Programas formativos altamente qualificados para a Indústria Farmacêutica
Comprometidos com a qualidade e a inovação.
PRÓXIMAS FORMAÇÕES
ÚLTIMAS NOTICIAS
Considerations for Complying With 21 CFR 211.110 Guidance for Industry
This guidance, when finalized, will describe considerations for complying with the requirements in 21 CFR 211.110 to ensure batch uniformity and drug product integrity. In addition, this guidance discusses related quality considerations for drug products that are...
Final version of its Guideline for Good Clinical Practice E6(R3). Adopted on 6 january 2025
ICH News!! (Good Clinical Practice Guideline E6(R3)) The International Council for Harmonisation (ICH) has today (14 January) announced the adoption of the final version of its Guideline for Good Clinical Practice E6(R3). This update is a major milestone in global...
New EU rules for health technology assessments become effective
EMA is ready to support the implementation of the new regulation on health technology assessment (HTAR) (Regulation (EU) 2021/2282) when it becomes applicable on 12 January 2025. The regulation is an important step forward in accelerating and widening access to new...
ICH Q4B(R1) Guideline on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions Step 5
This document describes the process for the evaluation and recommendation of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable by the ICH regulatory members. This process was initially under the...
