SPARK Norway Educational Forum: Regulatory Compliance and Strategy

National law and European directives, regulations and guidelines regulate development of medicinal product and medical devices. A product's successful journey from research to market and eventually patients requires a well-designed regulatory strategy and several consultations with regulatory authorities.

The meeting is part of the SPARK Norway Forum Series 2: Quality, regulatory and IP – monthly open meetings organized by UiO:Life Science and SPARK Norway partners.

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1700: Welcome

Morten Egeberg, administrative leader UiO:Life Science and leader of SPARK Norway

1705: Regulatory framework in EU – scientific advice and approvals

Jan Petter Akselsen, The Norwegian Medicines Agency

1715: Classification – is my product a medicinal product?

Kristin Odlo Høye, The Norwegian Medicines Agency

1725: Non-clinical requirements for FIH clinical trials

Anne Soleng, The Norwegian Medicines Agency

1735: How to get approval before starting a clinical trial

Anette Solli Karlsen, The Norwegian Medicines Agency

1745: Regulatory framework for medical devices

Bjørn Kristian Berge, The Norwegian Medicines Agency

1755: Questions  

Ca. 1810: Meet the regulators

Sparkees will have the opportunity for F2F conversation with regulatory assessors.


About The Norwegian Medicines Agency, NoMA

The national competent authority in the area of medicinal products (drugs for human and veterinary use) and is the regulatory authority for medical device (not included CE-marking).

NoMA is fully integrated in and participates as other member states in the EU-regulatory network organised by The European Medicines Agency (EMA).


Published Dec. 11, 2018 9:41 PM - Last modified Mar. 11, 2019 12:15 PM