Deb Segura, The PDMA Alliance Inc.

	Heading into the last decade of the 20th century, George H.W. Bush was in office presiding over Operation Desert Storm. The first webpage was written on the World Wide Web. Microsoft released Windows 3.0 and the 16-megabyte chip was first mass produced by IBM. The space shuttle Discovery put the Hubble telescope into orbit, revolutionizing astronomy. The first Super Nintendo entertainment system was released. The Simpsons debuted on Fox TV. And the PDMA Sharing Conference was born.

	Although originally founded as an annual three-day event, the Conference has expanded since then to include a year-round membership in the PDMA Alliance. We grew from addressing the impact of the groundbreaking Prescription Drug Marketing Act (PDMA) of 1987 to covering the myriad of additional federal and state compliance-related laws and regulations that could not have been foreseen twenty-five years ago.

	The compliance journey that led us to our landmark 25th anniversary not only expanded the subject matter we addressed; it also grew beyond the needs of pharmaceutical professionals who were directly involved in compliance to include those indirectly impacted by the ramifications of ever-increasing state and federal rules and regulations. We were dedicated to understanding the mounting compliance regulation nuances that affect scores of pharmaceutical professionals, including those in the medical device community whose Alliance membership has significantly grown in recent years.

25 topics beyond PDMA, Sunshine Act and OIG

	Our 2015 conference will take place at the Baltimore Marriott Waterfront, Sept. 27—30. Attendees will be hearing from subject matter experts, and sharing their own subject-specific knowledge and experience with their colleagues. In 2015, we are focusing on topics that Alliance members have cited as top-of-mind concerns in surveys we have conducted and from comments submitted to us at 

	Our lineup of topics covers these concerns in full. Pre-Conference Sunday workshops will include 

, a crash course for companies that have received lack of compliance notices from CMS or who are reporting Open Payments for the first time. At this workshop, we will take a hard look at CMS reporting, Open Payments transparency requirements, as well as processes and systems. Our second Pre-Conference workshop, 

, offers a history of the law and its impact on pharmaceutical and medical device companies. It is an excellent refresher course or introduction into the world of pharmaceutical compliance.

	A Fraud and Abuse topic of major interest is off-label usage. Our 

 will provide insights about training, monitoring and auditing sales. Oversight of medical teams and vendors and appropriate documentation and processes—such as Field Coaching Reports&mdash;will be discussed.

	We anticipate great interest in another topic, 

Business Ethics, From Strategy to Implementation

. This sensitive and elusive subject takes a practical approach in a discourse on the boundaries of ethical behavior. We’ll look at techniques for establishing systems that alert management when overzealousness may be crossing over to questionable actions.

 is the provocative title of a workshop that will deal with laws and requirements that may seem to have ambiguous or misleading mandates. The intentions of regulators and sound and defendable interpretations will be discussed. We will look at the rules related to the diligent management of black box products for DTP sampling, or the inclusion criteria for transparency reporting—both good examples of regulations where gray areas abound.

	A few of our workshop topics are follow-up sessions on previous issues that challenge us. 

 picks up where we left off at our 2014 Sharing Conference, studying the requirements to be met over the ten-year period until systems are completely in place. The key points of the DEA Controlled Substance Act and how it overlaps with the PDMA is a session for participants who deal with controlled substances and are subject to DEA regulations. Satisfying DEA standards when sampling controlled substances and all that needs to occur to adhere to DEA Controlled Substances is an interesting topic even for those who do not currently sample controlled substances.

	In truth, there’s a learning session covering areas of interest to meet the needs of all of our diverse attendees. 

Operational Management & Best Business Practices

 is designed to assist in day-to-day challenges—such as but not limited to&mdash;fleet, fulfillment, expense reporting, incentive compensation, sample management, SFA/CRM, data management and aggregate spend. Tactics that work for audit reviews will also be presented.

Risk Mitigation and Assessment: The Hot Points

 will consider the end-to-end processes that are essential in satisfying auditors that compliance executives are doing what they need to do. What’s needed to protect attendees and their companies will be carefully reviewed. A practitioner validation workshop, 

The HCP License Landscape — More than SLN Practitioner Validation

 session promises to be an insightful offering that presents a full picture of all the elements that come into play—such as Sunshine Act reporting, aggregate spend, data cleanliness, and off-label. To meet the challenges of auditor assessments, 

Monitoring and Auditing: Respect the Inspected

 is a workshop that can help in ensuring that risk-reducing activities are effective. The role of data integrity due to the Sunshine Act compliance and aggregate spend reporting will be reviewed in 

. This workshop will assist participants by identifying ways to prevent reporting issues before they occur. Those looking to survive an audit can gain valuable information from 

Inspection Readiness and the Art of Surviving an Audit

—a workshop designed to show how to avoid common pitfalls and help in passing any type of audit. 

 will talk about what happens when something questionable is uncovered in an investigation. From every internal and external viewpoint, insights will be shared about appropriate responses and reactions.

	A host of additional learning sessions have been organized that center around issues that can confound Alliance members. Attendees can count on a deeper understanding of Alternative Sampling and overcome the challenge to come up with electronic solutions that will fill the fraud and abuse loophole. The impact of the Sunshine Act on data intelligence is to be center stage at 

 workshop, which will point to business and compliance opportunities. We will also be looking at 

Social Media: Once it’s Out There, You Can’t Take it Back

. And experts will be on hand to lead workshops in: 

Corporate Integrity Agreements and Regulatory Enforcement Trends; State Disclosure Reporting; and Turn Outsourcing into “Rightsourcing.”

PDMA 101. Training: The Cornerstone of Compliance

 will provide an in-depth overview of the essentials of a successful training program. The conference will also feature our popular interactive session, 

Open Forum: 25 Years of Compliance Sharing

. This open forum, as well as other networking opportunities throughout the conference, gives participants the chance to look back and look ahead as they share the issues that are most pressing to them and their companies.

 and their experts will discuss what’s new at the FDA’s Center for Drug Evaluation & Research (CDER) Office of Drug Security, Integrity and Recalls. Our 

 event will include representatives of CMS, who will be discussing the ramifications of Open Payments after a full year of reporting.

25 reasons why pharma and medical device should attend

	There are many good reasons why pharma and med device industry colleagues should join us at the Baltimore Marriott Waterfront in September, but in the spirit of our milestone anniversary, I want to refer to just 25 of them. For starters, we’re not a traditional conference since our voluntary board is comprised of industry colleagues who invest their time for altruistic reasons. All that we do is built around the concept of sharing. As a not-for-profit organization, all our revenues are invested in the conference and the Alliance. Our 25-year legacy of educational excellence is distinguished by the close working relationships we maintain with the FDA, CMS and DEA. Participants always get more value for their money—three days of learning that includes meals and year-round benefits. Unfortunately, we have seen that some industry organizations have tried to mimic our original and unique approach to our conference and its agenda. They position themselves as offering conferences that closely resemble what we have successfully accomplished for 25 years. Take note, please, that they are the imitators: The Sharing Conference offered by the Alliance is the original compliance organization distinguished by the best, most up-to-the minute content that exceeds what others try to present. Significantly, the Alliance Board is comprised of industry professionals and vendor partners who are true representatives of the membership.

	As always, the Sharing Conference will feature a full exhibit hall where vendor partners present their latest products and services for the compliance industry. Exhibit hall time and learning sessions will not overlap—time is scheduled generously so that our attendees have the opportunity to experience all the conference has to offer. An entertaining and relaxed atmosphere prevails, reinforced by speakers and workshop leaders who provide information in an engaging, informal style for easy listening, learning and sharing.

	A tangible example of the distinctive value we offer is that so much is included in our conference registration fee. Once an attendee signs up for the conference and pays the fee, Alliance membership benefits are automatically granted—there’s no waiting for the conference itself to begin. Registrants have exclusive password-protected, Members-Only access to online benefits, such as online training in fraud and abuse regulation, sample accountability, and transparency.

	To sum it up, the Alliance and our annual Sharing Conference is for pharma and medical device professionals who are looking for more effective ways of carrying out their compliance responsibilities. If they want real solutions to day-to-day challenges; if they hope to enhance their career development; if they are looking to expand their network of professional contacts: they are in the right place when they attend the 2015 Sharing Conference. And this year especially, on our silver anniversary, it’s a golden opportunity to have a great time as we celebrate why the Sharing Conference is rightfully respected as the industry’s premier compliance event.

	As our agenda expands and becomes formalized, conference attendees will be learning more about additional speakers and workshop presenters via our website and email messages. For more information about the 2015 Sharing Conference and to be added to our contact list, please send an email to 

Articles

A silver anniversary with golden opportunities

2015 PDMA Sharing Conference

		What are the elements of a strong regulatory compliance program? How can we be sure that we are taking all the proper steps to mitigate risk? How are evolving state and federal regulations further complicating an already complicated task? Where can we go to better understand how to determine what we absolutely need to do, instead of what would be nice to do if we only had the time and the resources?

		These are questions that pharmaceutical and medical-device compliance professionals consider every day, and the answers are getting more and complicated. When members of the PDMA Alliance first met in a forum of learning and sharing decades ago, compliance questions, along with a strong desire to get honest and useable answers, were the common bond that united us. We shared the challenge of addressing how the newly legislated Prescription Drug Marketing Act was impacting our individual workplaces. As we developed new policies and procedures to ensure compliance, we quickly realized there was much to be gained by the ongoing sharing of our individual situations and exchanging ideas about how we might resolve a variety of issues. We knew that we needed to discover more efficient methods of handling compliance throughout our individual companies. Even then it was clear that we could find solutions by connecting with industry colleagues, by listening to each other, and by learning from each other through the open and honest sharing of our triumphs as well as our shortcomings.

		Today, those same simple acts of connecting, listening, learning and sharing are as strong an impetus as what initially brought us together 24 years ago. And at the 2014 Sharing Conference this September, we will be meeting with a similar sense of the uncertainty and trepidation due to the ongoing impact of recent legislation, a tough economy and a challenging industry.

		Those who have attended previous Sharing Conferences are aware that the focus of our annual conference has expanded and broadened. While many conference participants have been singularly and successfully dealing with the challenges of PDMA legislation over the years, we know that pharmaceutical and medical device professionals involved in compliance at all levels will continue to need an in-depth understanding of the original Prescription Drug Marketing Act and its implications.

		Instinctively we have appreciated the importance of the PDMA law and particularly its sample accountability mandates, and we know it must always be at the heart of our annual conference agenda. But we also know that there are many other considerations ahead. New state and federal legislation have taken their toll on our preparedness, and more and more regulations are on the horizon. And so, in the past several years, we have extended our educational interests to the complexities of Fraud and Abuse issues. We also saw the need to learn more about Investigations, OIG, Anti-Kickback, Off-label Promotions, Corporate Integrity Agreement (CIAs), and Sunshine and Transparency Reporting. Now, with the enactment and implementation of The Patient Protection and Affordable Care Act (PPACA), new challenges are impacting pharmaceutical and medical device companies as well. A few years ago, anticipating that the medical device segment would also be impacted by PPACA, we began to reach out to medical device compliance professionals who are increasingly interested in the learning and sharing our annual conference provides.

		In many ways, the introduction of PPACA reminds us of the same heightened compliance challenges that were prevalent at the enactment of the PDMA. So we come together at the annual conference looking for clarity, searching for how to successfully address issues such as the Physician Payments Sunshine Act, an important part of the new healthcare legislation. Now that pharmaceutical and medical device companies are required to aggregate and report hundreds of thousands of records, the implementation of these processes is staggering. Even the smallest of errors and what may seem like the most inconsequential omission can distort the data that need reporting. The required time and effort appear to be insurmountable for many compliance professionals with shrinking staff and budgets. This transparency piece of the compliance puzzle is just one of the important issues that we plan to study and discuss among the pharmaceutical and medical device professionals and vendor partners who will gather together at our 2014 Sharing Conference this fall.

		In setting the 2014 Sharing Conference agenda, the Alliance Board is planning a strategy focused on general sessions and workshops that are pertinent to today’s expanded legislation. Our guest speakers include the return of Karen Rothschild, Regulatory Counsel, FDA, Center for Drug Evaluation & Research, Office of Drug Security, Integrity & Recalls. We anticipate that Ms. Rothschild’s insights will inspire learning in many areas, including the Drug Supply Chain Security Act that is causing so much new industry buzz.

Deb Segura is the Executive Director of The PDMA Alliance

		And because the Alliance Board is unanimously convinced that effective communications are essential in this challenging business environment we share, we will also hear from a communications expert—the well-known Dave Mitchell, founder of the Leadership Difference. In addition, our Town Hall event will zero in on transparency implementation, expanding on the challenges we have witnessed over the past year and what we have learned so far. Our workshop topics have also been chosen for their relevancy to new and existing challenges, including Mock Inspections, Internal Investigations, State Reporting Requirements, Governance, Oversight and Monitoring, Data Analytics and Technology, to name just a few. A visit to our website 

 will offer a complete listing and descriptions of the workshops being offered as well as an abundance of other conference information.

		It is never far from my mind that the goal of the PDMA Alliance is educating our members to help ensure a safe and secure drug supply chain and to strengthen regulatory compliance programs. I am hopeful that all our 2014 Sharing Conference participants will be reenergized as Alliance members and fortified by their participation in the only industry conference that offers the best opportunity to Connect, Listen, and Learn with others who Share that common goal.

		For more information about the 2014 Sharing Conference and to be added to our contact list, please send an email to 

Never a better time to connect, listen, learn and share

The 2014 Sharing Conference: PDMA, Sunshine Act, OIG and Beyond

Since our first meeting 23 years ago, the annual PDMA Sharing Conference has focused on one crucial area: addressing and responding to the changing aspects of pharmaceutical compliance. With most legislative acts, the implementation of the law initiates unforeseen challenges to compliance, leading to unpredictable consequences that might be avoided through more careful scrutiny. This comes as no surprise to industries affected by legislation. We have all become accustomed to emerging nuances and subtleties of federal and state regulations as legislation goes through the process of implementation.

		When The Alliance Board came together in January to begin to develop the content for this year’s Sharing Conference, it soon became clear that the roadmap that compliance professionals are following is in the midst of great change. In the early days, our Sharing Conference was dedicated to gaining a better understanding of The Prescription Drug Marketing Act (PDMA), which required close scrutiny of sample accountability policies and procedures. Over the past few years we have experienced many more detours on the road to compliance, and we have incorporated issues such as fraud and abuse, aggregate spend, and OIG Guidance into our learning.

		Today, the landscape is even more crowded with signs of compliance that need to be addressed. Data Integrity, Corporate Integrity Agreements, the Sunshine Act, the Patient Protection and Affordable Care Act and a myriad of new and often contradictory federal and state laws are all sending compliance professionals in different directions. In planning our theme for this year’s conference, we recognized how intensely the traffic was building on the road to compliance. The signs of compliance that we need to adhere to are turning up faster than we anticipated, and as an organization of subject matter experts, The Alliance needs to provide direction for all of them.

		For Alliance members, there is an undisputed, ongoing desire to expand our perspectives, share our concerns and to learn from those who are particularly skilled at interpreting the laws. Our objective is to bring together those who can identify the implications that may elude us. Changing the way we think, changing our approach, changing old methods in favor of new ones, and changing our uncertainty to positive actions are all part of the new norm.

		The 2013 Sharing Conference, which will be held from Sept. 29th to Oct. 2nd at the Baltimore Marriott Waterfront, remains the industry’s best opportunity to gather the expertise required to address the changing signs of compliance. It is the annual meeting where attendees will find information and learning opportunities related to the most current compliance topics, presented by subject matter experts from the federal and state government, the life sciences industry and the vendor community.

		Our attendees represent professionals from pharmaceutical and medical device companies who are involved in all aspects of compliance from regulatory to sample accountability, security, sales operations, analytics, ethics, investigations, audits, sales force automation, quality assurance, risk and transparency, monitoring, and training. They come together for the unique combination of learning, sharing and networking that the Sharing Conference is known for. And with conference registration, our attendees also receive membership in The PDMA Alliance, the year-round organization that puts together this well-respected and eagerly-anticipated annual conference for life science professionals.

		This year, as in previous years, we are engaging guest speakers who know and understand the current climate of compliance, experts who keep pace with the dynamic aspects of legislation.

		We’ve had the good fortune that some of our speakers agree to return to our meeting. Specifically, I am very happy to say that we’ll hear from Karen Rothschild once again. As Regulatory Counsel of FDA’s Center for Drug Evaluation & Research, Office of Drug Security, Integrity & Recalls, Ms. Rothschild is the authority we most want to hear from regarding regulations that deal with OTC and prescription drugs, including biological therapeutics and generic drugs. Ms. Rothschild’s return is a good example of how so many aspects of compliance experience ongoing change and reinterpretations.

		I am also very pleased that our agenda features Kate Whelley McCabe, assistant attorney general, public protection division, Vermont Office of the Attorney General. Since 2009, Ms. McCabe has been Vermont’s Assistant Attorney General, where she has worked in the civil litigation and public protection divisions. Her background includes the implementation and enforcement of the state’s Prescribed Product Gift Ban and Disclosure Law, a topic of great interest to Alliance members.

		As this article went to press, we received word that a representative of the Centers for Medicare and Medicaid Services (CMS) will be taking part in our conference. Toula Bellios, acting director of the Division of Policy & External Partnership, data sharing and partnership group in the Center for Program Integrity is tentatively scheduled to be part of a general session. We are currently in the planning stages of a panel discussion on Open Payments (Section 6002 of the Affordable Care Act) featuring Ms. Bellios and others.

		The Alliance has also engaged Jeff Mackie, PhD, a well-known and highly respected humorist, to share his wit and wisdom with us. He brings his past experience as a primary motivating force in the sales and marketing team of a top pharmaceutical company, along with his gift for encouraging audiences to see themselves in a new light. We know that Dr. Mackie will challenge and inspire conference participants.

		Sharing Conference attendees who have been with us before know the high quality and value of our presenters. In the past, we have been honored by the participation of elected and appointed government officials, FDA and CDER and other regulatory counsels, attorney generals and their assistants, law enforcement professionals, investigative professionals and pharma executives with vast experience as corporate compliance officers. These experts are always willing to share their knowledge and experiences with us. They generously enlighten us with perspectives that are different from those of the average pharmaceutical executive. They provide valuable information about monitoring our compliance efforts to avoiding violations. They advise us about how to handle investigations. We have even heard from a wayward pharma sales rep who gave us a good look into how to identify behavior that circumvents compliance. In every way, what our speakers share with us influences and enhances the way we and our companies are staying compliant.

		Because we are an organization that values sharing, we consider our vendor partners to be a vital component of our organization. We include vendor representatives on our Board and we are very happy to have an outstanding vendor team in place this year: Judy Fox of Compliance Implementation Services, Jim Oppold of Triplefin, Ray Ungemach of MedPro Systems and Jeff Wojcik of TGaS Advisors. We value their insights and expertise, both in the development of our conference and in our regular communications with Alliance members. One of our objectives continues to be providing news and valuable insights on compliance issues on a year-round basis, not just during the annual Sharing Conference. The expertise of all our Board members plays a significant role in our ability to deliver these insights and I am very appreciative of their dedication to The Alliance.

		In recent years we have also benefitted from the increased participation of our conference sponsors, some of whom have signed on to offer their expertise at workshops. Their presentations bring additional educational value by contributing new learning opportunities from the vendor perspective, the people who are innovating products and services that support compliance. These valuable vendor contributors are called on to follow the same signs of compliance that highlight our 2013 Sharing Conference journey.

		The Alliance is building a legacy of transparency through an assembly of life science professionals who share the goal to protect our nation’s drug supply for the health and well-being of consumers across the land. Their honesty about the real challenges of compliance, and their successes and struggles in meeting those challenges, are all valuable lessons to be learned. We accept change as the new norm in 2013, replacing the fear of uncertainty, and paving the way for a better understanding of the challenging signs of compliance.

Customer data management services and regulatory compliance; proactive compliance support.

Comprehensive provider databases including healthcare providers (HCPs,) healthcare organizations (HCOs,) and their affiliations, coupled with the largest medical claims database in the U.S.; compliance and analytics of these databases. 

Regulatory compliance services, including PDMA, anti-kickback statutes, False Claims Act, FDA, OIG, Physician Payments Sunshine Act and state aggregate spend compliance regulations.

PDMA Alliance: Change is the new norm

	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 