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Peer to peer discussion: Transforming the safety, regulatory and quality experience
Dec 23, 2022
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At the afternoon breakout session of TechIQ Europe 2022 dedicated to Safety, Regulatory and Compliance, IQVIA's Dario Ghoddousi, Senior Director - Commercial Compliance & Quality Solutions, EMEA introduced VP Joe Rymsza to kick off the roundtable session. Joe set the stage by explaining how SRQ is the fourth strategic pillar of IQVIA, which complements clinical trial design, real-world evidence, and commercial and technology solution pillars by providing AI-powered safety, regulatory and quality tech solutions combined with best-in-class consulting and operational services.

Joe described a life sciences operating environment of rapidly increasing complexity, in which challenges include:

  • 150% increase in regulatory mandates
  • 25,000 new regulations/year
  • New or changed regulation somewhere in the world every 25 minutes
  • 100% Growth in Adverse Events and Product Technical Complaints during 2021 vs. 20% historically
  • $200M spent by medical device companies on remediating compliance/quality issues (WSJ)

To meet them, IQVIA has deployed a technology strategy that relies upon intelligence-driven simplification and automation within and across SRQ. IQVIA Connected Intelligence™ combines industry-leading data, advanced analytics, and domain expertise to surface meaningful insights and put them into action when and where they can be most effective. In the SRQ space, it enables Regulatory Intelligence, in which integrated solutions provide a complete, connected SRQ ecosystem.

David Cousins, Senior Vice President, Healthcare and Life Sciences, Salesforce and Scott Fonseca, Global Head of Sales, SRQ, IQVIA continued the discussion with an in-depth exploration of the ways Connected Intelligence is enabling a re-imagination of compliance employing a new, holistic vision. IQVIA goes beyond simply optimizing individual safety, regulatory, quality, and compliance functions. Using cloud-based technology combined with advanced analytics on an integrated platform – including artificial intelligence and machine learning – IQVIA is bringing together global regulatory intelligence, safety data, product quality information, and legal/ethical guidance. For customers, this means:

  • Improved compliance performance at lower cost across all functions
  • Visibility across their complete compliance landscape
  • Faster response times
  • More predictive planning, throughout the product lifecycle

Connected Intelligence is driving simplification, automation and integration of SRQ processes and systems for life sciences companies. Many sectors – software, transportation, manufacturing – are now capitalizing on the advantages of automation. In life sciences, David and Scott identified specific drivers of compliance automation, including:

  • Cost control
  • Increasing regulatory changes
  • Increasing data volumes

At the same time, recent studies have identified specific challenges for the sector. In a recent Deloitte survey on AI1, life sciences respondents said their biggest hurdles by category were:

  • Organizational: Difficulty identifying the highest value use cases
  • Technology: Data challenges
  • Operational: Integrating AI into the organization

Seen through the lens of compliance, life sciences organizations seeking to automate compliance processes will need to address:

  • Defining short- and long-term business targets
  • Choosing the correct automation use cases
  • Legacy validation practices

The final roundtable presentation was hosted by IVIA's Scott Fonseca Global Head of Sales, SRQ, and Senior Principal Jens-Olaf Vanggaard. The team delved into the SRQ platform by explaining how integration drives efficiency and effectiveness by combining SRQ assets and leveraging similar functions and workflows. As with other IQVIA technology solutions, SRQ solutions are designed to be modular and interoperable, so clients can integrate them easily into an existing ecosystem.

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