initiatives regulatory commenting ispe 
ISPE
MAY 22, 2023
Regulatory speakers were Lisa Hedman, Group Lead for the Division of Supply and Access to Medicines of the World Health Organization (WHO); and Joyce Cirunay, Director IV of the Center for Drug Regulation and Research at the Philippines FDA. Hustead Executive Director, Regulatory Affairs Merck & Co.,
ISPE
JUNE 14, 2023
This year was a major success with a wide range of topics addressing advancements in technology and policy initiatives that are transforming the pharmaceutical manufacturing landscape. ISPE conferences provide unique opportunities for engagement and open dialog with global regulatory agencies.
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ISPE
OCTOBER 28, 2022
Combination Products is one of ISPE’s newest Communities of Practice (CoPs). The regulatory frameworks for these products vary from country to country. In the US, each constituent part retains its regulatory identity in a combination product. Why Is Your Communities of Practice’s Work Critical to ISPE and the Industry?
ISPE
NOVEMBER 2, 2022
2022 ISPE Annual Meeting: New Chair, New Year of ISPE Initiatives. 2022 ISPE Annual Meeting: New Chair, New Year of ISPE Initiatives. The gavel passed to a new International Board Chair and ISPE leaders shared 2022 achievements and plans for 2023 at the 2022 ISPE Membership Meeting and Awards Lunch.
European Pharmaceutical Review
NOVEMBER 15, 2022
As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.”
ISPE
AUGUST 7, 2023
Cooke, who has over 30 years of experience in international regulatory affairs, with 18 years in leadership roles, took the helm at EMA as director in November 2020, early in the pandemic, after having worked at EMA since 2002, serving as head of inspections initially and then as head of international affairs from 2009 to 2016.
ISPE
NOVEMBER 1, 2022
2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients. 2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients. Many products launch globally, and regulatory strategies must be data-driven and risk-based. Trudy Patterson. Tue, 11/01/2022 - 06:49.
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