Archives: Agenda

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss 0ut!

• Exploring the meaning of risk sharing across roles
• Supporting balance between procurement and R&D priorities
• Strengthening partnership models through transparency

Moderator Rosie Filling, Vice President, Senior Global Head R&D Operations, Keenova Therapeutics

• Understanding why traditional recruitment approaches are no longer delivering consistent enrollment
• Recognizing the impact of trust, awareness, and misinformation on patient participation
• Sharing practical adjustments sponsors and sites are making to recruit more effectively

• Interpreting what has materially changed under ICH E6(R3), including governance, risk-based quality management, and sponsor oversight expectations
• Sharing how companies are operationalizing the updated guidance six months in—what has actually changed in trial design, conduct, and oversight
• Identifying common implementation challenges, grey areas, and lessons learned when aligning internal processes, CRO partnerships, and inspection readiness

Moderator Rosie Filling, Vice President, Senior Global Head R&D Operations, Keenova Therapeutics

• How historical male-centric assumptions shaped clinical research — and how this affected evidence generation, safety signals, and patient outcomes
• What has changed in prioritizing sex and gender today — including regulatory focus, better data capture, and new enabling tools
• How sex differences appear across the research lifecycle — using real-world case studies to show impacts on trial interpretation and success
• Why this is a pivotal moment for clinical research — with sex-aware data driving better insights, outcomes, and more representative evidence

During the roundtable discussion session, the conference hall will be divided into four ‘zones’. Delegates can choose which zone they would like to join. Each zone will focus on a different challenge within clinical operations.

ROUNDTABLE 1: Outsourcing and vendor models that fit today’s trials

ROUNDTABLE 2: Strengthening sponsor–site relationships in 2026

ROUNDTABLE 3: Making digital tools work for real teams

ROUNDTABLE 4: Fixing the hidden bottlenecks in study start-up