PHARMAISSUES aims to foster proximity with its partners by addressing topics of extreme relevance and timeliness for the Pharmaceutical Industry.
Clinical Trials are currently a high-impact topic, and the path from the development of a new drug to the introduction of the new therapy into the market is fundamentally dependent on clinical trials.
The new European Regulation No. 536/2014, which came into force on January 31, 2022, will standardize the procedures to be followed by all Member States, as well as the national competences of each Member State. This regulation will coexist with the national legislation of each country, where each nation is responsible for complementing the respective text.
In this edition, Doctor Mónica Bogas, who is currently responsible for the Clinical Operations Department at Roche Portugal since 2019, presents us with her reflection on the potential, risks and opportunities that the implementation of the European Regulation for Clinical Trials will bring to clinical research.
Therefore, we thank Doctor Mónica Bogas, whose contribution is of great value, as well as all our partners for their continued trust in our services.