17 November 2016, Hilton Copenhagen Airport

4th annual Nordic QAforum

The largest QA-conference in the Nordics.

5 national agencies

Get insights from the authorities from Sweden, Denmark, Norway, Finland & Iceland.

Case studies & discussions

Get best practices from your industry colleagues.

Speakers:

Practical implementation of the Falsified Medicines Directive and Delegated Regulation
– Obligations for different stakeholders
– Functionality of the national systems and the EU Hub
– Implementation – who is doing what?
Anci Kvarnström

Project leader for the Swedish Implementation & Consultant for EFPIA

Topic to be announced shortly

Finnish Medicines Agency

Anne Junttonen, Chief Inspector

Continued Process Verification – Developing a Monitoring Strategy and Maintaining a State of Control

ÅF

Ann Weidensjö, Senior Quality & Validation Lead Consultant

The bumpy road of Serialization – an ongoing travel

Experiences and lessons learned from a small international company dedicated to rare diseases, on the road to fulfill the Serialization requirements in “All” markets, providing small series of each product and on top of that with all production outsourced to different CMO’s.

A presentation to share the knowledge we have gained on the way.

Swedish Orphan Biovitrum

Eva Hanö, Project Manager

Annex 16 – How will the updates effect you?

Swedish Medical Products Agency

Javad Mohammadnejad, Inspector GMP/GDP

Transport validation – what are the minimal demands on temperature validation
– Audit of your supply chain suppliers – when is it necessary and how to do it?
– Authority exemples from audits

Norwegian Medicines Agency

Bjørg Abotnes, Pharmaceutical inspector

Continued Process Verification – Developing a Monitoring Strategy and Maintaining a State of Control

ÅF

Anna Sumic, Consultant

The bumpy road of Serialization – an ongoing travel

Experiences and lessons learned from a small international company dedicated to rare diseases, on the road to fulfill the Serialization requirements in “All” markets, providing small series of each product and on top of that with all production outsourced to different CMO’s.

A presentation to share the knowledge we have gained on the way.

Swedish Orphan Biovitrum

Ginger Nikolaev, Project Manager

How we expect pharmaceutical manufacturers and wholesale distributors to work to prevent and detect fraud – both proactive and reactive in production and distribution

Icelandic Medicines Agency

Sigridur Ólafsdóttir, Head of Inspection

Current GMP & Regulatory updates
– A Regulator’s Advice to Ensuring Compliance

Danish Health & Medicines Authority

Claus Mortensen, Inspector

Dataintegrity
– How to identify & define an Electronic Record?
– How to create value during your contemporary effort to identify,
plan and implement changes to ensure the requirements of Data
Integrity?
– Examples of established technical solutions for regulated areas in
Supply Chain – Production, Laboratory (QC).

PlantVision

Lina Stange, Senior consultant

Embracing best practice to exceed customer expectations: yesterday, today and tomorrow

Recipharm

Staffan Widegren, Director of Corporate Projects

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