Connecting Leaders To Improve Oversight and Collaboration
20 November, 2024 — Milan, Italy
Agenda
Wednesday, 20 November, 2024
9:00 a.m. – 10:00 p.m.
9 – 9:45 a.m.
Breakfast and Introduction
9:45 – 10:30 a.m.
Chiesi & Arithmos: Assessing the Impact of ICH E6(R3) on Clinical Operations
Hear a biopharma and Arithmos discuss the changes and implications of the new ICH E6(R3) guidelines. This includes during study conduct and post-study completion.
Francesca Vaccari
IPF & PAH Disease Area Clinical Operations Lead
Chiesi
Chiesi
Sergio Scaccabarozzi
Scientific Director
Arithmos
Arithmos
10:30 – 11:00 a.m.
Networking Break
11:00 a.m.– 11:45 p.m.
Debiopharm: Enabling CRO Collaboration in Sponsor eTMF
Debiopharm shares how they enable sponsor-CRO collaboration in their sponsor-owned eTMF system. They’ll explore best practices to align on expectations before and during study conduct, as well as improve oversight.
Evgenia Delyagina
Head of TMF Operations
Debiopharm International SA
Debiopharm International SA
11:45 – 1:15 p.m.
Networking Lunch
1:15 – 2:15 p.m.
Recordati: Improving Quality and Oversight for Outsourced Studies by Leveraging CTMS
Learn effective strategies to define and document oversight and how to leverage clinical systems to improve compliance from Recordati, a fast-growing biopharma.
Emma Forrest
Head of R&D Operations
Recordati
Recordati
2:15 – 2:45 p.m.
Networking Break
2:45 – 3:30 p.m.
Parexel: Streamlining Collaboration with Sponsors and CROs to Improve Oversight
Parexel shares how CROs can proactively support sponsors with study oversight, tips to improve data exchange between sponsors and CROs, and proven best practices to strengthen relationships between study partners.
Ed Fowler
Vice President, Operational Excellence
Parexel
Parexel
Pooja Purewal
Associate Project Director, Biotech
Parexel
Parexel
Christie Wilkins
Senior Director, Solution Enablement, Operational Excellence
Parexel
Parexel
3:30 – 4:00 p.m.
Coffee Break
4:00 – 4:45 p.m.
ITM: Improving Study-Specific Training Efficiency and Compliance
ITM Radiopharma shares their plans to improve study-specific training with Vault Study Training. This includes lessons to streamline implementation, automate training distribution, and improve compliance.
Elisabeth Coxon
VP, Head of Global Clinical Operations
ITM-Oncologics GmbH
ITM-Oncologics GmbH
4:45 – 5:30 p.m.
Esteve: Driving Clinical Transformation – Operating Model Considerations and Best Practices
What does it take to transform clinical operations? Esteve shares how to successfully undergo a transformation, strategies to balance vision with an evolving team, and techniques to ensure optimal oversight.
Jose Maria Gimenez Arnau
Chief Scientific & Medical Officer
ESTEVE
ESTEVE
Waseem Awad
Business Consulting
Veeva
Veeva
5:30 – 5:45 p.m.
Close
Evening Activities
5:45 – 10:00 p.m.
5:45 – 7:00 p.m.
Walking Tour in English (Optional)
8:00 – 10:00 p.m.
Networking Dinner (Optional)