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Outsourcing in Clinical Trials DACH & Western Europe
DAY 1|24th November 2021
DAY 2|25th November 2021
8:45 am Chair’s opening remarks
9:00 am Keynote Talk: Post-COVID-19 in the new world: Keeping Momentum when it comes to the Adoption of New Working Patterns and New Technology
- Accelerating the Vaccine Development and Deployment – Learnings and lessons: getting to market quickly and efficiently
- Forced to adapt: quick learning from the industry: trial continuity, drugs to patient’s homes, data monitoring, use of E-consent etc.
- Exploring the future of collaboration with International Regulators – could this be significant push needed to move away from a very slow-moving industry?
- Exploring multi-stakeholder vision for future of clinical trials
Global Lead, Clinical Innovation & Partnership
9:30 am Session Reserved for Sponsor
10:00 am Innovation in Sponsor Oversight: Planning, Managing, Documentation, and Data - A Real Live Experience Report
- Innovative techniques for Inspection Readiness in Sponsor Oversight
- Integrating all stakeholders (Trial Management, Data Management and Statistics, and PV) into the oversight process
- Incorporating Oversight Process and Business Intelligence on Trial Data
Head of Clinical Data Management and eClinical Systems
10:30 am Session Reserved for Medidata
11:00 am Networking Break & Refreshments
11:30 am AI and Real-World Evidence (RWE) to Support Drug Development
As the landscape for RWE and AI continues to evolve, this session will look at the implications for current infrastructure, governance, operating models, people and processes of pharma companies.
- A case study look at the insights of market leaders who have developed end-to-end RWE program
- A delve into the future: How is the data landscape evolving and how will this impact on AI and RWE
12:00 pm Session Reserved for Within3
12:30 pm Expanding the Universe of Data Used in DACH & Western Europe to Inform Drug Develop
- Implementing best practices for protecting patient privacy when sharing data
- Applying the tools and techniques to better data sharing
- Facilitating data sharing to make it easier for sites by digitalising your study start-up process
- Working hand in hand with sponsors to keep up to speed with technology for data sharing
Review Editor on the Editorial Board of Blockchain for Science
1:00 pm Lunch & Networking Break
2:00 pm Session Reserved for Sudova
2:30 pm Updates on Current Regulatory Guidelines in the DACH & Western European Region and The Impact it has on Current Trial Activity
- Revising the current regulatory standards when conducting a clinical trial
- Understanding the differences between Swiss and EMEA standards
- Considering data collected from outside the DACH/EU region and ensuring it meets the standards in place
- Outlining regulatory processes for virtual trials
- What can we expect with future regulations and how we can best prepare
Global Program Leader& Head Of Clinical Operation
3:00 pm Strategy for Decentralized Trials from Different Stakeholders Perspectives
- Looking at how the strategy has evolved over the last 2 years, what have we learned?
- Understanding how ethic committees are dealing with the new informed consent
- Working with the right sponsors and services to ensure an efficient strategy
Director Health Informatics
3:30 pm Refreshments & Networking Break
4:00 pm LIVE PANEL DISCUSSION: Is the Pharma Industry Still too Conservative with Wearable Tech?
This session will give you 5 key takeaways for how and why you should incorporate wearables into your study.
- Discussing what wearable technologies are available and accepted by regulatory authorities
- Exploring home monitoring technologies to collect patient data in a timelier manner
- Overcoming challenges when shifting to wearables whilst ensuring patient safety
- Considering the infrastructure required for wearables when running a large multi-region trial
- How are wearables being more widely used to help with reimbursement?
Director Health Informatics
4:45 pm Identifying the Right CRO To Work with Before Starting Your Study
- Utilising early site strategies to get ahead of the competition
- Understand your studies needs and conditions to assist in narrowing down your search
- What resources from the CRO that are essential for your study success?
- Site screening: Analysing site’s past studies to get a better understanding of which site is right for you
Senior Director, Study Management
5:15 pm Close of Conference Day 1 & Drinks Reception
Clinical Operations & Outsourcing Stream
2:30 pm Session Reserved for Sponsor
3:00 pm Conclusion & Reflection Zone: Gather your Thoughts over the Past Two Days and Reflect on the Issues and Lessons Learned from your Peers
Topic 1: The ever-growing importance of remote monitoring of future trials
Topic 2: The implications of COVID-19: how prepared are we for next time?
The Outsourcing Clinical Trials programme is written in collaboration with industry, if you have a case study, idea or just a comment, please contact:
T: +44 (0) 2079366 607