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 14th of June

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

European Shortages Monitoring Platform – how will it impact the industry

– What is the ESMP and how will it work?

– How will this new inititiave impact pharma industry and supply chain?

– When is the platform coming live and how can the industry start preparing? What parts of the company will it involve?

– Will the ESMP replace national initiatives? How can companies and national authorities interact around the ESMP?

– How can the ESMP be set up on time with the right quality?

– EFPIAs/MfE initiative to use EMVS (European Medicinces Verification System) in connection to the ESMP.

Véronique Davoust has over 20 years experience in the pharmaceutical industry, both in Regulatory Affairs and Manufacturing, for Pfizer Inc. In her current position she is responsible for the monitoring and analysis of global and European emerging regulations and guidelines that impact manufacturing sites, especially focussing on Good Manufacturing and Distribution Practices, security of the supply chain, product shortages, serialisation and registration of the Quality section of Marketing Authorization dossier throughout the product life cycle. Furthermore, she ensures the communication and implementation of the guidelines and regulations within the firm, as well as the coordination of responses to competent authorities.

She is deeply involved in Trade Associations activities (eg. European Federation of Pharmaceutical Industries and Associations (EFPIA) or the French LEEM), serving on leadership teams in quality or supply chain. She currently supports the development of EMA’s European Shortages Monitoring Platform (ESMP) as Efpia’s subject matter expert. Véronique is a pharmacist and earned a Doctorate in Pharmacy at the University of Rouen in Normandie, France, and is based in Paris.

Pfizer

Véronique Davoust, Global Supply Global Quality Operations, Regulatory Intelligence

Common issues in supplier management in GMDP environment

Finnish Medicines Agency

Katja Belt, Senior Inspector

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

Swedish Medical Products Agency

Peter Borgå, Pharmaceutical inspector

Chairperson of Nordic Qaforum

Anna Pontén-Engelhardt

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

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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