The Quality Overall Summary (QOS) is an element of a drug marketing application that provides a substantially condensed summary of the quality-related data provided in the submission. Regulators can use the QOS to more effectively assess applications and more rapidly comprehend the quality information in the context of patient risk, including the proposed control strategy and any other planned steps to mitigate that risk. Patients benefit from the greater assessment efficiency by having improved access to drugs that are designed and manufactured to consistently and safely fulfill claims in the label.
Artigos recentes
- CREDITAÇÃO DA OF PARA A FORMAÇÃO ” CTD MODULO 3 “
- Applying in parallel with an EU marketing authorisation application
- Notified bodies’ audits performed in the context of quality management system assessment
- FORMAÇÕES 2021 : CREDITAÇÕES PELA ORDEM DOS FARMACÊUTICOS.
- Calendário de formações 2021
- IMPLEMENTATION ROLLING PLAN Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Update dec 2020
- Register medical devices to place on the market
- 14ª Edição da formação sobre as BPD: “Uma revisão abrangente da temática ,que combina a legislação com casos práticos”