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


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


Kristina von Sydow, CEO

Serialization & Inspection

Norwegian Medicines Agency

Line Saxegaard, Pharmaceutical inspector

Development of a Covid vaccine – best practices and lessons learned


Anna Pontén-Engelhardt, VP Quality

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).

Danish Medicines Agency

Thomas Noe Vestergaard Pedersen, Medicines Inspector & Team Manager

End to end quality management
– from development to commercialization


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

Remote Inspections / Distant Assessments during pandemic and post pandemic

– Deviations & findings that surprised us

Finnish Medicines Agency

Siv Jantunen, Senior Pharmaceutical Inspector

GDP/GMP – the most common deviations

– Deviations & findings that surprised us

Icelandic Medicines Agency

Hjalti Kristinsson, Head Of Drug Safety Division

Hybrid event

As a delegate you can decide if you wish to attend on site at Clarion Copenhagen Airport or attend the live stream.

You can change between these two options anytime by informing us on kundtjanst@kompetensinstitutet.se

Attend onsite or online

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