Workshops are specifically designed for commercial operations and compliance professionals, and offer learning and sharing on a variety of related topics. All sessions are planned with a strong focus on educational value and provide opportunities for sharing of best practices and lessons learned.
Here are the workshop summaries that we’ve got lined up for you for 2019. More will be added as our agenda is finalized.
CURRENT EVENTS - OPIOIDS: PREVENTING DRUG DIVERSION
Presented by: Joe Tomkiewicz, Teva Pharmaceuticals & Cathy Gallagher, IQVIA
The opioid epidemic is one of the deadliest public health crises in American history and one of the leading causes of death for Americans under the age of 50 years old. During this well-timed learning opportunity, our two experienced speakers will explore the history of the opioid epidemic and how we arrived at where we are today. This session will also examine how the opioid epidemic is impacting the pharmaceutical industry and cover some current legal activities being taken to combat it.
Time will be allotted for reviewing the results and responses to settlements of recent opioid lawsuits and what lies ahead for the industry.
Given the current regulatory environment surrounding the opioid epidemic, this workshop will certainly be one you won’t want to miss. Get your questions ready!
QUALITY STRUCTURE AND PROCESS IMPROVEMENT: THE KEYS TO SUCCESS
Presented by: Marc Lavin, Pfizer & Mark Mundy, Thermo Fisher Scientific
Quality structure and process improvement are key to the success of any pharmaceutical manufacturer in today’s rapidly changing environment of moving from product development to product commercialization. Whether they are applied internally, or to third party providers engaged to support an on-going process, these elements are tantamount to not only the success of gaining product approval, but ensuring that all those that may touch the processes (internal stake holders or third party providers) are operating in the environment that provides a “Quality Structure” and supports regulatory compliance.
Don’t miss this interesting workshop conversation where these two well-experienced industry experts will answer the following questions, and more:
- What is a Quality Management System (QMS) and what are the benefits expected from using one?
- What are the critical elements and tools included in a Quality Management System?
- What are the 8 steps in the Practical Process Improvement (PPI) problem solving process?
- How does PPI improve project outcomes?
Q&A will be included, too, so attend this workshop and be part of the spirited discussion!
DSCSA PHASE II – INTEROPERABILITY CHALLENGES
Presented by: Jill Feldman, Medexus Pharma & Bob Celeste, Center for Supply Chain Studies
The process of transitioning from the Drug Supply Chain Security Act (DSCSA) current Phase I requirements that went into effect 1/1/2015 to the electronic systems and processes required for Phase II interoperability going into effect November 23, 2023 will require significant, shared and collaborative efforts from all sectors of the pharmaceutical supply chain.
This presentation will examine the challenges posed by the DSCSA regulation, including the obstacles they face with the diverse solutions, technologies and architectures. How do the manufacturers, wholesalers and dispensers communicate the required information for product and stakeholder verifications without giving up company secrets like customers, markets and product distribution volumes?
We are excited to welcome back these two expert presenters to the Sharing Conference™ this year! Q&A will be offered to allow attendees time for discussion on this time-sensitive topic.
ARE YOU PREPARED TO SURVIVE THE CMS MID-LEVEL REPORTING TSUNAMI?
Presented by: Melissa Blaco, Regeneron Pharmaceuticals, Inc. & Jennifer Valentine MedPro Systems
The new regulation “Fighting the Opioid Epidemic with Sunshine Act,” expands the scope of reporting requirements under the Physician Payment Sunshine Act to include Advance Practice Nurses and Physician Assistants in the definition of a covered recipient.
Are you ready to manage the complexity and increased volume of data for these new requirements? What is the impact on business objectives, operational and compliance support?
This well-timed workshop presentation will cover the background information on the changes to the Physician Payment Sunshine Act and the data challenges unique to these professions. Our two accomplished presenters are ready to share their extensive experience in a spirited discussion on the use of data analytics, management, and reporting solutions to help attendees not only survive, but ultimately benefit from this new requirement.
This timely topic will be covered with a combination of regulatory information, data examples, and business insights – don’t miss this excellent presentation!
MONITORING AND AUDITING TO IDENTIFY POTENTIAL FRAUD IN PDMA SAMPLE TRANSACTIONS
Presented by: Teresa Farmer, MBA, Otsuka America Pharmaceutical, Inc.
This workshop will review Sample Transactions that are performed on a day to day basis to execute a company’s Sample Policy and Procedure. It will provide insights on actions you can take to validate completion of required procedures from a PDMA compliance perspective and how you can perform additional auditing and monitoring to reduce fraud risk related to PDMA Sample Transactions.
Successful auditing requires reviewing your monitoring process to ensure you are achieving the company’s desired outcomes. This can include working with internal auditors, providing additional training and tracking metrics related to PDMA risk. Successful monitoring requires a strong corporate culture with “top-down” expectation of adherence. The company culture should promote preventive actions through both early detection of potential fraud and development of corrective action plans.
We’re very excited to have industry Alliance Board Member, Teresa Farmer, as a presenter again at this year’s Sharing Conference™. Join us for this informative workshop!
THE POTENTIAL COMPLIANCE RISK OF USING UNSTRUCTURED AND LATENT DATA
Presented by: Claude Chester, Vertical Pharmaceuticals, LLC & Marc Chester, Howell Marketing Services
Using the technology tools available today makes it easier to set up a system that incorporates integrated, up-to-date, compliance-required data. And, while some systems allow for the “creation” of manual processes, they may be using data that is inaccurate or out-of-date, putting your compliance program at risk.
Our two knowledgeable presenters have the background and experience to explain how data authentication, data accuracy, data latency, data integration and real time data all have an impact on your compliance program. They will discuss the importance of keeping all compliance related data sources up to date and explain the process of system and data integration and the business processes used to extract and validate data from disparate sources into meaningful and valuable information.
Come ready with questions and be prepared to leave with plenty to think about!
FIELD FORCE MONITORING PROGRAMS: HOW SOLID IS YOUR RECORDS REVIEW PROCESS?
Presented by: Sean Hickson, Novartis Pharmaceuticals Corporation & Andrea Murphy, Novartis Oncology
Whether you joined us at the Sharing Alliance’s™ Short Course earlier this year or not, we’ll be continuing the field monitoring conversation in this workshop by discussing the several facets of conducting a Records Review of your sales representatives’ interactions with HCPs and HCIs.
The OIG has traditionally required pharmaceutical companies to establish and maintain a Records Review Process as part of an overall comprehensive Field Force Monitoring Program. Our two industry expert presenters will examine strategies based on their experience planning, executing and following up with various stakeholders throughout the process.
Don’t miss your chance to be a part of the discussion on this important compliance topic!
PAP AND FREE GOODS PROGRAMS: FOLLOWING THE RULES OF THE ROAD
Presented by: Andrew Weber, Bausch Health & Recie Bomar, KnippeRx Inc.
With more than 46 million uninsured Americans, and millions more considered under-insured, Patient Assistance Programs and other free goods programs have emerged in an effort to help patients obtain the medications they need.
For many pharmaceutical companies who offer these programs, the goal is to provide free or low-cost prescription drugs to indigent patients who qualify in the hope that it helps patients comply with recommended drug therapies.
In this workshop, our knowledgeable presenters will explain the similarities between PAP and Free Goods programs; explore best practices in implementing, managing and monitoring a program; and review vendor management, including auditing and oversight.
Q&A will offer attendees time for group discussion on this growing topic. Bring your questions, and plan on getting insightful answers!
PDMA, THE FUNDAMENTALS
Presented by: Debbie Tay, Vertical Pharmaceuticals & Steve Conn, Genesis Logistics
It doesn’t matter whether you are new to samples, new to the Sharing Conference™ or you’re just looking for a comprehensive refresher of The Prescription Drug Marketing Act, come join this fun and interactive workshop and you won’t be disappointed! Our knowledgeable and experienced presenters are ready to share their sample compliance expertise and help you better understand the history, purpose, terms, and key elements surrounding the PDMA.
The goal of this session will be to provide you with information and where you can find resources to assist you in staying compliant with all the rules and regulations that are so important for your program’s success.
There will be time to address your own questions in Q&A before, during and after the presentation. Put this workshop on your “must attend” list, and come talk PDMA with the professionals!
CLOUD COMPUTING: CHALLENGES AND OPPORTUNITIES
Presented by: Tracey Fama, GlaxoSmithKline & Mark Jara, RxS LLC
Cloud computing offers the promise of global access to nearly unlimited data at lower cost, but carries with it risks that, up until recently, could only be imagined.
Join our two skilled presenters as they help you navigate industry best practices for selecting and qualifying external technology partners to assist in developing systems for managing, sharing and protecting personally identifiable information and proprietary enterprise data.
Bring your questions and be ready for a lively discussion. This learning session will keep your cloud computing dreams from turning into nightmares!
PREDICTIVE ANALYTICS AND OPTIMIZATION
Presented by: Josh Pezzuto, Eyevance Pharmaceuticals & Jay Lambert, Synergistix, Inc.
With an expanding competitive promotional landscape, it is increasingly important to understand how the plethora of data we have at our fingertips can be optimized and analyzed… all while maintaining an eye towards compliance!
This timely interactive session, led by two well-respected subject matter experts, will explore the newest techniques in using data with a deterministic approach to predict and understand the desired and variable outcomes.
Workshop content will include the exploration of various solutions in data optimization and the latest tools being used for this purpose.
Come share your thoughts on this interesting topic in a value-packed, thought-provoking learning session.
HOSPITAL CREDENTIALING - STOP THE MADNESS, START THE STANDARDS!
Presented by: Margo Bear, AbbVie & Dennis Orthman, Consortium for Universal Healthcare Credentialing
This year’s Sharing Conference™ will feature an informative workshop on Hospital Credentialing, presented by knowledgable and insightful professionals Margo Bear from AbbVie and Dennis Orthman from the Consortium for Universal Healthcare Credentialing.
Highly individual hospital policies, background checks, drug screens, product service and competency letters, insurance, multiple training documents, immunizations, and the list goes on; there is no standard, no passport for credentialing…or is there?
In this workshop you’ll learn about the Consortium for Universal Healthcare Credentialing, the first American National Standards (ANSI) for supplier credentialing and what it means for you.
Q&A will top off this informative and enlightening workshop, so bring your questions!
MANAGING SUNSHINE COMPLIANCE AND STATE TRANSPARENCY REPORTING DATA
Presented by: Virginia Fitt, Alexion Pharmaceuticals
Spend transparency reporting under Federal ACA 6002 (“Sunshine”), along with numerous state requirements, necessitate business and legal decisions that are harmonized across your organization. System and services vendors must be coordinated as well to help ensure compliance with your company policy.
The Sharing Alliance™ is pleased to welcome back industry expert, Virginia Fitt, for this well-timed learning session.
Areas to be covered include:
- WAC disclosure laws
- Ongoing state updates
- Defining an “HCP” so data capture addresses all applicable state and federal laws
- Grey areas in the regulations that require legal interpretations
- Partnering with internal businesses to ensure an understanding of reporting requirements
- Mapping data to standards set by state and federal reporting requirements
- Data Monitoring and Analytics to manage compliance to state gift ban and spend limits
If your days are spent thinking about reporting rules, or you’re looking for some benchmarking guidelines, this is a workshop you won’t want to miss.
THE IMPORTANCE OF HIGH-QUALITY INVESTIGATIVE REPORTS
Presented by: Steve Haynes, Director of Operations, The Sharing Alliance™
It is easy for an outstanding compliance investigation to be de-railed by less than outstanding report documentation. How do you ensure a thorough and often complex investigation is properly documented?
This workshop will cover investigative report fundamentals, common reporting writing pitfalls, legal considerations, and government expectations. Through discussion, sharing of ideas and questions, and review of case examples and sample report templates, this workshop will give attendees an excellent understanding of how high-quality investigative reports should look.
As Alliance Director of Operations, Steve brings over 40 years of experience and enthusiasm to the Alliance board. He retired from FDA’s Office of Criminal Investigations in 1999 as Special Agent in Charge of their Investigative Operations Division. In the years since, he has worked closely with pharmaceutical clients and the Sharing Alliance™ on a wide range of corporate compliance matters, from investigations, regulatory compliance, and litigation support services, to federal court testimony as an expert witness on PDMA law.
STATE UPDATE – HOT TOPICS AND EMERGING TRENDS
Presented by: Nico Fiorentino, Sun Pharmaceutical & Mark Adams, G&M Health, LLC
State governments continue to target the pharmaceutical industry and city governments have and continue to throw themselves into the mix. These initiatives have different origins, different support groups, varying levels of support, and different outcomes. Successful initiatives add to the growing body of existing law. The nuances of each create implementation challenges, inefficiencies, and increase the burden on existing dedicated resources.
State legislation has established itself in areas of state licensing and transparency initiatives (emerging from the opioid epidemic), the imposition of compliance program requirements on manufacturers, and drug disposal and drug take back programs. Additionally, the sales and marketing restrictions and drug pricing initiatives have been established. Sample loss reporting, and HCP disbursement data continue to grow in scope.
While legislation continues to build and new laws are enacted, a growing concern relates to existing laws and regulations being enforced by state governments and/or its administrative agencies. Data gleaned from the Federal Sunshine Act can allege violations of the state’s gift ban law. Likewise, non-compliance with Federal law can be used as evidence a company violated state law. Other emerging issues is the omission of information on license applications as evidence a company violated state law, and the self-disclosure of non-compliance with state laws and/or regulations. You don’t want to miss this workshop as you will receive so much information to answer any state compliance situation or issue you may have within your organization.
DEA REGULATIONS – RECENT UPDATES AND CHANGES
Presented by: Lisa Butler, Novartis Pharmaceuticals Corporation & Joe Tomkiewicz, Teva Pharmaceuticals
Most of us are aware that the mission of the DEA is to prevent, detect and investigate the diversion of pharmaceutical controlled substances and listed chemicals from legitimate channels of distribution. As such, the DEA currently has several proposed rule changes planned that will impact the way companies currently do business.
Attendees of this workshop will learn about the modifications to the controlled substance quota approval process, the new single sheet DEA Form 222, suspicious order monitoring and several other proposed changes that may impact your day-to-day controlled substance activities.
Alliance President Lisa Butler and Alliance Board Member Joe Tomkiewicz will bring their extensive knowledge and insights to this important interactive learning session.
Workshop attendees will have the opportunity to discuss their own challenges and hear how other companies are adjusting to the proposed changes. So, come join your industry colleagues in a collaborative workshop that will surely be as engaging as it will be educational.