Hello everyone,
This is Renée Matthews, Senior Editor of RAPS' RF Quarterly (latest issue and all articles). I'm reaching out to your group to let you know that we are looking for authors for the September 2024 issue of RF Quarterly, which publishes in-depth, peer-reviewed content on emerging issues in the global regulatory landscape.
The issue will focus on Artificial Intelligence in Regulatory Affairs. Articles will address issues addressing all aspects of AI within the clinical, laboratory, and manufacturing settings in the US, EU, and elsewhere.
We are particularly interested in receiving articles on different regions of the world. Your contribution could focus on Brazil or the LATAM region.
Possible topics could fall within the following broad areas, but need not be limited to:
- Legislation – Developing legislation for AI use in the medtech and pharmaceutical industries, e.g., the EU's AI Act
- Standards – Global and regional efforts to harmonize AI in the regulatory setting, e.g., by the WHO, ISO, ICH, ASEAN, and IMDRF
- Health agency efforts at addressing AI use and good machine learning practice, e.g., the EMA's artificial intelligence workplan; the MHRA's AI Airlock; FDA guidance on AI in drug manufacturing and drug/biological product development; and other agencies such as ANVISA, TGA, Health Canada, and SAHPRA, and so on.
- Research – Update on new and emerging technologies
- Case studies – Practical examples and critical assessments of AI tools used for diagnostics, devices, and drug development; medical and regulatory writing, submitting applications; manufacturing; strategizing, and regulatory intelligence
The due date for submission is Monday, 15 July 2024.
Authors could earn 5 RAC credits for their contributions.
Prospective authors should be regulatory professionals with expertise or a focus in the topic area.
Please note Articles must be informed by authors' residual regulatory knowledge and supported by original-source references. AI-generated content and/or content that promotes a tool or service provided by an author or the company they work for will not be considered for publication.
Read the Guidelines for Authors to learn more about RF Quarterly (latest issue and all articles) and Regulatory Focus (all articles) and how to submit an article. For more information, email rmatthews@raps.org
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Renée Matthews
Senior Editor, RF Quarterly and Regulatory Focus
RAPS
Rockville, MD
United States
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