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.
Take a look at some of the workshops already scheduled for our conference in September:
STATE UPDATE – HOT TOPICS & EMERGING TRENDS
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 nuisances 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.
PAP AND FREE GOOD PROGRAMS: FOLLOWING THE RULES OF THE ROAD
This workshop provides attendees with the opportunity to better understand the objectives, program management, and regulatory complexities surrounding Patient Assistance Programs (“PAP”) and other free goods programs. As part of this presentation, attendees will acquire insight on best practices and key compliance considerations for PAP and free drug programs for potential advisement of colleagues who are considering such programs.
The session will cover essential learnings for newcomers as well as insights for the seasoned attendees. The format will include a Q&A session at the close of the presentation to maximize audience interaction and value.
DEA REGULATIONS – RECENT UPDATES AND CHANGES
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. During this interactive learning session attendees will have the opportunity to discuss their challenges and learn how other companies are adjusting the proposed changes.
THE IMPORTANCE OF HIGH-QUALITY INVESTIGATIVE REPORTS
It is easy for an outstanding compliance investigation 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.
CREDENTIALING – WHAT’S THE STANDARD?
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? Learn about the Consortium for Universal HealthCare Credentialing, the first American National Standard (ANSI) for supplier credentialing and what it means for you.
COMMON MISTAKES WHEN SUBMITTING A COMBINATION PRODUCT APPLICATION
In this workshop, you will hear some common mistakes that companies, whether pharmaceutical or medical device firms, make in preparing combination product submissions to FDA. Concerns, such as design controls, management responsibility, traceability documentation, stability testing and expiration dating, of both drug and device companies will be covered.
Discussion will include expectations for combination product submissions and the actions that you need to take.
PDMA, THE FUNDAMENTALS
Everyone’s invited to join this interactive workshop, whether you are new to this area or just want a comprehensive review of The Prescription Drug Marketing Act. Focus areas will include: understanding the history, purpose, terms, and key elements surrounding the PDMA. The goal is to provide you with necessary information and share our knowledge to assist you in staying compliant with all the rules and regulations that are so important for a successful program.
ARE YOU PREPARED TO SURVIVE THE CMS MID-LEVEL REPORTING TSUNAMI?
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 presentation will cover the background information on the changes to the Physician Payment Sunshine Act and the data challenges unique to these professions. We will discuss the use of data analytics, management, and reporting solutions to help you not only survive, but ultimately benefit from this new requirement. The presentation will seek to make our points with a combination of regulatory information, data examples, and business insights.
QUALITY STRUCTURE AND PROCESS IMPROVEMENT
Quality structure and process improvement are key to the success of any pharmaceutical manufacturer in today’s rapidly changing environment of going from product development to product commercialization. Be they applied internally or to third party providers being 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 be they internal stake holders or third party providers are operating in the environment that provides a “Quality Structure” that supports regulatory compliance. Additionally the structure needs to incorporate and support process for addressing key issues and enhancing improvement short and long term to afford an organization with insulation from liability and efficiency gains. Topics will include processes and tools used in a QMS (Quality Management System) and more.
THE POTENTIAL COMPLIANCE RISK OF USING UNSTRUCTURED AND LATENT DATA
Todays’ technology tools make it simple to set up a system that utilizes integrated, up to date, compliance required data. However, some systems not only allow for the “creation” of a manual processes, but at times, they are also subject to using data that is not up to date. For instance, an online system allows a user to create an unstructured “blank” SRF that will be bounced against a validated source. Post form creation, the validation will identify missing, incomplete or incorrect data. This is all well and good if the data source is current. Keep in mind, these forms can come from a myriad of sources. Blank web forms, Fax SRF’s and believe it or not, blank Rep utilized SRF’s
In our workshop, we will examine what an unstructured form is, and discuss the inherit compliance risk for using this form. We will also discuss the importance of keeping all compliance related data sources up to date. We will explain the process of system & data integration and the business processes used to extract, validate, from disparate sources into meaningful and valuable information.