973.538.5146

  • Bradshaw, Christine