What is TOPRA?
TOPRA is The Organisation for Professionals in Regulatory Affairs. TOPRA is a global professional membership organisation for individuals who work in healthcare regulatory affairs. It provides a range of products and services for all regulatory affairs professionals including support, education and accreditation, and celebrates excellence throughout the sector and profession.
What are regulatory affairs?
Regulatory affairs describes a profession developed from the desire of governments to protect public health. This is by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. This would be undertaken by the companies responsible for the discovery, testing, manufacture and marketing of said products, wanting to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. A new class of professionals emerged to handle these regulatory matters for both government agencies and industry.
What is Regulatory Rapporteur?
Regulatory Rapporteur is TOPRA’s peer-reviewed journal − managed by TOPRA’s publishing team − but commissioned and collated by its Editorial Board which is made up of volunteer members who are subject matter experts. Peer-review articles that go to form the journal output are published monthly − 11 times a year − at www.regulatoryrapporteur.org. The website is also updated with industry news on a daily basis and hosts a podcast of issue reviews and interviews.
The archive of past issues is hosted on the RegRap site but also at TOPRA.org for issues before 2021. All are free to access for TOPRA members.
Each issue is based around a focus topic chosen by the editorial board. Future focus topics can be seen here: www.regulatoryrapporteur.org/future-focus-topics. Each issue will also contain ad hoc ‘standalone’ feature articles which are on topical and relevant subjects. The Editorial Board aims to ensure there are topics of interest across the industry in each issue.