12 November 2020, Clarion Copenhagen Airport

8th annual Nordic QAforum

The largest QA-conference in the Nordics.

National agencies

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

Case studies & discussions

Get best practices from your industry colleagues.

Social distancing will be maintained at the Nordic Qaforum according to the rules and guidelines of the Danish Health Authority. The conference is organized in a large ballroom.

Would you be interested in a live stream?

Please email us for info: kundtjanst@kompetensinstitutet.se

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 by 18th of September

Would you be interested in a live stream?

Please email us for info: kundtjanst@kompetensinstitutet.se