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 pdmaalliance.org.
Our lineup of topics covers these concerns in full. Pre-Conference Sunday workshops will include CMS Open Payments 101, 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, PDMA 101, 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 Off-Label Marketing Workshop 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—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.
50 Shades of Regulatory Gray 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. DQSA & DSCSA, One Year Later 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—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 Data: It’s All About Integrity. 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. Investigations, Actions and Reactions 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 The Deep Dive for Data Intelligence 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.”
Educational courses include PDMA 201: The Next Generation, a follow up to last year’s 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.
This year, sessions will focus on The FDA Perspective 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 Special Town Hall 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 email@example.com.