Sempre na vanguarda da melhor formação técnica dos profissionais da área Pharma , MedTech e Suplementos Alimentares
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2025 AI Observatory report
Artificial Intelligence (AI) is fast evolving and is rapidly transforming the development and supervision of medicines. The EU AI Act entered into force in 2024 and represents a significant step towards ensuring that AI is developed and used in a trustworthy,...
The EU new standard template covering recruitment and informed consent procedures.
The EU has introduced a new standard template covering recruitment and informed consent procedures. The template was developed by MedEthicsEU, the European Commission's expert Ethics Committee group, using insights from more than 11,000 clinical trials authorised...
EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS – Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607
Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices REV. 2. JULY 2024...
MEDTECH EUROPE : An Improved Regulatory Framework: What Do Europe’s Diagnostics Need?
In vitro diagnostics (IVDs) are essential to modern healthcare, guiding clinical decisions from routine testing to advanced diagnostics. As demand continues to grow, it is crucial that the regulatory framework reflects how these technologies work in practice. The...
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