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Day Two: Friday, 8 November, 2024 - CET (Central European Time, GMT+01:00)
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Day Two: Friday, 8 November, 2024 - CET (Central European Time, GMT+01:00)
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8:45am - 9:00am
Chairperson’s Review of Day One
9:00am - 9:30am
Sponsor Case Study—Transparently Confidential: A Framework for Protecting CCI
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
- Petra Evenäs, PhD - Director, Clinical Trial Disclosure & Transparency, Genmab A/S
9:30am - 10:15am
Strategies to Develop Enterprise-Wide Alignment and Systems-Level Approach to CCI Protection
- Discuss common barriers sponsors face in developing multi-stakeholder alignment in disclosure processes to ensure a systems-level approach to consistent protection of CCI
- Explore strategies to enhance enterprise-wide standardisation and alignment between departments/roles to ensure protection of CCI in the pre-approval stages (such as teams involved in informed consent and trial results summaries)
- Helen Ofoche - Clinical Trial Disclosure and Transparency, .
10:15am - 10:45am
Networking and Refreshment Break
10:45am - 11:30am
Breaking Down the Future of Data Sharing with EHDS Requirements
- 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
- Alexander Roussanov - Partner, Arnold & Porter Kaye Scholer LLP
11:30am - 12:15pm
Establishing Good Practices for Use of AI in PLS and Patient Communications
- 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
- Behtash Bahador, MS - Director, Health Literacy, Center for Information & Study on Clinical Research Participation (CISCRP)
- Zack Fey - Manager, Medical Writing, Center for Information & Study on Clinical Research Participation (CISCRP)
12:15pm - 1:15pm
Networking Luncheon
1:15pm - 1:45pm
Sponsor Case Study—Developing Effective Strategies In Preparing Pediatric and Adult Plan Language Trial Summaries
- 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
- Laurence Van Bree, PhD - Associate Director, Clinical Disclosure Office, Novartis
1:45pm - 2:30pm
Sponsor Panel—Overcoming Operational Challenges with Plain Language Summaries
- 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
- Jaclyn Spedaliere - Senior Director, Commercial Strategy & Delivery, Citeline
- Joe Carroll - Senior Manager, Clinical Transparency and Trial Disclosure, Regeneron
2:30pm - 3:15pm
Strategies to Build a More Accessible and Equitable Future for Plain Language Summaries
- Discover how to leverage innovative formats for more accessible plain language summaries (such as a video, graphics or webcast) 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, building culturally inclusive glossaries, and implementing this feedback to improve future writing
- Examine these key considerations and strategies in different therapeutic areas, including very complex cases such as oncology trials
3:15pm - 3:45pm
Updates on EU MDR Medical Device Disclosure Requirements For Companion Diagnostics/Drug-Device Combination Products
- Explore the unique disclosure regulatory requirements instated by the EU MDR and how this impacts disclosure processes for sponsors with companion diagnostics or drug-device combination products
- Discuss best practices in navigating EUDAMED submissions, including Clinical Investigation Data Summaries
3:45pm - 3:50pm
Close of Conference
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