RAPS is looking for authors for the September RF Quarterly, which delivers in-depth, peer-reviewed content on emerging issues in the global regulatory landscape. The lead editor for the issue will be Orin Chisholm, PhD, FRAPS, SFHEA, a member of the RAPS Editorial Advisory Committee.
The issue will focus on Global regulatory Harmonization. Harmonization, convergence, and reliance are becoming increasingly important in regulatory affairs. As molecules become more complex, the boundaries between different types of therapeutic products blur and national regulatory authorities (NRAs) are stretched with the necessary expertise to review these new product innovations. Likewise, companies must be aware of these challenges and emerging arrangements in defining their regulatory strategy. In this context, article topics might include, but need not be limited to, the following:
- ICH guidelines and their global adoption (e.g, good clinical practice, multiregional clinical trials)
- PIC/S efforts at harmonizing and standardizing good manufacturing practice
- Work-sharing between NRAs: ACCESS Consortium, Project Orbis, Project Optimus
- Regional harmonization and reliance schemes, such as the African Medicines Agency, ASEAN, APEC, CARPHA/CRS initiatives
- Harmonization initiatives for medical devices such as IMDRF, MDSAP
- Harmonization of advanced therapies such as cell & gene therapy products
- Development of international data and AI standards and their implementation
- Platforms for regulatory collaboration
Read the Guidelines for Authors to learn more about RF Quarterly and how to submit an article. For more information, email rmatthews@raps.org
The due date for the article would be 10 am ET, 14 July 2025.
Please note that AI-generated content will not be considered for publication.
Qualifications:
Regulatory professionals with expertise or a focus in the topic area
Experience Required:
At least 5 years industry experience
Number of openings:
10
Recertification Credits:
5
How to get started:
Email rmatthews@raps.org with your article idea.