RAPS is looking for authors for the February 2025 issue of Regulatory Focus. This monthly publication delivers in-depth, peer-reviewed content on emerging issues in the global regulatory landscape.
The issue will focus on Data Management in Regulatory Affairs. All of us in RA deal with data every day, be it for preparing submissions to the regulators, developing regulatory strategies, responding to queries from authorities, or many other activities.
No matter what specific activity you are involved in, you will have experienced or developed best practices, or maybe found ways to overcome challenges. That could involve keeping data safe (e.g. cybersecurity), private, and assuring trustworthiness of data (e.g. data integrity), optimal extraction of data or presentation of information for regulatory use (e.g. submission preparation), to name just a few examples.
In addition to cybersecurity, data integrity, and submission preparation, possible topics could include, but need not be limited to:
- Global data protection and privacy (e.g., GDPR, HIPPA, CCPA, APPI, China data security rules)
- Good clinical data protection practice
- IT infrastructure, data isolation, transmission, and security
Our readers really want to hear your stories, learn from your experiences, familiarize themselves with terminology (e.g., ALCOA), or just check that their data management practices are sound and proper.
So please consider sharing your knowledge and insights by sending us evidence-based articles, informed by real-world experience, on all aspects of data management in the regulatory setting. We can’t wait!
Authors could earn 5 RAC recertification 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
The due date for the article would be Wednesday, 8 January 2025.
Prospective authors should be regulatory professionals with expertise or a focus in the topic area.