14 November 2018, Clarion Hotel Copenhagen Airport

6th 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 2018:

Delegated Regulation 161/2016 soon in force – are we ready?
– Obligations for different stakeholders
– Functionality of the national systems and the EU Hub
– Implementation – who is doing what?
– What can we learn from the pilots?
Anci Kvarnström

Project leader for the Swedish Implementation & Consultant for EFPIA

TOPIC TO BE ANNOUNCED

Finnish Medicines Agency

Johanna Linnolahti, Senior 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

International Inspections Lessons Learned
– How to convert audit learnings into robust and sustainable knowledge
– How can we improve our way of working

Before joining AstraZeneca in 2015 Tor Gråberg worked 11 years as the Chief Pharmaceutical Inspector at MPA (Läkemedelsverket).

AstraZeneca

Tor Gråberg, Head of Operations Quality Compliance and External Affairs

GDP/GMP – Which are the most common deviations?

Norwegian Medicines Agency

Line Saxegaard, Pharmaceutical inspector

Current GMP and Regulatory updates
– how will the updates effect you
– a regulators advice to ensuring compliance

Danish Medicines Agency

Kristine Frederiksen, Medicines Inspector

100+ delegates registered