Archives: Agenda

Discussing the status quo of clinical trials in Denmark and beyond including factors influencing country selection

• Considering barriers of success for site-set up and patient recruitment/screening
• Considering types of data that can be utilized to assist with patient recruitment challenges
• Incorporating data findings into development of eligibility criteria
• Using secondary health data to identify sites and patient cohorts

• Incorporating digitalization and new technologies into your clinical trials
• AI & collaborative platforms: improving communication and efficiency among stakeholders
• Success stories, transformative case studies and key takeaways

• 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