18 November 2021, Clarion Copenhagen Airport
8th annual Nordic QAforum
The largest QA-conference in the Nordics.
National agencies
Get insights from the authorities from Sweden, Iceland, Denmark, Norway and Finland.
Case studies & discussions
Get best practices from your industry colleagues.
Attend onsite or online
Speakers:
FMD – current status in Europe
– Alert management – real cases and investigations. What happens when the system identifies a potential falsification?
– Latest news: European alert management guidelines & the alert Management system
– Covid-19 vaccines and alerts
Serialization & Inspection
Development of a Covid vaccine – best practices and lessons learned
Control of IT-systems – from an authority perspective
Before joining Danish Medicines Agency in 2013, Thomas worked for 12 years as a manager/director at the Danish pharmaceutical company Statens Serum Institute (now AJ Vaccines).
End to end quality management
– from development to commercialization
Speaks together with Anna Berg
Emil was previously an inspector at the Swedish Medical Products Agency between 2012 and 2020. He has carried out more than 200 inspections in several different countries.
Inspections – what you can expect from us
– What to expect regarding supervision of serialization
– GDP/GMP – the most common deviations
– Deviations & findings that surprised us
Remote Inspections / Distant Assessments during pandemic and post pandemic
– Deviations & findings that surprised us
GDP/GMP – the most common deviations
– Deviations & findings that surprised us
Hybrid event
As a delegate you can decide if you wish to attend on site at Clarion Copenhagen Airport or attend the live stream.
