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2025 January
Product to be Used with Needle Rollers: Cosmetic or Medical Device?
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2022 June
Approaches to include drug substance quality information in a drug product application
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2021 June
How to select a cell line to produce a biosimilar
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2021 May
Combination products in the EU MDR
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2020 June
News on the Postponement of the EU Medical Device Regulation, Corrigenda and MDCG guidance
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2020 March
EU MDR impact on importers and distributors
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2019 December
Biopharmaceutical products – Do you have your reference standard program in place?
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2019 October
Radiopharmaceuticals – How to Register in EU?
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2019 July
Is your Active Pharmaceutical Ingredient quality control strategy up to standard?
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2018 December
What is new under the EU MDR for software manufacturers?
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Iryna Berchak
RA Consultant
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