September 19-21, 2023
Boston Convention & Exhibition Center (BCEC),
Boston, MA
REUNITE WITH YOUR COMMUNITY TO OVERCOME THE UNIQUE RISKS & CHALLENGES ASSOCIATED WITH COMPLEX THERAPEUTICS
Bridge the gap between niche markets and industry standards to accelerate towards a solution catered exclusively for specialty pharmaceutical companies focused on rare, ultra-rare and orphan diseases.

Compliance Frameworks to be Addressed to Cultivate a Top Specialty Pharmaceutical Organization
Analyze Recent Enforcement Trends, Regulatory Actions and Pending Policies
- Hear directly from leading attorneys and enforcement agencies spearheading the charge against healthcare fraud
- Stay up to date on emerging enforcement areas and policy updates
- Explore the top trends on enforcement radars and discover why it should be on yours
Interactive And Intimate Conversations on Top of Mind Topics
- In-Depth Pre-Conference Workshops: Uncovering Data Challenges in the New Digital Era to Enhance Compliance Frameworks and Deep Dive into the Patient Continuum – Remaining Compliant whilst Emphasizing Patient Centricity
- CCO Luminary Panel—Top Compliance Challenges and Industry Trends Facing Industry Leaders
- Policy Update on Drug Pricing Transparency
- Reassessing the Relationship Between Medical and Commercial Teams
The Only Specialty Compliance Event Uniting Life Science Professionals
The team is hard at work recruiting the brightest minds in Life Sciences. The current company list of confirmed industry leaders joining the 2023 faculty include:
- Vertex Pharmaceuticals Inc.
- Immunogen
- Zai Lab
- Appellis Pharmaceuticals
- Flagship Pioneering
- MorphoSys US Inc.
- Boehringer Ingelheim USA Corporation
- Regeneron Pharmaceuticals Inc.
- Takeda
- Emergent BioSolutions
- And more!
UNRIVALED INDUSTRY LEADERS PAVING THE WAY AT SPECIALTY COMPLIANCE
Intimate & Interactive Workshops Designed to Challenge Your Thinking
Uncovering Data Challenges in the New Digital Era to Enhance Compliance Frameworks
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.
- 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
- 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
- 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
- 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
Deep Dive into the Patient Continuum – Remaining Compliant whilst Emphasizing Patient Centricity
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.
- 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?
- What are the guard rails that can be put into place to avoid risk factors?
- 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?
- Can they bring meals to the office? Can they visit the patient at their home? Do they have access to the Hub?
- 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
AN INSIDE LOOK AT OUR COMPLIANCE CONGRESS FOR SPECIALTY PRODUCTS COMMUNITY
Attendance by Company Type:
77%
Bio | Pharma
15%
Consultant | Solutions Provider
4%
Government
4%
Non-Profit | Higher Education

Connect and Network with Key Decision-Makers at the Compliance Congress for Specialty Products
Whether you’re looking to generate quality leads, showcase thought leaders, or reinforce your brand, collaborate with us to identify custom sponsorship opportunities to help you reach your business objectives.
For more information about custom opportunities to reach a qualified audience, please contact:
Derek Tagliarino: DerekT@informaconnectls.com | +1-212-600-3433