Medicon Valley Alliance and Lumis Life Science Consulting GmbH are pleased to invite you to an online Good Morning Meeting on the 26th of January 2023, focusing on the optimization of scientific clinical plans, clinical vendor management and contracting. With rapidly changing standards of care, the appropriate clinical study design can be a moving target. Another key to success of clinical studies is smart contracting and efficiently managing the clinical vendors. How to make sure that the study design fits with regulator’s expectations and your own company strategy. How to ensure that the clinical vendors conduct your clinical trial in a best-practice manner?
Topics will include:
- Why, when and how to seek Scientific Advice with national or European authorities
- Target Product Profile as a tool to communicate with regulators
- Tools which can be used to optimize and maintain a successful CRO/vendor Management
- Early indicators for potential failure of a clinical trial and how to mitigate
- Smart contracting as a tool for control and oversight
- Contracts as a basis for constructive collaboration
Date: Thursday, January 26th, 2023
Time: 9:00 – 10:00 CET
Venue: Online
Recording
Here you can watch a recording of the webinar.
Program
8:50 | Online platform opens for registering participants |
9:00 | Welcome David Munis Zepernick, Head of Business Development and Public Affairs, Medicon Valley Alliance |
9:05 | Brief introduction of LumisConsult and Salvius Legal Heike Schön, Lumis Life Science Consulting GmbH, Managing Director |
Get regulator’s advice on your study design Dr. Christiane Juhls, Lumis Life Science Consulting GmbH, Project Director |
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Vendor Management – tools for effective oversight Heike Schön, Lumis Life Science Consulting GmbH, Managing Director |
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Smart contracting for better control and oversight Myrthe P. Trompert, LL.M., Salvius Legal B.V., CEO, Dir. Legal Consultant |
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10:00 | End of webinar |
Speakers
Heike Schön Managing Director Lumis Life Science Consulting GmbH |
Myrthe P. Trompert LL.M., CEO, Dir. Legal Consultant Salvius Legal B.V |
Dr. Christiane Juhls Project Director Lumis Life Science Consulting GmbH |
Organised by | In collaboration with |