RAPS is looking for authors for the March 2024 issue of RF Quarterly, which publishes in-depth, peer-reviewed content on emerging issues in the global regulatory landscape.
The due date for article is Friday, 23 February 2024.
The issue will focus on Quality in the Regulatory Setting. Articles will focus on quality and compliance at all stages within the clinical, laboratory, and manufacturing settings in the US, EU, and elsewhere. Possible topics could fall within the following broad topic-areas, but need not be limited to:
- Good clinical, laboratory, and manufacturing practice
- Regulatory and guidance documents (ICH, EU, US, and globally)
- Role of the quality unit
- Types of inspection
- Data integrity
- Enforcement
- Quality management systems (background and key elements)
- Quality system regulation and CAPA management
- Safety testing and standards
- Informed consent, review boards, ethics committees, data-monitoring committees
Authors could earn 5 RAC credits for their contributions.
Read the Guidelines for Authors to learn more about Regulatory Focus and how to submit an article. For more information, email rmatthews@raps.org.
Prospective authors should be regulatory professionals with expertise or a focus in the topic area.