Event Categories: DIA

Risk-based thinking is the key to focusing sponsor resources on the sites that need the most attention. Determining which sites those are and how to best address the risks they present requires advanced digital solutions, including artificial intelligence (AI) and machine learning (ML).

This conference will focus on the differences between the present and new requirements for managing clinical trials in the face of forthcoming changes, including the new EU clinical trials Regulation but also conducting novel complex innovative design trials. Regulators and other decision-makers, together with various experts in the field, will debate how the new legislation will impact the processes for the design, submission and approval, and managing European clinical trials in the future.

This conference will focus on the differences between the present and new requirements for managing clinical trials in the face of forthcoming changes, including the new EU clinical trials Regulation but also conducting novel complex innovative design trials. Regulators and other decision-makers, together with various experts in the field, will debate how the new legislation will impact the processes for the design, submission and approval, and managing European clinical trials in the future.

Featured topics
• Status of the CTR
• Ethics Committee preparedness for CTR
• Update on national pilots from MS
• Innovative Trial Designs and their Management
• GDPR and its consequences for Clinical Trials
• Member States preparedness for the regulation, including plans for co-operation between agencies and ethics committees and coordinated assessment
• Considerations for the preparation of applications and notifications by sponsors

The 2020 Conference builds on prior very successful conference series and leverages learnings from Regulators and international experts in the field. Clinical trial sponsors and academia are facing a host of new registration requirements in the EU, USA, and elsewhere. With evolving requirements comes new challenges, creating additional opportunities for knowledge-sharing and necessitating more interaction with peers. This event will provide essentials and timely information about global clinical trial disclosure and data transparency. It brings leading study sponsors from Industry and Academia to exchange knowledge and share their experiences with the implementation of Clinical Trial and Data Transparency from an academic and an industry viewpoint.

Digital technology is transforming the drug development process. The rise of wearable and mobile technologies along with cloud technology, Artificial Intelligence and related platforms, now enable the collection of frequent, specific, and multidimensional data throughout the length of trials. These technologies have the potential to enable innovative trial designs, improve the patient experience, act as recruitment and retention tools, and establish novel end points in clinical studies. With these technologies, large amounts of data are collected. How to best address evaluating fit-for-purpose, standardization, ethical concerns, and regulatory approaches, are key issues to address in the digital era. DIA’s Digital Technology in Clinical Trials Conference will bring together thought leaders from regulatory agencies, biotech, pharma, patients, and academia to discuss the latest advances, challenges, and forward-thinking approaches for implementing digital technology to improve clinical trials. While the conference will focus on the impact of digitalization in clinical trials today, we will make time to explore future applications and how they may enable the clinical trials of tomorrow.