Resultado de búsqueda
ICH is a unique public-private partnership that brings together regulatory authorities and pharmaceutical industry representatives to harmonise technical requirements for drug development. Learn about ICH's mission, history, funding, guidelines, events, publications and more.
- Quality Guidelines
Quality Guidelines. Harmonisation achievements in the...
- Safety Guidelines
Further to the ICH Management Committee’s endorsement of the...
- Guideline Implementation
ICH Official web site : ICH ... Home
- MedDRA
Collaboration ICH and WHO: MedDRA is fully implemented in...
- CTD
M4 : The Common Technical Document. The agreement to...
- Ich Award
Names of recipients of the 2023 ICH Award are listed as...
- Electronic Standards
E2B(R2) Message Specification and Q&A. The first...
- Ich
ICH Guidelines. All Guidelines; Quality Guidelines; Safety...
- Quality Guidelines
ICH Guidelines. All Guidelines; Quality Guidelines; Safety Guidelines; Efficacy Guidelines; Multidisciplinary Guidelines; Index of Guidelines; ICH Standards. MedDRA; CTD; Electronic Standards (ESTRI) Other Work . Reflection Papers & Discussion Groups; Consideration Documents; CIOMS Glossary of ICH Terms & Definitions; ICH PQKM Task Force ...
Quality Guidelines. Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
14 de oct. de 2019 · The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/ pharmacogenomics techniques to produce better targeted medicines.
ICH Official web site : ICH
El Consejo Internacional de armonización de los requisitos técnicos para el registro de medicamentos de uso humano 1 (o ICH, por sus siglas en inglés) es un proyecto que reúne a las autoridades reguladoras de medicamentos en Europa, Japón y Estados Unidos de América y las farmacéuticas para discutir aspectos científicos y técnicos de ...
