Agenda Archive

Chairperson’s opening remarks

PANEL DISCUSSION The clinical trial landscape for small to mid-sized biopharma in the DACH region

• New regulations and guidance around clinical trials in the DACH region: how will this impact you?
• Staff turnover and layoffs: handling changes in the industry in order to ensure success
• Navigating the constantly evolving vendor and CRO landscape as a small to mid sized sponsor company
• An overview of technology and innovation in the clinical trial industry: what’s working and what isn’t?

VIRTUAL SESSION Exploring WHO’s new framework for strengthening of trial systems

Strengthening regulatory and ethical frameworks and ensuring trials follow global standards and Good Clinical Practice
Building capacity and infrastructure, training researchers and enhancing facilities for high-quality trial execution
Promoting data transparency and global collaboration, registering trials and sharing data to improve research outcomes
Streamlining approval processes, speeding up trial initiation for urgent health needs while maintaining safety and compliance

FIRESIDE CHAT Oversight management: Fostering a collaborative partnership between Sponsor and CRO

•Assessing overall project risk and appropriate surveillance tactics
•Ensuring that KPIs are informative and meaningful
•Documentation of Sponsor oversight activities throughout the study

FIRESIDE CHAT Exploring the benefit of integrative IT applications in clinical trials for small biopharma companies

Discuss the importance of the concept of a “single source of truth”
How can we improve Data integrity and Accuracy?
What can we do to strengthen Regulatory Compliance and Auditability in a scientific driven environment?

Building the bridge from pre-clinical to clinical studies: an overview of the regulatory landscape

Gaining a comprehensive overview of the regulatory landscape when transitioning from pre-clinical to clinical studies, focusing on the investigational medicinal product (IMP) nature and its implications for regulatory submissions
Key operational considerations, including navigating complex regulatory frameworks and meeting the requirements of the EU Clinical Trials Regulations, will be discussed
Exploring how advanced therapies, such as gene, cell, and tissue therapies, are reshaping regulatory strategies and driving innovation in the clinical trial process

Transforming clinical trials: the role of blockchain in revolutionizing clinical data management

Ensuring data integrity: how blockchain guarantees tamper-proof clinical records
Enhancing transparency and security in clinical trials through decentralized systems
Streamlining payment processes and contract management in clinical research with smart contracts
Real-world applications: leveraging blockchain for retrospective analyses and observational studies
The future of clinical data collection: operational efficiency and financial sustainability with blockchain

DRINKS RECEPTION

Navigating ICH GCP E6 (R3): updates and best practices

Understanding the changes in ICH GCP E6 (R3) vs ICH GCP E6 (R2) in a user-friendly manner·
Implementing effective compliance measures to ensure alignment with evolving regulatory expectations
Identifying key challenges and ways to overcome them