An informative and lively regulatory panel discussion was held at the 2023 ISPE Europe Annual Conference in Amsterdam, The Netherlands on 9 May 2023. The session included regulators from the European Medicines...
An informative and lively regulatory panel discussion was held at the 2023 ISPE Europe Annual Conference in Amsterdam, The Netherlands on 9 May 2023. The session included regulators from the European Medicines...
The ISPE Drug Shortages Initiative Team conducted a webinar on 9 February 2023 to discuss regulatory and industry insights on drug shortage prevention with a focus on the Asia-Pacific region. The webinar was moderated by Vivien Santillan, Regional Director, Asia, Novatek International. Regulatory speakers were Lisa Hedman, Group Lead for the Division of Supply and Access to Medicines of the...
ISPE is launching a new program, Enabling Global Pharma Innovation: Delivering for Patients in support of many regulatory agencies’ ambitions to promote introduction of innovative pharmaceutical manufacturing. It is incumbent for industry to modernize and innovate pharmaceutical manufacturing to improve efficiency and increase confidence in quality assurance for the benefit of...
At the 2022 ISPE Europe Annual Meeting held in Madrid on 25-27 April 2022, Evdokia Korakianiti, Head of Quality and Safety, European Medicines Agency (EMA), gave a keynote presentation of EMA’s approach to...
At the ISPE Europe Annual Meeting held in Madrid on 26 April 2022, Nandini Rakala, Data Scientist & Visiting Associate, Office of Pharmaceutical Quality, CDER, FDA gave a keynote presentation on FDA’s...
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...