Module 1 2021

Working with Alliances/Partners/CRO

• There can be only one Sponsor of a US application – Need to clearly define and establish responsibilities of the respective parties and any transfer of Sponsor obligations • Contract Research Organization – A person/entity that assumes, as an independent contractor to the sponsor, one or more of the obligations of a Sponsor e.g., monitoring investigations – Any transfer of obligations must be described in writing and indicated in the application – The Sponsor holds the final/ultimate responsibility • Timely sharing of safety data is essential if clinical studies are ongoing in other countries / regions managed by the Partner

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Thank You

What are your questions

Contact info: Marga Oortgiesen Email: marga.oortgiesen@ucb.com

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