mRNA is back at the 2022 ISPE Biotechnology Conference. Last year we learned from major key players about their journey to develop first time mRNA vaccines against COVID-19 and build manufacturing capacity for billions of doses in less than one year. In 2022 we are revising the relevance of mRNA technology and widening the view beyond the COVID vaccine.
ISPE’s ICH Q12 Implementation Team, a technical team under the auspices of ISPE’s Product Quality Lifecyle Implementation (PQLI)® committee, recently worked with Health Canada (HC) to develop and...
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)’s Quality Risk Management (QRM) guidance was signed off by ICH in November 2005 as one of a suite of guidelines alongside Q8, Pharmaceutical Development, Q10, Pharmaceutical Quality System and later, Q11, Development and Manufacture of Drug Substances, which describe the science- and...
ISPE’s Analytical Method Strategy/ICH Q2(R2) & Q14 team, a working group within ISPE’s Product Quality and Lifecycle Implementation (PQLI)® Committee, to lead ISPE’s comments on the ICH documents to regulatory authorities.
A panel discussion held on 26 April during the 2022 ISPE Europe Annual Conference focused on Sustainability, Annex 1 Revision Implementation, and Good Engineering Practice and highlighted the many linkages...
A panel discussion held on 27 April 2022 during the 2022 ISPE Europe Annual Conference focused on Digital Transformation.
Think Tanks are meant to mobilize expertise and ideas to influence processes and procedures and help address global issues – a concept perfectly in line with the goals and mission of ISPE, the pharmaceutical industry’s largest nonprofit association committed to connecting over 20,000 peers across 90 countries. Through online and in-person forums, ISPE members can gain industry knowledge, learn...
