Round-up, week 16 – 20 December 2019

Round-up, week 16-20 December 2019 By Tessa Fiorini-Cohen, Stephanie Allampalli and Marthese Mifsud   Pharmtech series of articles on Pharmacopoeia Compliance 16 December 2019 Pharmtech has published a  series of articles on Pharmacopoeia Compliance. The articles include: Why Pharmacopoeia Compliance Is Necessary Why Pharmacopoeia Compliance Is Difficult A Brief History of Pharmacopoeias: A Global Perspective […]

Read More

Deconstructing the revised EMA guideline on manufacture of the finished dosage form

Source: Regulatory Rapporteur – Vol 14, No 9, September 2018 Authors: Tessa Fiorini Cohen, Claire Corinne Azzopardi, Michelle Gafa Our recently published Regulatory Rapporteur article, deconstructs the text of the final guideline (EMA/CHMP/QWP/245074/2015) comparing it to the outdated 1996 guideline and the 2015 draft version along with summarising the main differences and reviewing stakeholder comments […]

Read More