Sixth Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical industry

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Date

Torstai, 7 joulukuu 2023, Koko päivä

Paikka

European Medicines Agency, Amsterdam, the Netherlands

Event summary

The Nitrosamine Implementation Oversight Group (NIOG) was set up by the European medicines regulatory network to oversee the harmonised implementation of the Article 5(3) CHMP opinion on nitrosamines in human medicinal products.

The NIOG will be the main interface between regulators and industry to agree on topics requiring further scientific discussion.

Documents

Agenda - 6th meeting of the Nitrosamine Implementation Oversight Group - Industry Association

Adopted Reference Number: EMA/469661/2023

English (EN) (135.78 KB - PDF)

Julkaistu ensimmäisen kerran:
Näytä

Highlights from the 6th meeting of the Nitrosamine Implementation Oversight Group (NIOG) industry partners (IP)

Reference Number: EMA/INS/GMP/30231/2024

English (EN) (80.94 KB - PDF)

Julkaistu ensimmäisen kerran:
Näytä

Presentation - Nitrosamines survey results implementation of nitrosamines guidance throughout EU MSs

English (EN) (2.86 MB - PDF)

Julkaistu ensimmäisen kerran:
Näytä

Presentation - Update on new developments for nitrosamines

English (EN) (922.62 KB - PDF)

Julkaistu ensimmäisen kerran:
Näytä

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