14 November 2019, Clarion Copenhagen Airport

7th 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 2019:

How to survive an authority inspection – 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

Data Integrity and Computerised Systems – recent deficiencies in inspections

Finnish Medicines Agency

Mirka Laavola , Senior Pharmaceutical Inspector

Serialization in Norway – actual status from the Medicines Agency

Norwegian Medicines Agency

Line Saxegaard, Pharmaceutical inspector

Serialization – how we will inspect
– What to expect from the authorities regarding supervision of serialization

Swedish Medical Products Agency

Emil Schwan, Inspector GMP/GDP

Speaks with Emil Schwan

Swedish Medical Products Agency

Anna Beckman Gyllenstrand , Inspector

9 months after 9th of February- current status in Europe

– On-boarding to Eu Hub
– How to manage a “potential suspect falsification”
– Alert status & alert handling process

e-VIS

Kristina von Sydow, CEO

FMD Implementation – Best practices from AstraZeneca

13 sites around the world were involved in the process. 2000 articles were affected by FMD.

AstraZeneca

Anna Berg, QA Director, QP

FMD Implementation – Best practices from AstraZeneca

13 sites around the world were involved in the process. 2000 articles were affected by FMD.

AstraZeneca

Rikard Collin, Project Manager Supply Chain Projects

GDP/GMP – the most common deviations

Icelandic Medicines Agency

Jon Petur Gudmundsson, Inspector

FULLY BOOKED