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.
Speakers:
FMD – current status in Europe
– Alert management – real cases and investigations. What happens when the system identifies a potential falsification?
– Alert management around Europe. Similarities and differences. Could there be one alert management process for whole Europe?
– Change management for a pan-european system. How do you handle change management for one eco-system with 30 systems owners?
– Covid-19 vaccines and alerts
Q&A
– Ask your questions to Norwegian Medicines Agency
Development of a Covid vaccin – best practices and lessons learned
Control of IT-systems – from a 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
Annex 1 – How will it affect you
– Deviations & findings that surprised us
GxP Inspections during Covid19 pandemic – adapting to a new reality
