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

e-VIS

Kristina von Sydow, CEO

Q&A

– Ask your questions to Norwegian Medicines Agency

Norwegian Medicines Agency

Line Saxegaard, Pharmaceutical inspector

Development of a Covid vaccin – best practices and lessons learned

Valneva

Anna Pontén-Engelhardt, VP Quality

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).

Danish Medicines Agency

Thomas Noe Vestergaard Pedersen, Medicines Inspector & Team Manager

End to end quality management
– from development to commercialization

AstraZeneca

Anna Berg, Director Of Quality, Global Supplier Quality (GES) EMEA,

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.

RegSmart Life Sciences

Emil Schwan, Quality consultant, former inspector

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

Swedish Medical Products Agency

Anna Beckman Gyllenstrand, Inspector

Annex 1 – How will it affect you

– Deviations & findings that surprised us

Finnish Medicines Agency

Pirjo Hänninen, Senior Pharmaceutical Inspector

GxP Inspections during Covid19 pandemic – adapting to a new reality

Icelandic Medicines Agency

Hjalti Kristinsson, Head Of Drug Safety Division

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