We invite you to join us for a breakfast meeting centered around the crucial topic of Sponsor oversight for clinical trials, that are partly or fully outsourced to a Contract Research Organizations (CROs). This meeting aims to explore and elucidate the best practices and strategies for ensuring effective oversight in such Sponsor-CRO collaborations.
As the landscape of clinical research evolves, the significance of robust Sponsor-CRO relationships cannot be overstated. With trials becoming increasingly complex and diverse, optimizing Sponsor oversight is paramount to adhering to GCP, and ensure a smooth collaboration and high quality data and documentation of the trial activities and outcomes.
During this meeting, we will delve into a comprehensive discussion on key facets of Sponsor oversight. Our expert speakers will spotlight proactive approaches to defining roles and responsibilities, and a pragmatic approach for planning and documenting sponsor oversight activities.
Your participation will contribute to an engaging exchange of ideas and experiences, shedding light on both challenges and successful Sponsor oversight tools for outsourced trial activities. Together, we can uncover innovative ways to navigate this dynamic landscape and elevate the standards of clinical trial Sponsor oversight.
Your participation will contribute to an engaging exchange of ideas and experiences, shedding light on both challenges and successful Sponsor oversight tools for outsourced trial activities. Together, we can uncover innovative ways to navigate this dynamic landscape and elevate the standards of clinical trial Sponsor oversight.
Join us for this interactive breakfast meeting, where collaboration and knowledge sharing will undoubtedly pave the way for optimized Sponsor oversight in an era of increasingly outsourced clinical trial activities.
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Date: Thursday 12th of October, 2023
Time: 8:30 – 11:00 CET
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Meeting room: Auditorium
Time: 8:30 – 11:00 CET
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Meeting room: Auditorium
Program
| 08:30 | Networking and registration |
| 09:00 | Welcome David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance |
| 09:05 | Introduction of speakers Izabela Adamczewska, Business Development, ProductLife Group |
| 09:10 | Best Practices & Considerations for CRO Oversight in Clinical Trials Birgitte Sloth, Chief Solutions Officer – Drug Development, Pharma IT Trine Stougaard, Principal Consultant – Clinical Science & Trial Operations, Pharma IT |
| 09:55 | Sparring and Discussion |
| 10:20 | Networking |
| 11:00 | End of Good Morning Meeting |
Speakers
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Birgitte Sloth, Chief Solutions Officer – Drug Development, Pharma IT VP of Clinical Operations and Principal Pharma Consultant with more than 13 years of experience with Clinical Science and Global Trial Management (Ph I-III) both as Clinical Scientist, Global Trial Manager, Clinical Project Manager and People lead. Experience with multiple different indications and solid experience with early phase clinical development, translational medicine and rare disease indication and regulatory strategy. |
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Trine Stougaard, Principal Consultant – Clinical Science & Trial Operations, Pharma IT Principal Pharma Consultant with 15 years of experience with the operational aspects of planning and conducting global clinical phase II-IV trials and non-interventional studies (from idea to publications incl. planning and conduct of Global Expert Panels). Extensive experience with outsourced clinical trials (from contracting to publications), CRO collaboration including CRO oversight, project management and stakeholder management. |
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