Clinical Trials Development & Operations
This comprehensive track covers the latest advances in clinical research and operations. Sessions cover approaches to modernising design and conduct of clinical trials in the EU and beyond, advancing adoption and use of Complex Innovative Clinical Trials globally, with a particular focus on a patient and caregivers centred approach to clinical research. It will provide updates on key developments on Clinical Trials operations, the implementation of the EU Clinical Trial Regulation (CTR) implementation, data submission and transparency.
Who is This Track Designed For?
Professionals involved and/or interested in Clinical Trials Development & Operations. Regulatory Authorities, Regulatory Policy and Regulatory Affairs professionals, ethics Committees and HTAs, patients and healthcare professionals representatives, and other stakeholders involved in clinical research.
Topic Leaders
Mireille Muller
Regulatory Policy & Intelligence Director
Novartis Pharma AG, Switzerland
Mariane Lunzer
Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care
AGES, Austria
Key Topics
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Day 1: Tuesday, March 12th, Silver Hall
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Day 2: Wednesday, March 13th, Gold Hall
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Day 3: Thursday, March 14th, Copper Hall
DIA Europe 2023 Highlights
It will provide updates on key developments on the GCP Renovation (ICH E6, ICH E8), Clinical Trial Regulation, the Clinical Trial Information System, data submission, transparency, navigating ethical approval, study design in the digital age, innovative clinical trial designs (umbrella and platform trials, patient centricity), digital tools in development and other hot topics. It should be a must-attend for optimising development programmes and identifying cost savings through efficiency and innovation.