As regulatory agencies invite public comment on a new or revised regulation or guidance they look to ISPE for input on the latest scientific and technical developments. ISPE submits official comments when we can provide...
ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. Industry Study Finds Divergence in Regulators’ Interpretation of ICH...
ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. US FDA and WHO Highlight Agility and Collaboration at ISPE Annual...
ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. Global Regulators and Industry discuss Shared Responsibility for QRM...
ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. Global Regulators Discuss Remote/Distant Assessments, Audits, and...
ISPE participated in the Department of the Air Force Acquisition COVID-19 Task Force (DAF ACT) to advise Regulatory, Technical, and Workforce elements favorable to creating a more robust and sustainable domestic...
This quarterly newsletter is dedicated to news about ISPE’s regulatory and quality activities. ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry...
ISPE was selected as one of a limited number of focused stakeholders to provide comments on nine questions posed by PIC/S on the draft GMP Guide Annexes 2A for Advanced Therapy Medicinal Products (ATMPs) and 2B for Biological Medicinal Substances. ISPE...
A committee under the auspices of the National Academies of Sciences, Engineering, and Medicine (NASEM) is conducting a study with the aim of producing a consensus report that identifies emerging and upcoming technologies that have the potential to...
The latest ICH guideline, ICH Q12,International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised Guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Q12. Final Version.” 20 November 2019....
