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

e-VIS

Kristina von Sydow, CEO

Serialization & Inspection

Norwegian Medicines Agency

Line Saxegaard, Pharmaceutical inspector

Development of a Covid vaccine – best practices and lessons learned

Valneva

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

Supplier quality oversight in external supply

AstraZeneca

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

Remote Inspections / Distant Assessments during pandemic and post pandemic

– Deviations & findings that surprised us

Finnish Medicines Agency

Siv Jantunen, Senior Pharmaceutical Inspector

Topic to be confirmed

Swedish Medical Products Agency

GDP/GMP – the most common deviations

– Deviations & findings that surprised us

Icelandic Medicines Agency

Hjalti Kristinsson, Manager/inspector, GxP inspections and supply

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 switch between these two options by informing us: kundtjanst@kompetensinstitutet.se

Attend onsite or online

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