Event info
Date:26 Jan
Time:9.00 - 10.00
Venue:Online
Contact person
Louise Fur Høier

Louise Fur Høier

Event Manager & PA to CEO

MVA Inspirational Webinar Series – Verify your study design with regulators, and manage and contract your clinical vendors efficiently

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

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Recording

Here you can watch a recording of the webinar.

Program

8:50Online platform opens for registering participants 
9:00Welcome
David Munis Zepernick, Head of Business Development and Public Affairs, Medicon Valley Alliance
9:05Brief 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
 Vendor Management – tools for effective oversight
Heike Schön, Lumis Life Science Consulting GmbH, Managing Director
 Smart contracting for better control and oversight
Myrthe P. Trompert, LL.M., Salvius Legal B.V., CEO, Dir. Legal Consultant
10:00End 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

 

 

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