Quality Working Party’s Pre-Workshop: Driving Quality and Compliance in a Changing Clinical Research World

11 & 12 May 2026 | Brussels | Hybrid Conference

In recent years, the clinical research environment has been shaped by significant regulatory, ethical, and technological change. Updates such as ICH E6(R3), evolving expectations around risk management and quality oversight, and the growing use of digital tools and artificial intelligence are redefining how clinical trials are designed, conducted, and supervised. While these developments aim to strengthen participant protection and data integrity, they also introduce new complexity for sponsors, investigators, auditors, and regulators alike.

The Quality Working Party Workshop provides a dedicated forum to explore these changes from a practical, cross-stakeholder perspective. Through open discussion and expert-led sessions, the workshop focuses on how new requirements can be implemented in a risk-proportionate and effective way, how inspection and oversight practices are evolving post-COVID, and how emerging ethical and technological challenges can be addressed without compromising quality or trust.

By creating space for open exchange and shared learning, the QWP Workshop aims to support consistent interpretation, pragmatic implementation, and continuous improvement in clinical research quality systems, laying the groundwork for more efficient, ethical, and sustainable trials in Europe and beyond.

EFGCP Conference 2026: Uniting for Success: A Multi-stakeholder Vision for Ethical Review in Europe

12 & 13 May 2026 | Brussels | Hybrid Conference -

Europe is at a defining moment for clinical research. The Clinical Trials Regulation set out a powerful vision: a continent united by transparency, collaboration, and efficient access to innovation. While its implementation brought both progress and pressure, it confirmed something essential—Europe’s commitment to ethics, quality, and patient protection remains unwavering.

National ethical review is a vital strength of Europe’s clinical research landscape. Ethics committees play a key role in ensuring trials uphold human dignity, scientific integrity, and public trust. Their contribution, together with the regulatory authorities' risk-benefit review, forms the foundation of a credible and high‑quality research ecosystem. By further strengthening the collaborative partnership, Europe can achieve an ethical review process that is both protective and efficiently aligned with the needs of modern clinical research.

Today, national ethical review stands at the centre of the conference discussion. Ethics committees face growing complexity; sponsors navigate longer reviews and more information requests. These challenges highlight not failure, but opportunity: the chance to rethink how Europe aligns ethical excellence with operational efficiency.

In addition, the European Commission’s proposed new Biotech Act offers a fresh pathway—clearer roles, streamlined processes, and modern ethical standards grounded in the 2024 Declaration of Helsinki. It invites us to shape a system worthy of Europe’s innovation leadership ambitions.

The EFGCP Conference 2026 is where this work begins. Here, stakeholders from across Europe come together to share best practice experiences, challenge assumptions, and co‑create practical solutions to optimise the system. Our goal is simple and ambitious: to strengthen participant protection while enabling efficient, faster, more predictable clinical trial authorisations and start up times.

Together, we have the opportunity to build an ethical review model that reflects Europe at its best—responsible, collaborative, transparent and ready to lead the next chapter of global research.