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GMP CANÁBIS 2026 : “Formação conduzida com profundo domínio teórico e prático “
“Muito interessante em termos de conteúdos . Mas também na partilha de experiências . Muito enriquecedor “. NATECH No passado dia 30 de junho decorreu em Lisboa, a formação GMP CANÁBIS , bajo o lema : Visão integrada sobre os processos GACP (NOVA guideline...
MHRA Open consultation Draft rare disease therapies regulatory framework
This novel pathway also places significant emphasis on patient engagement and communication, ensuring that people affected by rare diseases are involved throughout development and that informed consent is an ongoing, not one‑off, process. The guidance also explains...
EU Delegated Acts on Well-Established Technologies (WET) under the MDR
The European Commission has published two delegated acts on Well-Established Technologies (WET) under the Medical Devices Regulation (EU) 2017/745 (MDR) in the Official Journal of the European Union. The newly published delegated regulations expand the list of WET...
CLINICAL TRIALS: EMA CTIS Sponsor Handbook
26 June 2026 EMA/186412/2021 Clinical Trials Transformation Sponsor handbook :Clinical Trial Information System (CTIS) user guidance on the sponsor’s workspace Version 6.3 The most Frequently Asked Questions (FAQs) on CTIS can be found in the Sponsor FAQs,...
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