Regulatory Update

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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...
Regulatory
ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. ISPE Launches Initiative on Enabling Global Pharma Innovation Enabling...
Regulatory
ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. ISPE’s Advancing Pharmaceutical Quality (APQ) Program Fully Launched...
Regulatory
ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. Are you ready to implement ICH Q9(R1)? That question was at the heart...
Regulatory Newsletter
ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. Regulator/Industry Panels at ISPE European Annual Conference A panel...
Regulatory Newsletter
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...
Regulatory Newsletter
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...
Regulatory Newsletter
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...
Regulatory Newsletter
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...
Regulatory Newsletter
ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. Dialogue with Regulators ICH Q12 Implementation Strategies Discussed...