RAPS is 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.
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
Authors could earn 5 RAC credits for their contributions.
The due date for submission is Monday, 15 July 2024.
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 and Regulatory Focus and how to submit an article. For more information, email rmatthews@raps.org