Thought leaders across ACRO member companies, including representatives to the ACRO European Regulatory Committee, recently traveled abroad to meet with both EU and UK regulators to advance better, smarter, and faster clinical trials in Europe.
On September 2, ACRO joined its first Bilateral Meeting with the European Medicines Agency (EMA) in Amsterdam. ACRO provided recommendations to shorten trial application timelines, foster alignment across regulations, and streamline the trial authorization process. Members also provided suggestions to enable a pragmatic, risk-based approach to AI in clinical research.
The following day, ACRO met with Medicines and Healthcare products Regulatory Agency (MHRA) leadership in London to share input on the new 2024 Regulation and Government and Agency initiatives to shorten both regulatory timelines and overall trial timelines – in addition to dedicated enhancements to areas such as scientific advice and Phase I trials.
Meeting with EU and UK regulatory authorities is an important part of the public policy process, and it impacts everything we do in our industry. We appreciate the receptiveness of both EMA and MHRA to ongoing dialogue with ACRO around issues impacting clinical trials and research.
Karen Noonan, Senior Vice President for Global Regulatory Policy at ACRO, was thrilled to join the following ACRO leaders participating in person at these meetings: Ari Feldman, Paul Bridges, Stephen Pyke, Leona Fitzgerald, Dinesh Mistry, Vesta Marciulioniene, Philip Hines, Chris Bamford, Zubin Thacker, Karl McEvoy, Jim Bush, Dave Simpson, and Vivienne Liddle Price. Many other members joined us remotely to share in the discussion as well.
The busy week concluded with a meeting of the ACRO European Regulatory Committee on Friday in London (Pictured Left to Right: Leona Fitzgerald, Jo Hulbert, Sarah Roberts, Helen Howitt, Sheuli Porkess, and Karen Noonan.)
For more information about ACRO’s efforts to advance industry interests in European legislation and regulation, visit: https://www.acrohealth.org/advocacy-hub/european-legislation-regulation/
ACRO would like to thank the following representatives and leaders in our industry for participating in these invaluable meetings with EU and UK regulatory bodies: