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.

Attend onsite or online

Speakers 2023:

The challenges for MAH

– European Medicines Agency reflection paper

– Being an MAH

AstraZeneca

Tor Gråberg, Head of Operations Quality Compliance and External Affairs

Drug shortages and guidelines for reporting to authorities

Icelandic Medicines Agency

Margrét Lilja Heiðarsdóttir, Expert in the Inspection and Supply Unit

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

Computerized systems in GDP-inspections, approach, challenges and experiences

Norwegian Medicines Agency

Eva Tollefsen, Pharmaceutical inspector

Recall case in Denmark and Iceland 2023

This talk will present a complex recall case in 2023, involving recall of pharmaceuticals in Denmark and Iceland.

Including following topics:

– Collaboration between EU authorities
– Handling the press
– Case evaluation in EMA-IWG and OMCL.

Danish Medicines Agency

Thomas Noe Vestergaard Pedersen, Medicines Inspector & Team Manager

How to survive a QC laboratory inspection

Swedish Medical Products Agency

Peter Borgå, Pharmaceutical Inspector

Chairperson of Nordic Qaforum

Valneva

Anna Pontén-Engelhardt, VP Quality

GDP – the most common findings

Finnish Medicines Agency

Minna Kurronen, Senior Inspector

Keeping on top of regulations – GDP

– Differences and similarities in the Good Distribution practices for Medicinal products for human use and Veterinary medicinal products

– What are the most important requirements to focus on in 2023/2024?

– How does the changes impact YOU as Wholesaler or Responsible Person?

AstraZeneca

Anna Berg, Head of Operational Excellence & QMS, External Quality

Annex 1 – How do we stay compliant?

– Practical experiences from implementation of EU-GMP Annex 1 at a manufacturing site

NorthX Biologics

Karolina Nordin, Head of Quality Assurance, QP

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 23 nov 2023:

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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