Archives: Agenda

• Selecting the right dose in line with FDA guidance
• Sharing implementation methods within study designs and protocols
• Highlighting challenges and successes

Pharmacovigilance in clinical trials is a collective effort; however, for biotech and specialty pharma, limited resources and dynamic pipelines can make it more challenging to scale effectively. This session will provide a practical framework for defining roles, responsibilities, and oversight in PV, from sponsors and CROs to vendors and investigators. Attendees will learn how hybrid outsourcing models can provide flexibility and global coverage without overbuilding internal teams, and how strong partnerships transform PV from a compliance requirement into an enabler of trial success.

• Understand how pharmacovigilance roles and responsibilities align across sponsors, CROs, vendors, and investigators, and why clear roles prevent inefficiencies and issues
• Learn how biotech and specialty pharma can develop scalable pharmacovigilance strategies that adapt to dynamic pipelines
• Discover how hybrid outsourcing balances in-house oversight with external expertise for global coverage
• Explore methods to enhance partnerships so pharmacovigilance can support both compliance and operational delivery
• Recognize how a well-designed pharmacovigilance model can accelerate progress from early development to marketing approval

Consistent patient engagement is vital to clinical trial success, yet dropout and non-compliance remain persistent challenges. This session introduces gamification as a scientifically grounded strategy to boost retention, enhance adherence, and streamline trial execution.

·          Understand the Science: Explore the behavioral and psychological foundations that make gamification a powerful tool for sustaining patient motivation

·          See Real Results: Review real-world case studies where gamification significantly improved retention, compliance, and trial timelines

·          Apply Proven Methods: Learn practical strategies and best practices for integrating gamified elements into clinical trial protocols

Fast, furious or never-ending: case studies on accelerating or unexpectedly inflating Phase IB/II timelines and budgets. A site team perspective

• Integrating RWE into clinical trial design
• Using RWE to enhance or compliment traditional evidence generation
• Sharing successes and lessons learned

• The real cost of “free” software and the security gaps it creates
• How technical debt in open-source stacks becomes a growing risk for financial institutions
• Why traditional “shift left” approaches are no longer enough
• What a secure-by-default model looks like and what organisations should expect from their tools and teams

As financial services firms continue to digitise, their exposure now stretches far beyond the traditional perimeter. From the dark web to domain impersonation and unpatched vulnerabilities, risks can emerge anywhere your brand or data appear online.

This session explores how organisations can harness diverse intelligence sources – including the dark web – to uncover hidden risks and strengthen their digital resilience. Through real-world examples, we’ll show how Digital Risk Protection (DRP) turns threat data into clear, actionable insight that helps financial institutions stay ahead of attackers