When it Comes to Compliance, Learning Never Stops

Having the privilege to serve 
on the Alliance’s board affords me an enormous and gratifying experience, highlighted by the opportunity to participate in developing a new conference program each year. From the end of one year’s conference to the next, board members are diligent about foreseeing and planning a conference that will be timely and relevant. Because all of us are connected with the pharmaceutical, biotech and/or medical device industries, we share a clear understanding of the compliance demands that are imposed on our industry in the current, hard-pressed business and scientific environment. We recognize how essential it is to be up to the minute in understanding the challenges that our membership experiences.

The PDMA Alliance, now in its 26th year, came into being in the aftermath of the Prescription Drug Marketing Act (PDMA), which brought a heightened level of regulatory oversight to a variety of industry marketing practices—specifically, sampling to physicians. In the intervening years, our annual Sharing Conference has brought education and operational guidance to these marketing practices, as well as the continually evolving new industry guidelines.

Over the past several months, the Alliance Board has been evaluating both existing and new compliance issues of concern to our members. Among the important topics that we will be revisiting are:

• Business and compliance risk assessment
• Corporate investigations and security
• Regulatory affairs
• Quality assurance
• Auditing and monitoring
• Legal perspectives
• Sample accountability
• Ethics and compliance
• Transparency
• Compliance training
• Patient assistance
• Analytics
• Off-label marketing
• Data integrity and analysis
• Direct-to-patient (DTP) programs

We also agreed that opportunities for expanded learning are plentiful in areas such as fulfillment and logistics, digital marketing, allocation analysis, sales force automation, customer relations, supply chain management, field technology, commercial operations, promotions, sales support, and operations.

The board shared their awareness of the concerns of worldwide consumers and businesses alike, particularly anxieties related to healthcare. The cost of healthcare and the economic impact of new and existing diseases and epidemics are among the issues that have led to uncertainty and frustration. The professionals who are addressing these fears, those directly or indirectly involved in cost management, drug discovery and development are under scrutiny, questioned and criticized in unprecedented ways. Good business practices related to pricing, reliability and ethics are being challenged. Doubts about the credibility of pharmaceutical, biotech and medical device companies are driving the potential for new legislation and more regulations, possibly more stringent than ever before. The impact on compliance 
is obvious.

The overriding mission of every annual Sharing Conference prevails. We see the conference as an educational event—providing knowledge and information to people in various positions related to compliance, helping them to understand the impact that recent and anticipated legislation and regulations has on their daily responsibilities. We are committed to examining the laws and their ramifications through the sharing of attendees’ individual business experience—both successes and setbacks. And we support this sharing with the knowledgeable input of subject matter experts, as well as with the counsel of enforcement professionals. It’s clear there is no compromise when it comes to hearing from the wide range of sources who are specialists in their respective areas.

In planning the 2016 Sharing Conference, the board agreed that looking at compliance from the perspective of continual learning would be the focus of our conference theme. We decided to broaden the methodology and depth of the compliance learning experience. We built a conference program that would address new legislation and enforcement areas while continuing to deliver valuable insights into existing regulations that have been enforced for many years in the past.

We also knew that we must remain both relevant and valuable to the diverse group of individuals who comprise the Alliance. The very nature of their individual responsibilities leads to different interests; their corporate cultures and therapeutic focus areas often drive their learning preferences. We recognize that knowledge essential to compliance must consider regulations beyond the guidelines of the PDMA, Physician Payments Sunshine Act and the HHS Office of Inspector General. We reminded ourselves of the compliance learning continuum: how we must frequently return to many of the same subjects, uncovering deeper layers of understanding year after year. Because it is clear that learning is an ongoing endeavor, we summed it up briefly and succinctly. For professionals in the compliance world, Learning Never Stops.

2016 Sharing Conference attendees will experience more content than what they have encountered in previous years. Our agenda will feature two general sessions keynoted by representatives of government regulatory agencies, twenty-two workshop sessions presented by industry experts, and eight speed sessions. The latter are new learning events featuring 15-minute dives into subjects not covered elsewhere during the conference, but identified as important 
to the current or future responsibilities of our audience.

Though we will be delivering more valuable content than ever before, our timeline has been condensed. The conference will be conducted over two and a half days beginning midday Monday, and will not be held over a weekend. This change in schedule was enacted in response to our attendees’ wishes, as a good number of last year’s attendees requested that we avoid beginning the conference on 
a Sunday.

Every year, we work hard to identify and invite the experts who will bring insights to attendees that are not forthcoming from other sources. This year, we will again hear from the Centers for Medicare and Medicaid Services. We anticipate that they will give us further insights into Open Payments and the processes that are in place to support the program. We will also be hearing directly from members of the FDA, OIG and other government agencies.

Our speakers will elaborate on the implications of a wide range of compliance regulations. While some of these topics have previously been part of our agenda, they are being revisited with good reason: experience has shown that as soon as we have addressed the intricacies of a specific compliance issue, another aspect of the ramifications surfaces. It sometimes seems that the answer to every question drives us to yet another line of inquiry. And still more concerns develop over the course of each conference, which is one reason why our Sharing Forums—which are wide open, two-way dialogue on any compliance issue—are always among our most popular sessions.

Our annual 2016 Sharing Conference is recognized as the place where compliance professionals can get the answers they are looking for through sharing. The shared expertise of the experts; the shared innovations and solutions from our vendor partners; and significantly, the experiences that our pharma, biotech and medical device attendees share with each other. Without a doubt, these are the incomparable benefits that are exclusively offered by the Alliance year after year, soon to be our 26th year of sharing.

Conference registration is now open. Please go to www.pdmaalliance.org for more information.

2016 PDMA SHARING CONFERENCE EXHIBITORS

CCG Marketing Solutions

West Caldwell, NJ www.corpcomm.com

Paratus Health Systems

Alpharetta, GA www.paratushealth.com

BexR Logistix, LLC

Boerne, TX www.bexr.com/logistics

Priority Solutions International

Swedesboro, NJ www.prioritysolutions.com

BuzzeoPDMA, IMS Health

Stamford, CT www.imshealth.com

QPharma, Inc.

Morristown, NJ www.qpharmacorp.com

DF Young

Berwyn, PA www.dfyoung.com

RGIS, LLC

Auburn Hills, MI www.rgis.com

GCS Field Research

Fort Mill, SC www.gcsresearch.com

RxS LLC

Manalapan, NJ www.rxsinfo.com

G&M Health, LLC

Bridgewater, NJ www.gmhllc.com

Synergistix

Sunrise, FL www.syncrm.com

Genesis Logistics

Dayton, NJ www.genesislogistics.com

Triplefin

Cincinnati, OH www.triplefin.com

Howell Marketing Services

Elmira, NY www.howellmarketingservices.com

Uncle Bob’s Self Storage Corporate Alliance

Buffalo, NY www.unclebobs.com

J. Knipper and Company, Inc.

Lakewood, NJ www.knipper.com

Veeva Systems

Pleasanton, CA www.veeva.com

MedPro Systems LLC

Mt. Arlington, NJ www.medprosystems.com

ABOUT THE AUTHOR

Deb Segura is the executive director of The PDMA Alliance Inc., the not-for-profit organization behind the 2016 Sharing Conference, now in its 26th year.

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