The 27th annual

Sharing Conference

Clearing a Path to Compliance

1pm Sunday, Oct. 22 through 4pm Tuesday, Oct. 24, 2017

COMPLIANCE • TRANSPARENCY • PDMA • OIG

Baltimore

Marriott Waterfront

700 Aliceanna Street

Maryland

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

Workshops

“The Compliance Certification Board (CCB)® has approved this event for up to 17.7 CCB CEUs. Continuing Education Units are awarded based on individual attendance records. Granting of prior approval in no way constitutes endorsement by CCB of this event content or of the event sponsor.”

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The Sharing Conference is the premier learning and sharing event for pharmaceutical, medical device and biotech compliance professionals. It’s also the best investment of time you can make for your own professional learning.

 

We offer attendees a variety of opportunities for intensive learning experiences through our general sessions, workshops, speed learning sessions, open forum group discussions and exhibit hall conversations with vendor partners. Our conference provides an excellent way to expand your knowledge in subject areas that are critical to you while also introducing you to hot, new topics that may be on your horizon.

 

Field Monitoring

Presented by:

Sean Hickson, Director, Ethics and Compliance, Novartis Pharmaceuticals Corporation

 

Whether or not you have been under a Corporate Identity Agreement (CIA), keep in mind that a good compliance program includes a robust component on Field Monitoring. The most recent CIAs call for monitoring on specific activities such as sampling, speaker programs and interactions with Practitioners. If you want to be up to speed on meeting this CIA requirement, the Field Monitoring and Training workshop can provide the assurance you need, with content that includes:

 

 

After the conference, attendees will be invited to refresh their memories and test what they've learned with an online review and follow-up exam. Details on how to receive a "Certificate of Training" will also be explained during the workshop.

 

This is the sixth compliance training module offered by the Sharing Alliance. Conference attendees (Alliance Members) are also invited to access our other training sessions on Sample Compliance, Sunshine/Transparency, Fraud & Abuse, Investigations and DEA/Controlled Substance Act. You can find these training programs in the Members Only section of the Alliance website. Please note that the objective of the Compliance Training Session is to provide a practical, educational resource and is not intended to replace, supersede or contradict any compliance training, corporate guidelines or SOPs that are mandated at any individual attendee's organization.

 

Ensuring Compliance in Sample Delivery Processes

Presented by:

Stephanie Husted, Celgene

Steve Conn, Genesis Logistics

 

How up to date and relevant is your current sample delivery process?
Are you thinking about a new sample delivery program, or in the process of developing one?

In this workshop, you’ll get sample compliance delivery insights from two experienced industry professionals on key program factors such as:

 • Best practices for delivery documentation

 • Aligning current processes to company policies and procedures

 • Documented legal interpretation of regularities

 • Damaged goods - rejected or accepted and returned

 

Join us and learn about delivery and managed goods programs and the many elements you  need to consider. You will enjoy this light-hearted approach to learning. Come play "PDMA family feud" and learn first-hand about some of the management practices initiated and implemented by your colleagues.

 

Avoiding Icebergs: Practical Tips for Conducting Effective Internal Corporate Investigations

Presented by:

Kenneth R. Piña, SVP, Chief Legal & Compliance Officer and Corporate Secretary, Pernix Therapeutics

 

State and federal agencies anticipate that companies have an effective and documented program in place when internal corporate investigations are being conducted. Ken Piňa has the substantial experience required to offer attendees some practical perspectives for evaluating their current programs, including oversight considerations. This informative discussion will include:

 

Compliance 101 for Pharmaceutical & Medical Device Professionals

Presented by:

Jill Feldman, Medac Pharma

Marc Chester, Howell Marketing Services

 

Wondering how your colleagues are handling questions about new legislation? Maybe new compliance challenges have suddenly fallen under your daily responsibilities and you’re not sure what’s best practices? Regardless of what brings you to this workshop, this is the session that will bring you up to speed.

 

Jill Feldman and Marc Chester are experienced presenters with the backgrounds and credentials that ensure that they’ve been there. Like you, their work days consist of questions related to government transparency tracking and reporting requirements; adherence to OIG guidelines; the requirements of the Prescription Drug Marketing Act (PDMA) regulations; and more. These two industry professionals have the know-how to find the answers and keep you pointed in the right direction.

 

Questions will be happily accepted during this workshop presentation. You will have an opportunity to submit questions anonymously in advance of the Sharing Conference or you may bring them with you to the workshop for dynamic discussion.

 

Culture, Ethics and Compliance

Presented by:

Ela Bochenek, Assistant Dean Graduate and Professional Education, Seton Hall University School of Law

Carlos G. Tessi, MD, Vice President, Compliance, Shionogi Inc.

 

This workshop presentation on the culture of compliance, led by two consummate compliance professionals, will focus on value-driven versus rules-driven compliance practices, with an evaluation of why compliance is important for business for both high performance and high integrity.

 

Data Integrity: Keeping Up with HCPs on the Move

Updates and changes in Health Care Practitioner (HCP) information can cause annoying slow-downs. Even worse, they can result in non-compliance. You need to be certain that you have the current and correct HCP specialties, licenses and addresses. You need to be well informed about the associated costs and risks.

 

In this workshop, two subject matter experts will discuss:

 

DEA: Selling and Promoting High Risk Drugs

Presented by:

Joseph Tomkiewicz, Manager, DEA Compliance, Teva Pharmaceuticals

 

Skilled Diversion Operations and DEA Compliance professional Joe Tomkiewicz will present this timely topic and share why achieving an effective Suspicious Order Monitoring (SOM) Program has often been compared to trying to hit a moving target.

 

This lively presentation will examine how ongoing enforcement may obliterate previously accepted methods of monitoring suspicious orders due to the abuse of new diversionary methods and new products.

 

From vendor, internal departments, distribution and other perspectives, workshop attendees will hear about methods of staying ahead of abusers to reduce the possibility of products ending up in the wrong hands. Workshop attendees gain a new understanding of the value of documentation and written procedures around anti-diversion activities which can minimize the potential of adverse enforcement actions.

 

Q&A will top off this timely and informative workshop, so bring your questions!

 

Ensuring Quality and Product Safety in Cold Chain Distribution

Ensuring product quality and patient safety is vital in our industry. Transportation of cold chain products presents specific challenges.  Attend this workshop to learn from industry experts about new technologies, product solutions and best practices to support your operation. Participants will come away with new information on how to meet challenges and mitigate risk.

 

Fraud and Abuse of Co-Pay Cards, Coupons and Vouchers

Presented by:

Alan G. Minsk, Alliance Legal Counsel and Partner, Arnall Golden Gregory LLP

Elizabeth A. Mulkey, Associate, Arnall Golden Gregory LLP

 

This is an important workshop for attendees who would like to increase their understanding of the high risk of fraud and abuse when offering co-pay cards, coupons and vouchers. Skilled co-presenters Minsk and Mulkey bring their strong backgrounds and expertise to this lively session. They’ll examine all that can be gained when you apply project management tactics to the program roll out of co-pay cards, while monitoring oversight of redemption data. Early preparations assist in ensuring verification of the redemption data and decrease the likelihood that there will be diversion.

 

Attend this workshop and you’ll see how to be better equipped to deal with possible fraud and abuse challenges that often stem from the use of co-pay cards, coupons and vouchers. There will be discussion on how to control eligibility, watch for trends, and track redemptions and distributions – all important aspects of this fraud and abuse compliance puzzle.

 

Hospital Credentialing Risks

While you may have heard the term “credentialing” used within our industry, it may not be clear what it means. How does a sales associate become credentialed to access a hospital or institution? Many diverse internal and external business areas must be involved to resolve the complexities of the credentialing process. In this workshop we will explore what is required to be credentialed and the risks to the manufacturer if noncompliant with company policies and procedures.

 

New Technologies for Data Management

Data: it’s all around us. So how do we manage data among our sales force and home office personnel? And with all the data we have available, what can we do with it? What should we be doing with it? What new, innovative technologies can help us visualize the data? To answer these questions and more, join us as we explore technologies to make our workload a little easier.

 

Ohio TDDD: A Framework for Complying with New State Regs

Ohio. Everybody is talking about it. What are the TDDD regulations as they exist today… and what can we do about them?

 

This newly-added workshop will present a comprehensive review of the recent Ohio Terminal Distributor of Dangerous Drugs (TDDD) legislation impacting the distribution of all prescription drugs in that state. Presenters will discuss the regulations as they are today, compliance considerations, and how to monitor the legislation’s unique problem areas. Workshop details will include a look at the amounts and categories of licenses, “campus licenses”, rep training, validation challenges, and requirements/penalties for HCOs, HCPs, manufacturers and distributors.

 

In addition, this workshop will provide a unique opportunity for Alliance members to be in on the ground floor of establishing best practices in response to the new legislation. We will consider Ohio TDDD as a framework to answer this question: What do you do when you’re faced with a new regulation?

 

By developing a strong rationale, building a detailed compliance process and creating the actions that support it, Ohio TDDD compliance can serve as the foundation for future state legislation compliance programs. And with the recent announcement of Nevada state regulations, and others very likely to follow, this learning session will provide even more valuable insight and a platform for discussion with colleagues facing the same challenges.

 

OIG Update: DSCSA, Work Plan and More

Presented by:

Meghan M. Kearns, Program Specialist, DHHS/OIG/OEI

Laura E. Ellis, Senior Counsel, HHS-OIG

 

“We don’t know what we don’t know” is a common refrain of compliance professionals. This workshop will clarify some of the unknowns, as attendees will hear the latest on compliance from OIG. Ms. Kearns will address OIG’s recent evaluation of wholesalers’ implementation of the Drug Supply Chain Security Act, as well as an update on the OIG Work Plan and Compendium of Unimplemented Recommendations. Ms. Ellis will cover OIG’s recent guidance for measuring compliance program effectiveness and how organizations may approach consideration of their own programs in light of the guidance.

 

Questions from the audience will be taken, so come prepared!

 

Project Management: Doing Business Using Lean Principles

There are certain components to every project - initiate, plan, execute, control, and close. In Six Sigma terms this would be - DMAIC (Define, Measure, Analyze, Improve, Control). Have you ever struggled to complete a project? You are likely working on a new project right now, or have one starting shortly down the road. This workshop will provide you with basic tools and skills you can use for a smooth, successful completion. You’ll see the basics put into action as we go through a real-life case study.

 

Preparing for a Transparency Audit

Centers for Medicare & Medicaid Services (CMS) has advised “Applicable manufacturers and applicable GPOs may be audited at any time for compliance to ensure the submission of timely, accurate, and complete reports of payments or other transfers of values made to physicians and teaching hospitals and physician ownership or investment interests.”  Avoiding CMS enforcement actions requires strategic planning and tactical solutions like mock transparency audits. This workshop will help you prepare for external audits.

 

Sampling Data Analytics

This workshop will provide you with key operational approaches in developing a sample data analytics program, with guidance on achieving organizational buy-in from all levels of the organization. An effective data analytics program relies on asking the right questions, getting the right information to the right people, and ensuring an effective remediation process is in place. This session offers important approaches to utilizing and sharing sampling data effectively.

 

Sampling Limits: How Much is Too Much?

The number of samples given to an HCP has always been an at-risk activity within the realm of sample distribution. Over-sampling an HCP can be an intentional activity which triggers a host of potential regulatory violations. Conversely, it can be a lack of coordination, poor or non-existence data feeds, weak monitoring systems, and a general lack of due diligence. Variables such as transaction limits, DTP and hand carry data, CSOs and co-promoters will all be addressed in this session.

 

State Legislation: Panel Discussion

Led by:

Marc Lavin, Pfizer, Industry Moderator

 

Featuring:

Bob Melillo, G&M Health

Judy Fox, QPharma

Teresita Weiss, J. Knipper

Jennifer Valentine, Veeva Systems

 

The moderator and panelists on this state legislation interactive panel all have the knowledge and first-hand experience needed to educate and foster a discussion about the ever growing and complex compliance regulations imposed by various states, and even some counties within a state.

Your participation in this panel discussion will increase your awareness of many aspects of state legislation including: state and county sampling laws; drug stewardship and take back requirements; state licensing requirements; and manufacturers' responsibilities and their response to the opioid crisis.

Our panelists are all industry experts immersed in state regulations on a day-to-day basis, putting them in a prime position to understand the implications of these compliance regulations and their impact on your daily responsibilities. You will have the opportunity to submit questions ahead of time or bring your questions to the session. You’ll get answers during the session, and you’ll leave with suggestions on where to find support materials and resources that can provide answers long after the conference ends.

 

Successful Compliance Training Strategies

Companies must adopt new training strategies to remain current, compliant and competitive. Learners do not start at the same point in comprehension or ability, and one size probably does not fit all.  Have you struggled with adapting new technology and modalities for various trainees? How can you adapt to the learning styles of Baby Boomers vs. Generation X vs. Millennials? This workshop will cover training methods and strategies to reach varied audiences.

 

Techniques for Easing System Implementations

System implementations and enhancements are inevitable, necessary, time-consuming, and can sometimes be frustrating. How can you help your IT team better understand the business requirements of the system? Let us help you work with your key stakeholders, communicate your compliance needs to these stakeholders, and understand each group’s roles and responsibilities. Better yet, have your partners from IT, legal, operations and other teams attend the conference with you for an interactive, educational experience.

 

Wide Open Forum - PDMA/Transparency Compliance and More

Conference attendees value our “Sharing” Forums, which provide the opportunity to discuss any and all compliance-related subjects with conference colleagues in an interactive open forum. Our Sharing Forum discussions will include Transparency, PDMA/samples, and OIG Guidance … plus we’re “wide open” for any compliance related challenges our attendees want to talk about.

 

 

Learning sessions and schedule subject to change.