Engage with Health Authorities to Mitigate & Prevent Drug Shortages

About the Author

External Collaborations

Genentech Inc

Deborah Tolomeo, PhD, JD, is a Healthcare and Patent Attorney with 15 years of experience in the pharmaceutical and biotechnology industry. Deborah currently works in...

Karen Hirshfield, RPh

Director, Enterprise Regulatory Compliance

Johnson & Johnson

Karen Hirshfield, Director, Enterprise Regulatory Compliance, Johnson & Johnson, performs assessments of quality and compliance risks for external CGMP audits and global health authority requirements...

Diane L. Hustead

Executive Director, Regulatory Affairs

Merck & Co., Inc.

Diane Hustead is an advanced regulatory affairs expert and drug shortage industry leader with enthusiasm and dedication to pharmaceutical manufacturing excellence. With a diverse career...

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...

Online Exclusives

FDA Regulatory Panel: 2023 ISPE Aseptic Conference

1 September 2023

On 7 March 2023, ISPE continued its tradition of concluding the 2023 ISPE Aseptic Conference with a regulatory panel question and answer session. Attendees were invited to submit questions to the FDA representatives. This article offers highlights from the discussion.

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

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