If you’re managing Reference Listed Drug (RLD) updates manually, it might feel like a routine regulatory task. Check updates. Compare documents. Implement changes. Simple enough — until something gets missed. And that’s the real problem. Because in pharma compliance, even a small miss in an RLD update isn’t just an error — it’s a risk that can impact your entire regulatory standing. Why RLD Tracking Demands More Than a Manual Process A Reference […]
You already know how critical Reference Listed Drug (RLD) updates are for your regulatory compliance. But here’s the real question — how long can you continue managing them manually without risking errors, delays, or compliance gaps? Because as your product portfolio grows and updates become more frequent, manual tracking doesn’t just slow you down — it starts exposing your process to […]
If you’re working in regulatory affairs, you’ve definitely come across the term Reference Listed Drug (RLD). But here’s the real question — are you just familiar with the term, or do you actually understand how deeply it impacts your compliance, documentation, and daily workflow? Because in reality, RLD isn’t just a reference — it’s the foundation of your regulatory alignment. What is a […]
The EMEA has published new EudraVigilance Business Rules for exchanging Safety/Acknowledgement Messages and Individual Cases Safety Reports (ICSRs) in the EEA in line with Regulation (EC) No 726/2004, Directive 2001/83/EC as amended, Directive 2001/20/EC, Volume 9A and Volume 10 of the Rules Governing Medicinal Products in the European Union.
Pharmacovigilance Good Practice Guide by MHRA is published by Inspections and Standards Division of the MHRA which assesses pharmaceutical companies’ compliance with UK and EU legislation which relates to the monitoring of the safety of medicinal products.
What is Pharmacovigilance? Pharmacovigilance (PV) is the a science relating to the detection, assessment, understanding and prevention of adverse drug reaction or events or side effects of various pharmaceuticals drugs and medicines.