12 November 2020, Clarion Copenhagen Airport

8th annual Nordic QAforum

The largest QA-conference in the Nordics.

5 national agencies

Get insights from the authorities from Sweden, Denmark, Iceland, Norway and Finland.

Case studies & discussions

Get best practices from your industry colleagues.

Speakers at Nordic Qaforum 2020:

21 months with 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?

e-VIS

Kristina von Sydow, CEO

How to survive an authority inspection 2021 – a practical guide

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

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

Speaks with Anna Beckman Gyllenstrand

Swedish Medical Products Agency

Mihai-Andrei Florescu, Inspector GMP/GDP

Annex 1 – How will it affect you

– Deviations & findings that surprised us

Finnish Medicines Agency

Mirka Laavola , Senior Pharmaceutical Inspector

GDP/GMP – the most common deviations

– Deviations & findings that surprised us

Icelandic Medicines Agency

Jon Petur Gudmundsson, Inspector

Early bird discount - register before 12th of june