Archives: Agenda

• Building an organization with capabilities to reach an NDA-approval
• Transitioning from development to registration phase – what does it take?
• The importance of vendor governance and collaboration
• Preparing for next steps
• Key challenges and mitigations

• Selecting a CRO in Japan
• Discussing PMDA negotiations, regulatory landscape and inspection readiness
• Sharing challenges and benefits of conducting trials in Japan
• Overcoming initial doubts and providing lessons learned from partnerships between sponsor and CRO in Japan

• Building quality from day one: approaching Phase 1 as a small pharmaceutical company
• Challenges and overcoming resistance: exploring the initial obstacles faced in implementing the QMS and strategies for addressing organizational and cultural resistance
• Turning points and engagement: understanding of people and the organisation, fostering emotional investment, simplifying processes, aligning with business goals, driving changes and ownership
• Success and continuous improvement: discussing positive outcomes, management commitment, behaviour changes and the ongoing journey of evolving the QMS and quality culture

• European clinical research landscape
• Challenges and solutions
• Key success factor – the right country mix

During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

Roundtable 1
Progressing your planning as a small biotech whilst in funding mode
Judi Simonsen, CEO and Co-Founder, MERODZ

Roundtable 2
Selecting and managing sites: key considerations
Catharina Östberg, Head of Site Management Nordics, Bayer

Roundtable 3
Considering sustainability throughout the clinical supply chain: where can we improve?
Kamal Amin, Head of Supply Chain Management, Galderma

Roundtable 4
Integrating AI into clinical operations
Pietro Belligoli, Researcher, Former Roche

• Incorporating digitalization and new technologies into your clinical trials
• Collaborative platforms: improving communication and efficiency among stakeholders
• Success stories, transformative cases and key takeaways

• Ensuring temperature maintenance throughout packing, shipping and at sites
• Considering monitoring tools and loggers to assist in temperature tracking
• Complying with regulatory auditing guidelines
• Discussing trial product quality once it reaches the patient: who should be responsible?

From a patient advocate perspective, Merete will discuss the why, what, when and how of patient engagement