The EMA’s flagship Policy 70 is being reinstated. Clinical data submitted to the EMA for the purpose of regulatory approval will be proactively published. This starts with marketing authorization applications with new active substances. However, in 2024 this will apply to all types of applications. Throughout the next year major challenges such as protecting commercially confidential information and preventing re-identification of study participants are inevitable. Join this talk to leverage the expertise of one of the writers of policy 70 itself to set up your 2024 clinical submissions strategy in a way that will fully comply with policy 70. Insight into the dos and don’ts. Uncover 2024 and beyond.

Policy 70 originally launched in 2015 before being temporarily put on hold in 2018 while the EMA relocated from London to Amsterdam post Brexit. Then the pandemic struck. Up until now the only submissions that have had to follow policy 70 are those for COVID-19 treatments and vaccines. Therefore, the individuals who have the most experience with complying with policy 70 are those who worked on the submissions for these COVID-19 treatments and vaccines. Join this talk to uncover the challenges and breakthroughs Regeneron’s clinical trial transparency manager faced when engaging with policy 70. Uncover lessons learned and best practices from one of the industry’s best.

• Hear from the individuals submitting the clinical study reports of top performing pharma to CTIS everyday
• Start succeeding with CTIS as you soak up expert insight into how to overcome CTIS’s biggest challenges
• Evaluate the different strategies on how to adapt to CTIS and the new EU CTR directive for large clinical operations
• Become an expert at CTIS with a deep dive into the system with real examples, best practices and guidelines
• No more introductions or 101’s. Really learn how to overcome the biggest challenges and toughest obstacles when using CTIS

With major regulatory change across Europe and the development of a new EU clinical trials regulation directive it is time to shift corporate process and clinical strategy to meet the new era of regulation. With a deep dive into the strategy of a transparency and regulatory disclosure pro uncover a journey to effective EU CTR implementation to ensure continued compliance and clinical development.

• Understand the newest requirements set out by the new EU CTR
• Discuss the key challenges regarding clinical trial disclosure based on the experiences with EU CTR thus far.
• Obtain insight into the various strategies on how to handle clinical trial disclosure in CTIS.

• The biggest barrier for patients trying to access data is that not only do they not know where to find lay summaries, but they also are not as simple and informative as they should be
• Join in on an open collaboration between medical writers, patient advocates and yourselves to create truly patient centric documents to disclose.

Identifying and redacting Confidential Information in clinical documents while adhering to critical regulatory timelines has become a company-wide priority. This session will examine end-to-end processes including document structure and authoring processes, tracking proprietary information throughout the clinical lifecycle and ideas to optimize internal collaboration regarding CCI.

Ensuring commercially confidential information is not disclosed can be very tricky. There are different strategies and work structures that can alleviate the burden however there are very innovative technologies such as AI and machine learning that can rid all workload from the sponsor and automate the entire process with great accuracy. Hear from the most innovative vendor companies entering the market and partner up to protect your data, remain compliant and increase your competitiveness.

• Join in on an insightful discussion between industry experts who pick apart the interim guidance document provided by the European Medicines Agency on protecting personal data and commercially confidential information while using CTIS
• Hear from various experts and thought leaders in the field on how they are applying guidelines and taking further innovative steps to create their own best practices to remain fully compliant
• Get updated on what the industry leaders think are the best solutions out there to utilise including AI and machine learning
• Understand the importance of protecting personal data and commercially confidential information. Build your confidence in document curation and submission while ensuring your company’s information is kept concealed
• Level up your data disclosure know-how to help elevate clinical research while retaining compliance excellence