(C) World Health Organization
This story was originally published by World Health Organization and is unaltered.
. . . . . . . . . .



Week of Quality for Medicines 2024: Registration Now Open [1]

[]

Date: 2024-05-13

WHO is pleased to announce the Week of Quality for Medicines 2024. This virtual training program, organised by the Local Production & Assistance Unit (LPA) within the Innovation and Emerging Technologies Division (IET), builds on the success of the inaugural Week of Quality in 2023. This year, the program has a dedicated week for medicines to focus on strengthening the capacity of manufacturers in low- and middle-income countries (LMICs) regarding quality requirements for pharmaceutical product development and dossier preparation.

A Look at the Week of Quality for Medicines in May 2024

The Week of Quality for Medicines 2024 with the theme Driving pharmaceutical product development forward by navigating quality requirements is specifically designed to equip manufacturers in LMICs with the knowledge and skills needed to navigate the quality requirements for finished pharmaceutical products (FPPs) and active pharmaceutical ingredients (APIs) outlined by WHO and other regulatory authorities and to promote best practices in presenting quality data and information in regulatory documents (Common Technical Document or CTD/eCTD), facilitating smoother reviews and approvals. This, in turn, promotes the availability of safe, effective, quality-assured finished pharmaceutical products.

CTD-dossier preparation Control of impurities in active pharmaceutical ingredients In vitro dissolution testing, equivalence aspects and BCS-based biowaivers for generic finished pharmaceutical products Stability testing for finished pharmaceutical products and active pharmaceutical ingredients.

The Week of Quality for Medicines will be held over four days (May 13-16, 2024) using the Zoom platform (2.5 hours per day, 12:00-14:30 CEST). The program will be delivered through a combination of educational presentations, and engaging Q&A sessions. Participants will enhance their expertise in structuring or formatting regulatory documentation, receive a comprehensive understanding of the current international quality requirements, and strengthen their ability to provide rationales supporting the development and control of medicines. Topics to be presented include:

Registration for the Week of Quality for Medicines 2024 is currently open. Register your interest to participate in this training program. The workshop is designed for manufacturers of FPPs and APIs in LMICs (particularly technical personnel involved in pharmaceutical development, routine production, quality control (QC), quality assurance (QA), dossier preparation, and regulatory affairs). Regulatory authorities (Ministry of Health, National Regulatory Authorities) in all WHO regions are also welcome to attend. Secure your spot by registering your interest. Don't miss out!

Registration deadline: 09 May, 2024

For further information and inquiries about the Week of Quality or LPA's initiatives, please visit the LPA website and contact Dr Jicui Dong, Unit Head of the LPA Unit, at [email protected], copying [email protected].



[END]
---
[1] Url: https://www.who.int/news-room/events/detail/2024/05/13/default-calendar/week-of-quality-for-medicines-2024--registration-now-open

Published and (C) by World Health Organization
Content appears here under this condition or license: Creative Commons CC-BY-NC-SA 3.0 IGO.

via Magical.Fish Gopher News Feeds:
gopher://magical.fish/1/feeds/news/who/

You are viewing proxied material from magical.fish. The copyright of proxied material belongs to its original authors. Any comments or complaints in relation to proxied material should be directed to the original authors of the content concerned. Please see the disclaimer for more details.