21 November 2024

Clarion Copenhagen Airport

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12th 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.

Early bird offer - register before 24th of May

Speakers 21 november 2024:

Dicillin-recall case Part 2: Next steps from an authority perspective

– Impact on inspection practices

– Coming changes in guidance documents to prevent the issue to reoccur

– The most common deviations, 2021-2024

– Deviations/findings that surprised me

Danish Medicines Agency

Thomas Noe Vestergaard Pedersen, Medicines Inspector & Team Manager

To be announced

Icelandic Medicines Agency

Falsified Medicines Directive, Substandard Medicines and Quality Deficiencies.

– What is the difference between a falsified medicine and a quality deficiency?

– Can the EMVS be used to ensure quality in the entire supply chain?

– Could the system in addition to the initial purpose be used to simplify the supply chain and increase quality?

The European Medicinces Verification System (EMVS) has been up and running since 2019 when the FMD became effective. The digital development provides for more data available in the supply chain, which brings both challenges and opportunities.

Kristina von Sydow will share learnings and experiences from the Swedish national organisation, provide an update on current developments at the Nordic and European level, as well give a perspective on what could be seen in the future for the verification system.

e-VIS

Kristina von Sydow, CEO

The responsibility of MAH: requirements for GMP and GDP oversight

Swedish Medical Products Agency

Emil Schwan, Pharmaceutical inspector

Import of medicinal products into the EES – which transactions are acceptable and which are not?

Swedish Medical Products Agency

Peter Borgå, Pharmaceutical inspector

Inspections of wholesalers

– Inspections of wholesalers with common Nordic quality organizations

– The most common deviations, 2021-2024

– Deviations/findings that surprised me

Norwegian Medicines Agency

Eva Tollefsen, Pharmaceutical inspector

Common issues in supplier management in GMDP environment

Finnish Medicines Agency

Katja Belt, Senior Inspector

Chairperson of Nordic Qaforum

Anna Pontén-Engelhardt

Speaker to be announced in June

Hybrid event:

As a delegate you can decide if you wish to attend onsite at Clarion Copenhagen Airport or attend the live stream.

 

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

Venue:

Clarion Hotel Copenhagen Airport
Ellehammersvej 20, Copenhagen

Transport from Copenhagen Airport:
2 min walk through a covered
walk-way

Schedule 21 nov 2024:

08.30 Registretion & coffee
09.15 Conference starts
17.15 End of conference
17.15 Networking reception

Questions about Nordic Qaforum:

Please contact:
Niko Fastman, Project manager Nordic Qaforum
niko.fastman@kompetensinstitutet.se

Delegate fee

Standard price
Dkk7990
  • Lunch & refreshments
  • Networking reception evening before the conference
  • Networking reception right after the conference
  • Documentation
  • Certificate of participation

Attend onsite or online

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