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Rapporteur article, deconstructs the text of the final guideline (EMA/CHMP/QWP/245074/2015) comparing it to the outdated 1996 guideline and the 2015 draft version along with summarising the main differences and reviewing stakeholder comments […]

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Congratulations to our colleague Tessa Fiorini-Cohen on graduating with Distinction

Congratulations to our colleague Tessa Fiorini-Cohen, Regulatory Affairs Consultant with Real Generics who recently completed a MSc. in Science Communication and Public Engagement (University of Edinburgh) with Distinction. The MSc. in Science Communication and Public Engagement delves into a variety of science communication and public engagement methodologies and issues. Topics covered include science policy, science […]

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