Prospective harmonisation of quality standards: A model for pharmacopoeial convergence
Date: 10 June 2022
Time: from 9 a.m EDT/3 p.m CEST to 10 a.m EDT/4 p.m CEST
Location: Webinar - Strasbourg, France
Working language: English
Pharmacopoeial convergence and harmonisation are critical tools to promote the alignment of quality standards to ensure consistent global access to quality medicines for the benefit of public health. The United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.) are committed to working together to pursue effective and efficient avenues for convergence and alignment of quality public standards. Prospective harmonisation provides an opportunity for USP and the Ph. Eur. to align on standards for selected active substances and medicinal products that do not yet have public standards in either pharmacopoeia. This work focuses on medicines that are still under patent (single source), have newly approved applications, and have a strong impact on global public health.
USP and the Ph. Eur. began this project in 2008 as a pilot which resulted in the development of four prospectively harmonised monographs for active substances (Celecoxib, Montelukast sodium, Rizatriptan benzoate, Sildenafil citrate). Following completion of the pilot, USP and the Ph. Eur. continued work through an informal mechanism of information sharing that has resulted in the inclusion of 10 and 9 additional prospectively harmonised active substances and medicinal product monographs, respectively.
This webinar will explore the history of the prospective harmonisation activities between USP and the Ph. Eur., highlight success stories as well as challenges, and share proposed program adjustments based on lessons learned. It will also include an overview of the respective processes for monograph development and present the benefits and advantages of working with USP and the Ph. Eur. for future development of prospectively aligned active substance and medicinal product monographs.
The webinar will take place on 10 June 2022, from 3 p.m. to 4 p.m. (CEST, Paris, France).
This webinar is of interest to professionals working in pharmaceutical companies in quality control, development, manufacturing, and regulatory affairs.
Participation is free of charge.
Send us your questions in advance
Registered webinar participants are invited to submit their questions in advance using the question form below. It will also be possible to send us questions during the webinars, but submitting them in advance will help us focus on the topics that generate the most interest. We cannot promise to answer every question, but all questions are welcome and encouraged.
If you would like to submit a question in advance, please send an e-mail to the Public Relations Division. For organisational reasons, these questions should be submitted not later than 7 June 2022.
This webinar is free of charge.
Places are limited, so sign up today!
Each registered participant will receive a copy of the presentation slides and the link to the webinar recording which they can refer back to if needed in the future.
After registration, you will receive an invitation telling you how to access the webinar and how to test the system beforehand. On the day of the webinar, click on the link in the registration confirmation e-mail.
You can also check your system’s compatibility automatically.
Before registering, please read the Terms of Supply for EDQM Events.