Is a Globally Harmonized Quality Overall Summary Possible?

About the Author

Consultant

Retired

Beth Kendsersky was a Senior Director in Global Regulatory Affairs, Chemistry, Manufacturing, and Controls at Pfizer; she has retired. Beth led a team and managed...

Jennifer L. Brown

Senior Director, Global Regulatory Affairs, CMC

Pfizer

Jennifer L. Brown is a Senior Director in the CMC group within Global Regulatory Sciences at Pfizer Inc in Groton, Connecticut. She and her team...

Connie Langer

Senior Director, Quality Operations/Environmental Health & Safety

Pfizer

Connie Langer is a Senior Director and leader of the Regulatory Intelligence Team within Pfizer’s Quality Operations and Environmental Health and Safety department. This team...

Roger Nosal

Head of Global Regulatory Strategy and Submissions

NGT Biopharma

Roger Nosal is currently Principal Consultant with Roger Nosal PharmaCMC Regulatory Consultants and serves as Head of Regulatory Strategy for NGT BioPharma Consultants, a consortium...

Features

Digital Display Labeling in Clinical Supplies for Clinical Trials

1 March 2024

Digital display labels (DDLs) offer an alternative solution to eliminate manual relabeling in the clinical supply chain, optimizing label content updates through a simple, system-controlled approach while providing new, uncharted opportunities. With increased efficiency in making regulatory-compliant changes and enhanced flexibility in the clinical supply chain, DDL technology has the...

Features

Evolving China’s Regulatory System in Alignment with ICH

1 March 2024

With the Chinese government initiating drug regulatory reform in 2015 and China joining the International Council for Harmonisation (ICH) in 2017, a significant number of measures have been implemented by the government. The aim is to make fundamental changes to China’s drug regulatory administration system so it can facilitate pharmaceutical development and better meet patient needs in the...

Features

Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact

1 March 2024

The Asia Pacific region (APAC), like any large territory, encompasses a blend of well-established and early-stage economies, diverse healthcare systems, and differences in language, culture, politics, and technology adoption. APAC’s size and complexity has created new challenges and opportunities for the pharmaceutical industry as nations work together to meet the manufacturing needs for...

About the Author

Facilities of the Future: Meeting the Demands of Breakthrough Therapeutics

Emerging Leader Hacker to GAMPer in 10 Weeks

New Initiative Seeks to Back up ICHs Harmonization Mission

Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization

Entering a New Era of Innovation and Collaboration With the Focus on the Workforce of the Future

Q&A with ISPE Foundation Professional Development Grant Recipient Silas Tamufor

Related Articles