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

This event has been postponed due to the emerging situation of coronavirus/COVID-19 – new date will be announced at www.biopeople.eu

This event has been postponed due to the emerging situation of coronavirus/COVID-19 – new date will be announced at www.biopeople.eu

Join us for this CRO relevant workshop - What are the specific regulatory requirements and considerations to subcontracted data when being assessed for marketing authorisation of medicinal products?

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, ImmuMap & Biopeople

Lene Bjerring Bork, the Danish Medicines Agency, Denmark

• 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?

Chris Rothwell, Covance, United Kingdom

• Company perspective

[The speakers list is currently being 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 host a reception to complete this network meeting.

Everybody is welcome! Participation is free of charge, but registration is mandatory, please sign up here!

For further information, please contact: Per Spindler, Biopeople and/or Houman Pourhassan, ImmuMap, at hp@immumap.com

Downloads

20200319_GxP_Inspections_v10.pdf