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Outsourcing R&D and the marketing authorization – the GxP perspective

What are the specific regulatory requirements and considerations to subcontracted data when being assessed for marketing authorization of medicinal products?

When

19-03-2020 14:30 - 18:00

Location

Mærsk Tower, 15th floor
Blegdamsvej 3a
2100 - Copenhagen
Denmark

Organizer

Biopeople & ImmuMap ApS

Ever increasing proportions of research & development activities are conducted by contract-research-organizations (CROs) on behalf of biotech and pharma companies. However, what are the specific regulatory requirements and considerations to subcontracted data when being assessed for marketing authorization of medicinal products. This event sets out to provide a practical guide to industry on how to manage the interface between CROs and sponsors. Guidelines and regulatory considerations concerning the interface will be presented and discussed.

Programme

14:30 Registration opens

15:00 Welcome, Biopeople

  • Take the myths out of regulatory requirements of inspections and QMSs in the interface between CRO and sponsor! How are inspections of laboratory and analytical data managed, including analysis of human specimens? Lene Bjerring Bork, the Danish Medicines Agency

Short presentations from companies (will be updated)

Panel discussion and a light reception

17:30 Fare well

Join us for a great afternoon on top of the Mærsk Tower, with great talks, conversations and networking. We will serve a network reception to complete this network meeting. You are welcome!

It is free, but registration is mandatory here!

For further information, please contact: Per Spindler, Biopeople, pesp@biopeople.ku.dk

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