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

1:30pm Monday Oct. 15 thru

3:00pm Wednesday Oct. 17, 2018

MGM National Harbor • Oxon Hill, Maryland

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!

DSCSA AND THE COMPLIANCE PROFESSIONAL

Presented by: Robert Celeste, Founder, Center for Supply Chain Studies

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

 

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 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. This workshop will review why suspicious order monitoring is needed as well as the recent rulings and enforcement actions taken against DEA registrants.

BUILDING A CULTURE OF COMPLIANCE WITH THE SALES FORCE

This is an important workshop for attendees who want to increase and adopt strategies that couple sales initiatives with an overarching compliance mindset. Sales and Compliance don’t always align and have the same goals in mind. Building a culture of compliance doesn’t usually mean sacrificing sales initiatives and success. Learn how to instill compliance without impacting sales. We will review tactics and processes at various levels on how to keep compliance front and center.

CMS OPEN PAYMENTS DATA – WHAT IS IT GOOD FOR?

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 question is, how can it be utilized? This workshop will review aspects of the data using real-life examples to explore what the data reveals and the benefit and associated risks of data mapping.

CORPORATE SECURITY AND RISK PROTECTION – PROTECTING YOUR COMPANY’S ASSETS FROM WITHIN

Corporate Security is more than the officers who ensure that you and your colleagues are authorized to enter the premises, or the staff that come to your aid when you are in distress in the workplace.  From Security Management to Anti-Counterfeiting and 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 workshop will provide a glimpse into Corporate Security from a perspective that you rarely encounter.

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

There is an abundance of information available about Healthcare Providers (HCPs) and Healthcare Organizations (HCOs) through various subscription databases and public websites. The challenge, however, lies in the fact these sources are diverse, diffuse and vary widely in authority. Neither does it help that many of these aren’t easy to navigate, updated on different schedules and can’t readily be linked. This presentation will define and explore the roots of both authoritative data and profile level data and discuss the best practices which should be considered in their usage.

THE HUMAN ELEMENT OF SYSTEM INTEGRATION

When preparing to build integrations between systems, life sciences companies may overlook the fact that the human element plays the most crucial role of all. It's an unfortunate reality that many system integration projects are inevitably doomed to fail - often, because they don't consider this critical component. You'll learn 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; and more!

PREPARING TO SAMPLE COLD CHAIN PRODUCT

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.

RIDE ALONGS AND SPEAKER PROGRAMS

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

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.

SPEND LAWS AND GIFT BANS: STATES AND FEDERAL AGENCIES

This past year and a half has seen significant changes to the transparency landscape at the city, state and federal levels. This workshop will take attendees through the gift bans, reporting laws and transparency initiatives regarding spend and sampling, sales representative licensing and state notifications. Using a timeline as a backdrop, we will walk through state requirements, providing an in-depth look at recent city and state laws and an overview of laws and regulations that have necessitated data and information reporting from manufacturers for several years.

THE STATE REGULATORY ENVIRONMENT: FULL DISCLOSURE

This workshop will highlight and educate our audience on the proliferation of state regulations that currently exist, were recently passed, those most impactful on industry, and those with legislative action pending. The array of subject matter ranges from transparency reporting (transfer of value, samples), price reporting, compliance program requirements, and at a micro level, the emergence of jurisdictional requirements. A sampling of the recently passed regulations will be addressed from implementation and operational perspectives. The complexity of these regulations hinge 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. How you manage these emerging issues will be the key to remaining compliant.

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

This workshop will deliver an insightful presentation that will appeal to compliance and sampling operations participants with its review of various types of free drug programs that are not drug sampling programs. As part of this presentation, attendees get firsthand knowledge and experience on the free drug program purpose and what to address when approached by colleagues who are considering a free drug program. The format will include a Q&A session at the close of the presentation to maximize audience interaction and value.

STRATEGIES FOR SETTING DEFENSIBLE SIGNIFICANT LOSS THRESHOLDS (SLTs)

Title 21 CFR Part 203 requires pharmaceutical companies to have policies and procedures in place to identify “significant loss” of drug products. 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. This workshop is designed to examine the various factors that should be considered when setting SLTs for a pharmaceutical company’s various drug products.

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

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.

MONITORING YOUR PRESCRIPTION MARKETING PROGRAM

The workshop will provide an overview of recent trends around Prescription Drug Monitoring at a Federal and State Level.  Information will include the importance of educating and training your 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 external stakeholders such as pharmacist. The workshop will focus on managing the various business requirements such as Theft/Loss by state, identifying what roles and responsibilities your company and key partners such as distributors have with compliance and support of Prescription Drug Monitoring.

Content subject to change.

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