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YouR xPert is a service that allows your company to reach out to the expert, or panel of experts, you want to quickly seek regulatory advice on a complex promotional topic, or to validate a position your organization has taken. We can also benchmark across your industry peers to gain confidential, anonymized input on the topic you are vetting.
Some guidance for planning to schedule a YouR xPert advice session:
Provide materials to YouR xPert in advance of your scheduled call via upload
Be prepared to discuss the topic during the initial part of the discussion with YouR xPert
Billed time includes review of materials you may provide in advance of the call with YouR xPert as well as the time on the call with YouR xPert, and any agreed to follow-up activities you would want YouR xPert to conduct for you.
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Tracy is a respected regulatory leader with more than 20 years of experience in the pharmaceutical industry. She is the Co-founder and Managing Partner at OneSource Regulatory. Her senior regulatory management experience included her recent role as Vice President, Regulatory Affairs, Global Labeling, Advertising & Promotion, Regulatory Policy & Intelligence at AbbVie (formerly Abbott Pharmaceuticals), Senior Director, Global Regulatory Affairs at Shire Pharmaceuticals, Director, Regulatory Affairs at Wyeth, and Director, Global Regulatory Strategy at Pfizer.
Tracy is a board advisor and Regulatory Officer in Residence for Doctor Evidence, a specialty software platform and services company that transforms clinical studies, drug labeling and epidemiological databases into reusable dynamic relational databases, and a board advisor for Daylan Pharmaceuticals, a start-up company conducting ophthalmology research. Tracy is currently a steering committee member on the DIA.HBA Leadership Project which was formed by the Drug Information Association (DIA) and the Healthcare Businesswomen’s Association (HBA) to advance the careers of women in regulatory, medical, legal and compliance. She was a member of the FDLI planning committee for the 2012 Advertising & Promotion conference.
Tracy received her Juris Doctor from Washburn University School of Law, and her Bachelor of Arts from the University at Albany, State University of New York, Rockefeller College of Public Affairs & Policy.
Rob specializes in assisting pharmaceutical, biotech and medical technology companies with global risk assessments, independent reviews and ethics and compliance program development. A representative sample of his experience includes developing global compliance programs in promotional compliance, sales and marketing practices, fraud and abuse laws, state laws, sample compliance, compliance training and compliance monitoring and auditing. He has significant industry experience in the areas of healthcare compliance, regulatory affairs and risk management and past positions include Compliance Officer and Sr. Director of Regulatory Affairs.
Rob received his B.S. in Biology from Utah State University and his J.D. from The John Marshall Law School in Chicago, Illinois.