REUNITE WITH YOUR COMMUNITY TO OVERCOME THE UNIQUE RISKS & CHALLENGES ASSOCIATED WITH COMPLEX THERAPEUTICS

In this new, increasingly digital world, data has become a main currency. From data privacy at an individual level, to data monitoring and discovery at the broader organizational level, the compliance sphere and their involvement with data, is changing. During this Summit, attendees share best practices surrounding data protection and investigation, help uncover red flags within preexisting processes and set a tactical plan to enhance their compliance structure moving forward.

1. Data Privacy – Protecting the Individual:
   • With the rise of data privacy, understand the potential of an expanding compliance scope regarding how much access a compliance team has to employee personal information
     • Compliance has approval to access email communication, but what about text?
   • Discuss the increase of rigorous monitoring technology and the challenges that it creates in respecting data privacy
   • Learn how to balance regulations surrounding employee information protection with internal compliance requirements
     
     
2. Data Analytics and Capability – Protecting the Business:
   • Benchmark with colleagues on what they are doing within their own compliance programs to monitor data
   • Discover how to most effectively unleash and harness data to uncover issues including but not limited to, off label risk, outliers, fraud and policy violation
   • Collect strategies on how to interpret the data in a way that digs deeper and tells a greater story
     
     
3. Data Monitoring and Discovery – Merging Individuals & Business:
   • Uncover best practices surrounding employee monitoring, including their overall digital use and footprint (ie. social media)
   • Understand the transition between the monitoring and discovery stages, in the event of a government investigation

At the heart of the specialty pharmaceutical industry lies the patient, a main motivator for most of the folks working within this community. However, due to an increase of scrutiny surrounding patient support, services and interactions, it is now more important than ever for compliance teams to have a plan in place to mitigate risk. This Summit explores risks and compliance considerations associated with advocacy organizations, patient support and assistance programs, alternative funding and more. During this Summit, attendees uncover emerging enforcement trends and risks and collaborate with peers to benchmark leading frameworks in order to establish best practices for compliant patient interactions.

1. How to Compliantly & Effectively Work with Patients, Ad Boards and Advocacy Organizations
   • Break down the compliance team to determine which specific stakeholders should lead in engagement with patients and in turn, what their roles and responsibilities look like
   • Examine the concept of Ad Boards, both patient-led and non-patient-led and how to best foster complaint collaboration
   • Discuss the potential risk factors associated with patient relationships, such as patient compensation, fraud abuse and improper influence
     • What are the guard rails that can be put into place to avoid risk factors?
       
       
2. Uncovering Compliant Patient Support Programs & Services to Enhance Access
   • Benchmark with colleagues on what the patient support programs look like at their companies/for their specific products and delve into the specific functions that they serve (ie. education vs connectivity vs prior authorizations, etc.)
   • Examine the overall compliance architecture for Hub programs
   • Talk through the different guidelines that must be instated to ensure your patient support teams are remaining compliant when engaging with patients
     • Can they bring meals to the office? Can they visit the patient at their home? Do they have access to the Hub?
       
       
3. Critical Updates on Patient Assistance Programs & “Specialty Carve Outs”
   • Learn about industry best practices and analyze key PAP risk areas
   • Take a deeper dive into the new attack on alternative funding programs, including the associated compliance and ethics
   • Discover how to navigate programs moving forward and consider their effect on patient assistance