Marketing authorisation of medicinal products & regulatory requirements
Biopeople and ImmuMap host this event on top of the Mærsk Tower, where you have great talks, conversations and networking and learn about the myths and reality of regulatory requirements of inspections and QMSs in the interface between CRO and sponsor!
Ever increasing proportions of research & development activities are conducted by contract-research-organisations (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 authorisation of medicinal products.
Key note speakers include Lene Bjerring Bork, the Danish Medicines Agency, Denmark and Chris Rothwell, Covance, United Kingdom.
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.
A reception will complete this network meeting.