In the evolving world of pharma compliance, The PDMA Sharing Conference provides answers

Pharmaceutical CommercePharmaceutical Commerce - September/October 2012

Although much has changed since we launched The PDMA Sharing Conference 22 years ago, it’s reassuring to know that one aspect of our coming together has been constant. Each year, we have been successful in attracting outstanding pharmaceutical professionals to our annual conference, many of whom return year after year. Their involvement is characterized by their shared dedication. They ascribe to The Alliance’s main goal every day of their professional lives: a commitment to protecting the nation’s drug supply for the health and well-being of all consumers.

Perhaps there has never been a time when our industry is being so impacted by change. In this regard, our membership can be assured that at this year’s conference at the Gaylord National in National Harbor, MD, they will be updated on developments regarding the Patient Protection and Affordable Care Act (PPACA) and its ramifications for compliance professionals. General sessions will feature timely coverage, highlighted by our keynote speaker, Congressman Tom Price, MD (R-GA).

The topic of health care fraud and abuse will be examined by two legal experts: Sara Lord, a partner in the Litigation, Government Investigations and Healthcare Groups of AGG and a former Assistant US Attorney; and Roann Nichols, Assistant US Attorney and Health Care Fraud Coordinator for the District of Maryland. The topic of safe medicines will also be on our agenda, with Scott LaGanga of the Partnership for Safe Medicines headlining “The Impact of Counterfeit Medicines in our Drug Supply Chain.”

The FDA will once again be prominently featured at the conference, with Karen Rothschild, Regulatory Counsel for CDER’s Office of Compliance, Office of Drug Security, Integrity and Recalls, conducting a town hall discussion of FDA program priorities, and how they impact our business and compliance efforts. We consider ourselves very fortunate to have Ms. Rothschild’s participation in the conference, and our attendees value the insight she brings to the conference each year.

It’s clear that a great deal has happened over the years to expand our concerns. Initially, we came together to solely address the impact and challenges of compliance to The Prescription Drug Marketing Act. In 2012, our conference theme is focused on much of the federal and state legislation that has evolved. In concert with the PPACA itself, we are exploring key issues such as CIAs, sampling strategies, fraud and abuse, aggregate spend, the Sunshine Act, state laws, and reporting. Our conference agenda not only addresses these topics in General Sessions, but also provides in-depth learning opportunities through 15 distinct workshops, each led by subject matter experts from within the pharma compliance community.

This year, we are holding our conference from Wednesday through Friday, Sept. 19—21. An added benefit of this change from our typical Sunday-to-Wednesday schedule is the opportunity for attendees to extend their stay over the weekend.

As we wrestle with the challenges that confront us, we have the confidence of something that has remained constant over the last 22 years—our ability to bring together some of the best and brightest in our industry to share and learn from each other. Be sure to join us in September.


Deb Segura is Executive Director of the PDMA Alliance Inc. For more information about The 2012 PDMA Sharing Conference, please visit

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