I might be saying it too often: the pharmaceutical industry is highly regulated. But what regulates our practices? It could be federal codes, regulations, directives or even guidance. There are national or regional legislations and there are international harmonisations. For anyone working in this arena or for anyone working in the industry, how do we better memorise these incredibly huge amounts of regulations (which are constantly evolving), how do we understand the contents and the relationship among different regulations?
Inspired by my Qualified Person (QP) training on Pharma Law and Legislation by NSF International – Health Sciences, I’ve started creating a collaborative space for sharing a consolidated Regulation Mind Map with my network.
This free resource is built on the Klaxoon platform for easy collaboration with anyone, and the unlimited space gives us the possibility to grow this Mind Map to any complexity and dimension.
The board was started with EU regulations concerning API, Excipients, Human Medicinal Product, Veterinary Medicinal Product, IMP and ATMP. The potential is to grow it to include regulations for other products (i.e. medical devices), for other regions (i.e. US FDA), and other areas of concern (i.e. GCP). Certainly, the more collaborations I receive from you, the more powerful we will be able to build this tool.
Click here to access the board. It is best to register a free Klaxoon account with your email to make it easy for you to come back to the board anytime and to access Nd’s other/future resources on Klaxoon.
Hope you enjoy it. Get in touch if you have any comments or suggestions to help improve the Regulation Mind Map.
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With 15 years of experience in the global pharmaceutical industry, predominantly in Process, CQV, Process Automation and Project Management, Shanshan has held both Consultant and End User roles. With increasing involvement in the GMP remediation and GMP audit projects, she has been building in-depth compliance knowledge as well as interaction with authorities globally.