12 November 2020

8th 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.

We have emailed all the info about the Live Stream to all our delegates

Please email us for info: kundtjanst@kompetensinstitutet.se

Speakers at Nordic Qaforum 2020:

21 months with FMD – current status in Europe

– Alert management – real cases and investigations. What happens when the system identifies a potential falsification?

– Alert management around Europe. Similarities and differences. Could there be one alert management process for whole Europe?

– Change management for a pan-european system. How do you handle change management for one eco-system with 30 systems owners?

e-VIS

Kristina von Sydow, CEO

Q&A

– Ask your questions to Norwegian Medicines Agency

Norwegian Medicines Agency

Line Saxegaard, Pharmaceutical inspector

How to survive an authority inspection 2021 – 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

GxP Inspections during Covid19 pandemic – adapting to a new reality

Icelandic Medicines Agency

Hjalti Kristinsson, Head Of Drug Safety Division

Monitoring the quality of COVID-19 test kits with real-time visibility technology

Drawing from an actual example demonstrating how real-time monitoring has helped Ipsos MORI monitor location and quality conditions of tens of thousands COVID-19 test kits throughout the UK, attendees will take away a better understanding of and actionable insights into:

– How real-time visibility has helped ensure quality and mitigate supply chain risk
– How technology is automating the quality control and release process
– How stakeholder collaboration and data sharing is key to achieving supply chain resilience
– What the post-pandemic supply chain will look like

Ipsos MORI

Kelly Beaver, Managing Director

Speaks with Anna Beckman Gyllenstrand

Swedish Medical Products Agency

Mihai-Andrei Florescu, Inspector GMP/GDP

Inspections – what you can expect from us
– What to expect regarding supervision of serialization
– GDP/GMP – the most common deviations
– Deviations & findings that surprised us

Swedish Medical Products Agency

Anna Beckman Gyllenstrand, Inspector

Annex 1 – How will it affect you

– Deviations & findings that surprised us

Finnish Medicines Agency

Pirjo Hänninen, Senior Pharmaceutical Inspector

Speaks together with Kelly Beaver

Controlant

Ada Pálmadóttir, MPharm, MBA, Director of Pharmaceutical Validation and Compliance

Would you be interested in a live stream?

Please email us for info: kundtjanst@kompetensinstitutet.se