Dario Ghoddousi, Senior Director - Commercial Compliance & Quality Solutions, EMEA opened the Commercial Compliance breakout session at TechIQ Europe 2022. He explained how commercial compliance in pharma is in the process of moving towards an ecosystem that can deliver value to HCPs and insight to the company. Technology is now making it possible to transform compliance: from complex fulfillment of external regulation requirements, to the simple and automated generation of useful insights.

This transformation is taking place in the context of new technology-driven opportunities to move healthcare forward. Vast amounts of healthcare data are being captured digitally from a host of sources, and AI and ML are being harnessed to make it meaningful through the generation of evidence and intelligence. As innovations are identified to improve outcomes for patients and disease populations, the application of new knowledge is serving to improve population health and economic sustainability.

• Consent
• Compliance/Risk Assessment
• Fair Market Value & Tiering
• Engagement
• Meeting Services
• Transparency
• Transparency Outsourcing

Supported by technology, consulting services and managed services, these offerings share a reliance on IQVIA Connected Intelligence™, which combines industry-leading data, technology and domain expertise to help organizations surface useful insights and put them into action seamlessly.

The first guest presenter for this session was Allan T. Henriksen, Technical Lead (External), Global Healthcare Compliance at Leo Pharma A/S, is a multinational Danish pharmaceutical company founded in 1908 with a presence in about 100 countries. Allan spoke about his organization's journey as they implemented IQVIA Transparency Reporting (ITR). This intuitive software collects data from both automated and manual sources to help companies like Leo Pharma reduce cost by simplifying HCP and HCO spend aggregation, improving data validation and mitigating risk.

Allan explained how prior to April 2016, the organization was using a cumbersome, error-prone manual process in which spreadsheets were being sent between affiliates. At that point the company introduced an automated process, Leo STAR, but updates were cumbersome and long - it could easily take several weeks to test a new release. Leo rolled out ITR internally in August 2021, and today updates are tested within days. Local users in multiple countries maintain disclosure responsibility and knowledge of reporting requirements based on a quarterly snapshot from IQVIA and upload their "own" spend (paid by affiliate), while a central team uploads HQ spend, acts as super users, configure ITR have responsibility for HCP Master data. Benefits to Leo Pharma include:

Updates and upgrades are handled with a minimum of effort

New reports for covered markets/industries are easily available

Inclusion/Exclusion reports for an easier reconciliation

Better reporting capabilities

New and improved functionality coming on a regular basis

Allan was followed by Mathieu Flet, Global Head Transparency Reporting & ERC Products Portfolio Management, Novartis, who provided an overview of transparency reporting at that organization. One of the world's 10 largest pharma companies and with a focus on oncology products, Novartis articulates its mission as, "Build trust with society via transparency reporting", with a vision to timely address transparency reporting requirements, be equally transparent across countries, and support the business in taking more informed decisions. Transparency reporting at Novartis rests upon three strategic pillars:

Secure compliance obligations

• Transparency regulation updates & emerging transparency regulations

Improve operational excellence & optimize financial resources

• Increase automation & efficiency

Go beyond reporting obligations; further increase trust with society

• Transparency analytics, legitimate interest enforcement, HCP value cap implementation

Novartis has been collaborating on transparency reporting with IQVIA since 2012, when AGS 360 was implemented. AGS 360 is now in the process of being replaced by ITR, with pilots completed in Belgium, Estonia and Greece and Wave 1 onboarding now underway.

IQVIA's Rajesh Patel – Sr Dir of Product, HCP/O Engagement Management (Engage) and Daniel Spiteri – Sr Dir of Product, IQVIA Transparency Reporting (ITR) closed out the session with an overview of the Commercial Compliance organization and a presentation of the product roadmap process. Rajesh and Daniel articulated how IQVIA Product teams are responsible for delivering core product to be utilized in customer environments. Four groups of IQVIA stakeholders work together on the process:

• Product Owners determine product strategy, manage & prioritize feature enhancement backlog (client/internal) and plan product roadmaps
• Engineering assesses technologies to support product roadmap requirements and develop and test core product offering & orchestrate integrations
• Strategy defines product strategy across Commercial Compliance and other IQVIA & partner offerings, establishes strategic roadmap and organizes user groups & market research
• Product Support and Customer Success provide technical and product support by experts and deliver the level of knowledge required to satisfy user needs