1:30pm Monday Oct. 15 thru

3:00pm Wednesday Oct. 17, 2018

MGM National Harbor

101 MGM National Ave.

Oxon Hill, MD 20745

Brought to you by the not-for-profit PDMA Alliance Inc. dba:

Workshops

Workshops will provide attendees with a focused and in-depth platform for presentations, discussion and interaction in a specific compliance subject area. Here are just some of the workshops our teams are working on for the Sharing Conference this October. Check back soon for more workshops and additional session information!

PREPARING TO SAMPLE COLD CHAIN PRODUCT

Presented by Kevin Sharp, Genentech and Brian Bauer, Priority Solutions International

 

The number of products that require strict temperature management has been steadily trending up and shows no sign of stopping. Sampling cold chain product is causing many pharmaceutical manufacturers to shift from a Direct to Representative ‘sample carry’ model to a ‘sample send’ program directly to healthcare practitioners. A Direct to Practitioner model introduces significant additional compliance checks and balances. This workshop will touch upon the unique challenges of managing cold chain sampling product where product quality and integrity are vital to the success of the program. Throughout the discussion we will highlight specific steps in the process that have a direct impact on quality and compliance. Areas of discussion will include understanding the pro’s and con’s of Sample Carry vs. Sample Send programs and reviewing best practices for maintaining product integrity during fulfillment and distribution. Presenters will also review methods for selecting the best packaging/shipper solution based on temperature and seasonal needs. This will be an interactive discussion with plenty of time for Q&A throughout the presentation.

THE HUMAN ELEMENT OF SYSTEM INTEGRATION

Presented by Monique Thomas , Supernus Pharmaceuticals and Lori Peters, QPharma, Inc.

 

Those who attended last year’s Sharing Conference™ will remember that compliance expert Lori Peters from QPharma co-presented a well-received presentation on the topic of successful system and program implementation. This year, Lori will be joined by Monique Thomas, a sample accountability professional from Supernus Pharmaceuticals, and they will expand on last year's session by presenting on the topic of integration in terms of the "human element" – managing the expectations of, and facilitating collaboration between, the diverse groups of people impacted by an integration project. When preparing to build integrations between systems, life sciences companies may overlook the fact that the human element plays the most crucial role. It's an unfortunate reality that many system integration projects are inevitably doomed to fail – often, because they don't consider this critical component. In this workshop, these two skilled presenters will draw on their own professional experience to share best practices on the big-picture approach to facilitating a successful integration. Workshop areas of focus will include why many system integration projects are doomed from the start; how and when to engage stakeholders; the hidden costs of integrations; and how to minimize surprises to ensure success. Attendees will benefit from an increased understanding of how to optimize and streamline their integration processes, how to prepare for and address unexpected challenges, and much more. There will also be time allotted for Q&A so attendees should bring their questions and be prepared for inspiring conversation.

STAYING IN YOUR LANE: MANAGING THE DIFFERENCE BETWEEN SAMPLES VS. FREE GOODS

Presented by Lisa Butler, Novartis Pharmaceuticals Corporation and Teresita Weiss, J. Knipper & Company

 

Lisa Butler and Teresita Weiss are noted compliance specialists with the real-world experience to deliver this insightful presentation. It will appeal to both compliance and sampling operations participants and will examine various types of free drug programs that are not included in sampling programs. Workshop attendees will get firsthand knowledge on this often confusing topic with insight into the purpose of a free drug program and what to address and consider when approached by colleagues who are considering implementing a free drug program. The format will include a Q&A session at the close of the presentation to maximize audience interaction and value, so have your questions ready!

BALANCING AUTHORITATIVE SOURCED AND PROFILE LEVEL CUSTOMER DATA – HARMONIZING COMPLIANCE WITH BUSINESS REQUIREMENTS

Presented by Kevin Johnston, Synergy Pharmaceuticals and Gregory Ungemach & Jennifer Valentine MedPro Systems

 

It’s true that there is an abundance of information available about Healthcare Providers (HCPs) and Healthcare Organizations (HCOs). Data from authoritative sources, such as state licensing boards, provides required information for compliance purposes. Public profile information can be qualified to augment regulatory data to maintain compliance while facilitating business operations. So, how do you maintain the integrity of compliance sourced data while leveraging provider profile information? Accomplished subject matter experts Kevin Johnston, Gregory Ungemach and Jennifer Valentine are prepared and eager to explain. Their revealing presentation will define and explore the roots of both authoritative data and profile level data. Workshop attendees should bring their questions and be ready for an informative mix of compliance information, HCP data realities, and practical field-based best practices.

SPEND LAWS AND GIFT BANS: STATES AND FEDERAL AGENCIES

Presented by Virginia Fitt, Senior Counsel, GlaxoSmithKline

 

The increased focus on pharmaceutical pricing and opioid prescribing habits in the external political environment have resulted in significant changes to laws and regulations on manufacturer spending and transparency. This workshop will take attendees through the gift bans, reporting laws and transparency initiatives regarding manufacturer spend. Intended for both those new to transparency reporting and seasoned experts, accomplished compliance industry specialist Virginia Fitt will provide an overview of laws and regulations that have necessitated data and information reporting from manufacturers for several years, as well as walk through the patchwork of state requirements. We will engage in in-depth looks at recent changes and discuss potential future trends and enforcement issues. Attendees will have an opportunity to interact to share successes, challenges and lessons learned navigating the collection of overlaid requirements in a quickly changing environment.

THE STATE REGULATORY ENVIRONMENT: FULL DISCLOSURE

Presented by Tom Lederer, Merck & Company and Brian Van Hoy & Mark Adams, G&M Health, LLC

 

There’s lots of talk these days about the state regulatory environment and how to stay on top of all the information. This new workshop is brought to you by three veteran compliance experts who spend their days in this complicated arena: Tom Lederer from Merck and Mark Adams and Brian Van Hoy from G&M Health. Their presentation will focus on the proliferation of state regulations that currently exist, highlighting those which were recently passed; those most impactful on industry; and, those with legislative action pending. Topics to be discussed include disclosure reporting (transfer of value, samples), price reporting, employee licensing and registration requirements, compliance program requirements, and at a micro level, the emergence of jurisdictional requirements. A sampling of recently passed regulations will also be addressed from implementation and operational perspectives. Conversation will also include state sample distribution regulations and the complexity their uniqueness creates, with special attention on loss reporting requirements and the variation of what —and when—reporting is required. The complexity of these regulations hinges on the distinct and subtle differences that exist from one requirement to the next. At a minimum, the pharmaceutical industry should prepare itself for this trend to continue, and how you manage these emerging issues will be key to remaining compliant. Don’t miss this fast-paced, chock-full learning session!

BUILDING A CULTURE OF COMPLIANCE WITH YOUR SALES FORCE

Presented by Lora Posey, Mission Pharmacal and Mark Jara RxS LLC

 

It’s no surprise to anyone that Sales and Compliance don’t always align and rarely do they have the same goals in mind. Presented by Lora Posey of Mission Pharmacal and Mark Jara of RxS LLC, these two experienced industry professionals will offer both the field force and vendor management perspectives, providing valuable insight and strategy examples from both sides. Presenters will discuss how it's possible to instill compliance without impacting sales and they’ll examine tactics and processes at various levels on how to keep compliance front and center. In addition, they’ll review all levels of a sales structure from Executive to Field Staff and provide strategies that will educate and foster a culture of compliance at each level. Workshop attendees should anticipate a lively exchange on why building a culture of compliance doesn’t mean sacrificing sales initiatives… it means success!

STRATEGIES FOR SETTING DEFENSIBLE SIGNIFICANT LOSS THRESHOLDS (SLTs)

Presented by, Mark Faloon, Takeda Pharmaceuticals U.S.A., Inc. and Paul W. Hamby, IQVIA

 

Title 21 CFR Part 203 requires pharmaceutical companies to have policies and procedures in place to identify “significant loss” of drug products, yet the Food and Drug Administration (FDA) does not specify what amount of loss should be considered “significant.” Instead, the FDA has indicated that the threshold level of what constitutes a significant loss will necessarily vary depending on such factors as the size of a company and the value of its total inventory, the accuracy of a manufacturer’s or distributor’s system for tracking sample distribution, and the circumstances surrounding the loss. Mark Faloon and Paul Hamby are two excellent presenters, well-experienced in the pharmaceutical industry, and knowledgeable on what you need to know in setting SLTs. This workshop has been designed to examine the various factors that should be considered when setting SLTs for a pharmaceutical company’s various drug products.  Statistical techniques, risk- based approaches, analysis of past sampling behavior, corporate thresholds vs. SLTs, recommendations on frequency of reviewing and “resetting” SLTs, and other factors will all be discussed and examined in this interactive workshop. Audience participation will be encouraged to facilitate dialogue of “best practices” and “lessons learned” by attendees.

PHARMA COMPLIANCE: A PROACTIVE APPROACH

Presented by, Dr. Carlos Tessi, MD, VP, Compliance, Shionogi Inc.

 

The Sharing Alliance™ is excited to welcome Dr. Carlos Tessi back to the Sharing Conference™. Dr. Tessi has over 30 years of experience in global pharma, having worked in a variety of different medical, marketing, and management roles.  He is recognized as a proven leader in Pharma Ethical Business Practices & Compliance. His accomplishments include developing a strategic vision for ethical business practices and compliance, simplifying and enhancing compliance systems and processes, identifying gaps, effectively assessing risk, and providing appropriate risk mitigation strategies. Dr. Tessi has been active at the IFPMA’s Code Compliance Council, presented at WHO’s Program for Good Governance in the Pharma sector and is a faculty member at the Seton Hall University Healthcare Compliance Certification Program. Well regarded as an industry expert, Dr. Tessi offers invaluable guidance on how to build and maintain an effective compliance program. Workshop attendees will learn how the three elements of a Commercial Compliance Program will help them build a risk management framework to assess, prioritize and mitigate business risk. Recognizing that companies’ compliance programs are in different stages of development, he will explain how you can present your compliance program throughout your organization in a way that it is perceived as a competitive advantage. This approach will help business leaders understand that compliance is not the sole responsibility of one department, but shared by all employees. Dr. Tessi’s presentation will also stress the importance of clear, consistent, and regular communications, and the critical need to be at the table at the earliest stage of all new initiatives or programs. It will define program governance, reporting structure and individual roles within the Compliance organization in big, medium and small companies, as well as the need to establish priorities and allocate resources based on evolving risk. Also covered will be the benefit of technology to improve existing processes; being more effective with fewer people; and generating information that is suitable for auditing and monitoring.

CORPORATE SECURITY AND RISK AVOIDANCE: PROTECTING YOUR COMPANY'S ASSETS

Presented by, Charles Washington, CFE, CICA, CPP, Pfizer

 

Have you ever stopped to consider that corporate security is more than the officers who ensure that you and your colleagues are authorized to enter the premises, or more than the staff that comes to your aid when you are in distress in the workplace? From security management to anti-counterfeiting to information security to anti-fraud, corporate security professionals protect all the assets of your company, so that you can do what you do best – save lives! This interesting look at an important topic is brought to us by noted security expert Charles Washington, Director, Fraud Investigation Group, Pfizer. Charles will provide an insight into corporate security from a perspective that rarely is encountered. Attendees will see how fraud could affect 10% of all the revenue coming into your company and will learn why counterfeiting has practically become the crime of the century. You’ll also hear more on how counterfeit drugs pose a significant risk to public health and safety and find out what the pharmaceutical industry is doing in the fight over the abuse of prescription drugs in the marketplace. This will be an interactive workshop where attendees will explore the values of developing collaborative relationships with corporate security and leverage those relationships to achieve their own compliance objectives.

STANDING ON THE SHOULDERS OF TECH GIANTS

Presented by, Phil Eng, Director – Sr. Digital Advisor, Microsoft Digital

 

It isn’t news that life sciences are interested in digital technology. After all, the earliest application of telemetry-based remote health monitoring was by NASA during the race to the moon. AI (Artificial Intelligence) was meant to help healthcare in the 1950s, reborn in the 1980s and now again. What is different now is the availability of that technology and the rate of change for how life sciences ingest that digital technology. What once was a daily injection for diabetes is now an Intelligent MedDevice using AI that adjusts to the person 24 hours a day. What once was a compound produced for all is now the patient’s own immune system T-Cells that are re-engineered with AI and digitally tracked for the single leukemia patient. This exciting workshop will explore the current state of AI and the implications of a precision medicine’s creation to save a leukemia patient thru the use of ML (Machine Learning) and the personalized digital supply chain. The Sharing Alliance is happy to welcome digital industry expert Philip Eng to the Sharing Conference™ this year. Don’t miss this chance to find out more about the convergence of healthcare and technology from someone who spends every day working in this new arena, helping to make history on the frontiers of both industries as they strive to increase the length and improve the quality of human life.

FUNDAMENTALS OF MONITORING PRESCRIPTION DRUG MARKETING PROGRAMS

Presented by: Teresa Farmer, MBA, Otsuka America Pharmaceutical, Inc.

 

A strong corporate culture is essential for an effective prescription drug marketing program. This new workshop will explore recent trends centered around monitoring prescription drug marketing programs at both the federal and state levels. Teresa Farmer is a long-standing compliance professional with a wealth of knowledge and industry experience. Areas to be covered include: the importance of educating and training the field sales force to ensure adherence to state and federal laws; how to proactively implement processes to assist with internal data reporting; and, how to effectively communicate and collaborate with key internal and external stakeholders. Discussion will also incorporate managing the various business requirements such as theft/loss by state and identifying what roles and responsibilities your company and key partners (such as distributors) have with compliance and support of prescription drug marketing programs.

Q&A will be part of this interactive presentation, so come with your questions and be ready for an in-depth conversation on these critical fundamentals.

 

CMS OPEN PAYMENTS DATA – WHAT IS IT GOOD FOR?

Presented by: Isha Arora, Compliance Manager, Horizon Pharma

 

Now that we have several years of reporting under our belts, there is a wealth of information in the Federal CMS Data available to the public in the Open Payments System. The data continues to grow and evolve. So the question becomes, now that we have it, what is it good for? Industry expert Isha Arora understands how compliance analytics allows for the opportunity to identify and mitigate issues proactively. By applying critical thinking to the analytics, Ms. Arora will review aspects of the data using real-life examples to explore what the data reveals and ultimately how it can help drive better business decisions. By “keeping it simple”, workshop attendees will see examples of how manufacturers can use their own Open Payments data to monitor internal compliance and gain business intelligence. Discussion will also include the rewards and risks of mining Open Payments data, what to look for and what to avoid when using the data within your own organization.

DSCSA AND THE COMPLIANCE PROFESSIONAL

Presented by: Robert Celeste, Founder, Center for Supply Chain Studies and Jill Feldman, AD, Quality & Compliance, Medac Pharma

 

It’s hard to believe, but the pharmaceutical industry is already two years into the implementation of the Drug Supply Chain Security Act (DSCSA). And just like the Prescription Drug Marketing Act (PDMA) tested our industry back in 1987, the DSCSA challenges the way we do business today by requiring commercial product traceability from the point of manufacture to the end user. This spirited presentation will include an overview of the regulation, labeling, and current challenges, along with a look at what’s coming next and why you will want to be prepared. Jill and Bob, both long-time and well-respected industry professionals, will explore the parallel processes between the sample and commercial product distribution, including reconciliation and accountability; expired product return or destruction; transaction history and serial number verification; post-market pharmacovigilance and recall management; and traceability of free goods used in hospitals and clinics. They’ll end the session with discussion on some of the commercial applications of a 2D barcode being pursued that provides safety information to patients and helps commercial groups understand where the product is being used.

THE OPIOID CRISIS: SUSPICIOUS ORDER MONITORING’S ROLE

Presented by: Joseph Tomkiewicz, Manager DEA Compliance, Teva Pharmaceuticals

 

Alliance Members will remember Joe’s outstanding workshop at last year’s Sharing Conference: Selling and Promoting High Risk Drugs. For 2018, Joe’s back by popular demand to examine the Opioid Crisis and the role that Suspicious Order Monitoring (SOM) plays. Recent enforcement actions taken against opioid manufacturers and distributors have zeroed in on failures of companies’ suspicious order monitoring programs. The US Drug Enforcement Administration requires handlers of controlled substances to take measures to identify their customers, understand the normal and predictable transactions for those customers, and identify those transactions that are outside those normal patterns or suspicious in nature.

In this dynamic workshop presentation, Joe will analyze why suspicious order monitoring is crucial, as well as take a look at the recent rulings and enforcement actions taken against DEA registrants. Attendees will learn how an effective Suspicious Order Monitoring program can be achieved; what red flags they should be looking for; methods for clearing legitimate orders; and how far down the rabbit hole you must go. Q&A will top off this well-timed and enlightening workshop, so bring your questions!

RIDE ALONGS AND SPEAKER PROGRAMS

Presented by: Alex Celius, Pacira Pharmaceuticals and Scott Tinkel, Shire.

Moderated by Steve Conn, Genesis Logistics

 

Sales Representatives serve as the pulse of an organization, out there in the real world doing business meeting and educating Healthcare Professionals. Every day, these individuals walk the fine line between “doing their job” and “doing their job compliantly”. How can one help their Representatives not cross that “fine line” while doing business?  Two major areas which can help build a strong foundation for compliant behavior are the Ride Along and Speaker Program Monitoring. This workshop will review and discuss tips around conducting that effective Ride Along and Speaker Program so the assets of an organization are not compromised.

SAMPLE STRATEGY AND BEING A STRATEGIC BUSINESS PARTNER

Presented by: Jeff Wilcox, Horizon Pharma

 

This session will explore a variety of ways that you can proactively partner with your product teams to add value and insights to their Brand Plans in a compliant manner.  There are many collaboration opportunities from launch to mature products across all of your channels: call center, hand carry, product web sites and co-promotion partners.  The first place you see a consolidated view of your sample disbursements shouldn’t be in your annual filing! Learn how and why you should be actively participating in more discussions at your company on an ongoing basis.

A LITTLE BIT OF THIS, A LITTLE BIT OF THAT: FDA REGULATION OF COMBINATION PRODUCTS

Presented by: Alan Minsk, Partner, Arnall Golden Gregory

 

If you are a pharmaceutical professional newly embarking on the adventure of medical devices, what are the essential regulations needed for compliance? While the success and potential of combination products in advancing patient care and making treatments safer and more effective have contributed to its rapid market growth, the regulatory framework for combination products can raise a variety of challenges for the industry. Join us as this workshop will introduce you, or further your knowledge as to what you need to know about the world of combination products.

OPEN FORUM

Deb Segura, Sharing Alliance Executive Director and Kelly Pryslak, Janssen Pharmaceuticals/Alliance VP

 

There’s a reason why our Open Forum sessions are also known as “Sharing Forums”. Industry attendees and vendor partners get together for open discussion on any and all compliance-related topics. This year our Open Forum meetings are happening early morning – 7am both Monday and Tuesday for pre-breakfast discussion with plenty of coffee and conversation. So bring your compliance questions and challenges to the Open Forum area in the Grand Ballroom Exhibit Hall – we’ll be waiting for you!

Content subject to change.

Back to Top