Christine N. Bradshaw Photo

Christine N. Bradshaw

link to vcard  Counsel

973.889.4012

link to LinkedIn chrissybradshaw     

Practice

Christine Bradshaw is Counsel at Porzio, Bromberg & Newman and a member of the firm’s Life Sciences Compliance, Commercialization and Regulatory Counseling Department.  Christine is also Director, 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.

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