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Rising Summer Temperatures: Protecting Pharmaceutical Warehouses Through GDP Compliance.

Rising Summer Temperatures: Protecting Pharmaceutical Warehouses Through GDP Compliance.

by elena@investinu.ie | May 29, 2026 | Acorn Regulatory News

As summer temperatures continue to rise, warehouses storing pharmaceutical and medicinal products are under increasing pressure to maintain strict environmental standards. Under EU Good Distribution Practice (GDP) guidelines, temperature-sensitive medicines must be...
Artificial Intelligence in Pharmacovigilance (CIOMS WG XIV)

Artificial Intelligence in Pharmacovigilance (CIOMS WG XIV)

by elena@investinu.ie | May 18, 2026 | Acorn Regulatory News

Purpose This briefing highlights the key implications of the CIOMS Working Group XIV report on Artificial Intelligence in Pharmacovigilance (PV) published in December 2025[1] and outlines considerations for organisations deploying AI in safety surveillance. Strategic...
Brexit Revisited – Are you prepared for the Windsor Framework?

Brexit Revisited – Are you prepared for the Windsor Framework?

by elena@investinu.ie | Jun 4, 2024 | Acorn Regulatory News, Brexit

More than 4 years after the United Kingdom’s exit from the EU in January 2020, the industry is still dealing with the impact of Brexit and the Northern Ireland Protocol. Most recently being the implementation of the Windsor Framework. In March 2023 the EU-UK Joint...
BioPharmaChem Impact 24 Conference

BioPharmaChem Impact 24 Conference

by elena@investinu.ie | May 24, 2024 | Acorn Regulatory News

We were delighted to attend the 1st ever BioPharmaChem Impact 24 Conference which took place yesterday May 23rd in the beautiful surroundings of Fota Island Resort, Cork. This event brought together over 180 delegates from a diverse group of stakeholders to facilitate...
New Guidelines for Environmental Risk Assessment of Medicinal Products: What You Need to Know

New Guidelines for Environmental Risk Assessment of Medicinal Products: What You Need to Know

by elena@investinu.ie | Apr 10, 2024 | Acorn Regulatory News

Guidelines on the Environmental Risk Assessment (ERA) of Medicinal Products for human use EMEA/CHMP/SWP/4447/00 Rev.1 issued on the 15th February 2024 replaces EMEA/CHMP/SWP/4447/00 Corr 2 which has been in effect since 2006.  The updated procedure comes into effect...
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