Sponsor Oversight: Risk, Quality & Partnership
With ICH GCP E6(R3), sponsor oversight is under sharper focus – requiring proactive, risk-based, and transparent approaches. Join us to explore practical strategies for ensuring compliance, strengthening CRO partnerships, and safeguarding data integrity and patient safety.
Three Takeaways
- Gain insight into how evolving GCP R3 oversight impacts clinical trial compliance.
- Understand practical, risk-based strategies to strengthen quality and regulatory adherence.
- Learn how effective CRO and CDMO partnerships safeguard product quality and patient safety.
Speakers
- Berit Gorsøe Kjeldsen, Senior Project Manager, Clinical Operations, KLIFO.
- Birgitte Esmarck Meibom, Senior Project Manager, Clinical Operations KLIFO
About KLIFO
KLIFO is an integrated North European drug development consultancy with significant experience in partnering with pharmaceutical and biotech companies. At KLIFO, we offer end to end solutions across all drug development areas, including strategic project management, regulatory affairs, clinical development, clinical trial supply, quality assurance, Chemistry Manufacturing and Controls development, non-clinical development and pharmacovigilance concerning the development of pharmaceutical products.