Outsourcing R&D and the marketing authorisation – the GxP perspective
19-03-2020 14:30 - 18:00
Mærsk Tower, 15th floor
2100 - Copenhagen
Biopeople & ImmuMap ApS
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.
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.
For further information, please contact: Per Spindler, Biopeople and/or Houman Pourhassan, ImmuMap, at firstname.lastname@example.org