Practice

Christine Bradshaw is an associate of Porzio, Bromberg & Newman and a member of the firm’s Life Sciences Compliance, Commercialization and Regulatory Counseling Department.  Chrissy is also Manager of Regulatory and Compliance Services of Porzio Life Sciences, LLC, a susidiary 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

• Winner, Morris County Bar Association, Young Lawyers Mock Trial Competition, 2008

Organizations/Memberships

• New Jersey Women Lawyers Association

Publications

• Contributor, "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.
• Contributor, "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

• "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 In‐house 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.