Entering the Finnish Pharmaceutical Market
We advised an orphan drug company with the legal aspects relating to entering the Finnish market.
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Pharmaceutical Pricing
We regularly advise clients before the Pharmaceutical Pricing Board in complex pricing matters and assist with the drafting
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Clinical Trials
We have advised several clients regarding the drafting of all necessary documentation relating to Clinical Trials to be
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Biosimilars
We regularly advise clients in matters, which regard pricing and administrative issues relating to competing biosimilars entering the
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Risk Sharing Agreements
We have assisted several multinational pharmaceutical companies in their negotiations on Risk Sharing Agreements with the Pharmaceutical Pricing
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Reform of the Act on the Secondary Use of Social and Health Data
The Act on the Secondary Use of Social and Health Data (552/2019) is being reformed The Act on
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Government proposal regarding the implementation of EU’s NIS 2 Directive published
On 23 May 2024, the Finnish Government submitted its proposal regarding the implementation of EU’s NIS 2 Directive
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The EU’s Pharmaceutical Legislation Reform
The European Union’s imminent pharmaceutical legislation reform aims to modernise its regulatory framework, focusing on improving patient access
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The European Parliament and the Council reach an agreement on European Health Data Space!
Towards a stronger European Health Union On March 15, 2024, the European Parliament and the Belgian Presidency of
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Ready or Not, Here Comes the AI Act!
D&I’s summary of the changes coming your way The European Parliament has approved the Artificial Intelligence Act on