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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Programme
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1700: Welcome Morten Egeberg, administrative leader UiO:Life Science and leader of SPARK Norway |
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1705: Regulatory framework in EU – scientific advice and approvals Jan Petter Akselsen, The Norwegian Medicines Agency |
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1715: Classification – is my product a medicinal product? Kristin Odlo H?ye, The Norwegian Medicines Agency |
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1725: Non-clinical requirements for FIH clinical trials Anne Soleng, The Norwegian Medicines Agency |
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1735: How to get approval before starting a clinical trial Anette Solli Karlsen, The Norwegian Medicines Agency |
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1745: Regulatory framework for medical devices Bj?rn Kristian Berge, The Norwegian Medicines Agency |
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| 1755: Questions | |
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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).