Deb Segura, PDMA Alliance Executive Director

The enthusiasm is contagious as we approach The 2010 PDMA Sharing Conference. In addition to the high level of interest in celebrating 20 years as the premier PDMA compliance event, we are also initiating new learning opportunities centered on Fraud and Abuse issues, all related to our traditional focus on sample accountability. Expanding our outlook and our outreach is not a new phenomenon to those of us who planned October’s milestone event. Each year, The PDMA Alliance Board strives to introduce a new element to the conference. And year after year, we remain determined to increase the value for all our attendees by delivering more. 

For 2010, our primary focus on sample accountability is not about to change. Extension to the new subject area of Fraud and Abuse allows us to offer conference 

participants more: more about investigations, more about the PhRMA Code and more about Anti-Kickback, OIG, The Sunshine Act legislation and Risk Assessment issues to name a few. 

The additional learning track expansion is a natural progression. From a myriad of fraud and abuse litigation and settlements that have been in the headlines in recent years — to new state and federal regulations – to the potential impact of the healthcare reform legislation, we are now confronted with uncertainties and challenges that are entirely new to our industry.

To many of us, the implications of new laws may seem staggering. The need to listen and learn from the experts about what the future may hold in terms of adherence to the newest legislation is on our minds and is something we plan to address at The 2010 PDMA Sharing Conference. 

Sharing his viewpoint on some of the current issues our industry is facing will be Michael Levy, Esq., Director of the Division of New Drugs and Labeling Compliance, Office of Compliance of the FDA. Conference attendees will gain much from his general session presentation, FDA Perspective: Insights from the Office of Compliance. 

Our general sessions will also include a closer look at The Sunshine Act in the PhRMA Perspective: The Evolving Federal and State Compliance Environment, presented by Marjorie E. Powell, PhRMA’s Senior Assistant General Counsel. Another expert, Don Rabon, the noted fraud investigator and author, will speak about the challenges associated with detecting deception in both interpersonal communications and written documents as he poses the question, “Is That The Truth?” 

Our two learning tracks will offer a variety of PDMA Compliance and Fraud and Abuse topics that impact the pharmaceutical industry in many different but related ways. Workshops under the PDMA Compliance track will concentrate on our traditional focus of sample management, while bringing an enhanced perspective. The new Fraud and Abuse workshops will expand our learning into broader areas that directly (or indirectly) impact our jobs. The PDMA Alliance Board has spent a lot of time working with our knowledgeable workshop presenters to put together these outstanding learning and sharing sessions. We are pleased to address so many issues for the very first time at the 2010 conference while revisiting some hot topics that past attendees have indicated they want to talk more about. 

Amid all the new considerations, we remain constant in what we hope attendees will take away from their PDMA Sharing Conference experience. This year, as in the preceding 19 years, our goal is for attendees to return to their respective workplaces more knowledgeable and better prepared to be more effective at their jobs. I am optimistic that their company colleagues will find their enthusiasm contagious, recognizing the educational value that comes from our conference. And I am confident that attendees will continue to benefit from the positive response of information that is available through their year-long membership in The PDMA Alliance, the organization developed by the industry, for the industry. The fact that we continue to live up to that identity is indeed something to celebrate! PC 

Deb Segura, PDMA Alliance Executive Director

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