Day Two: Friday, 8 November, 2024Friday, 8 November 2024 - CET (Central European Time, GMT+01:00)

Hear a case study from an international biotech sponsor company:

• Detailing the process of developing a framework to secure confidential information from the ground up
• Discussing methods used to effectively convey to stakeholders the importance of smart CCI protection strategies

• Examine the patient perspective on sharing health data especially related to clinical trials data, including perspectives on the broader implications of data ownership and utilization in clinical trials and drug development
• Discuss how compliance and the culture in the pharma industry can clash with the patients’ needs and motivation, and explore the beneficial effects of new patient-centric approach to learn how the industry can foster a more equitable and patient-focused approach to data sharing and clinical data transparency

• Discover strategies for determining the optimal privacy model and data anonymisation approach for clinical data
• Discuss the governance decisions that are relevant in choosing the right privacy model in the pharmaceutical and medical device spaces, and how to strike the right balance between privacy and useful data

• Explore the impact of the impending European Health Data Space (EHDS) legislation and key considerations life sciences companies need to know to effectively prepare, in terms of both leveraging the access to a wealth of RWE and becoming data holders with access/disclosure obligations
• Analyse the aftereffects of EHDS on topics such as protection of CCI, GDPR compliance, data anonymisation, and internal data infrastructure and processes, and examine the impacts on different therapeutic areas

• Examine survey results from 1,000+ patient and public respondents in the EU & US on familiarity, trust, and comfortability toward AI use in creating plain language clinical trial documents
• Hear from representatives of a multi-stakeholder working group creating a good practice guideline document on use of AI in creating plain language trial communications
• Evaluate how to incorporate these insights and good practices into document creation processes

• Hear a sponsor case study exploring key considerations in preparing pediatric and adult plain language trial summaries, including what information is necessary to collect, strategies implemented to ensure alignment with technical results, and different templates used based on age categories
• Discuss developing effective processes for conducting PLS kick-off meetings, presenting metrics, and presenting secondary outcome measures

• Benchmark on current critical challenges sponsors are facing in the PLS space, and discuss key related concerns such as the downstream effect on informed consent and the patient experience
• Brainstorm strategies to optimise PLS procedures by streamlining operations and identifying key touchpoints throughout the process to ensure the creation of informative and effective PLS

• Discover how to leverage innovative formats for more accessible plain language summaries (such as standalone publications, videos, graphics or podcasts) that improve patient understanding to support better informed consent
• Discuss additional strategies to increase health equity in PLS, including incorporating feedback from diverse groups of patients and how to implement this feedback to improve future writing, as well as translating plain language material into different languages
• Examine key considerations and strategies for increasing awareness and discoverability of PLS for patient audiences