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USA – FDA releases guidance on labeling of drug use-related software...
The US Food and Drug Administration (FDA) has released draft guidance with considerations on how to include software outputs of drug use-related software in...
UK – Medical devices: EU regulations for MDR and IVDR (Northern...
This guidance provides information on the EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).
From 1 January 2021 the Medicines and Healthcare...
Europe – Towards a permanent collaboration framework for EMA and Health...
Over the past three years, EMA and the EUnetHTA 21 (European Network for Health Technology Assessment) consortium have delivered a number of milestones to prepare the...
WEBINAR – Nitrosamines et impuretés élémentaires : faire son analyse de...
Intervenants :
Gilles Fonknechten, PhD,
Durant une carrière de plus de 35 ans dans l’industrie pharmaceutique
en CMC, le Dr Fonknechten a participé à la mise sur...
Australia – TGA publishes updated guidelines for sunscreens
The TGA has updated the Australian Regulatory Guidelines for Sunscreens (ARGS) to align with the data requirements for all ingredients proposed to be included in the Therapeutic...
