ATMP Regulations - Comparison of EudraLex Part IV with PIC/S Annex 2A

About the Author

Technical Director - GMP / Regulatory Compliance

PM Group

Alf has more than 30 years of experience in the pharmaceutical and biotechnology industry, working for GSK, Catalent, and Pfizer. At Pfizer, he held multiple...

iSpeak Blog

Emerging Leader Hacker to GAMPer in 10 Weeks

9 May 2024

The following blog post was provided by Peyton Myers, an undergraduate student at Appalachian State University. Myers attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient.

iSpeak Blog

Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization

30 April 2024

The integration of data science in biopharmaceutical manufacturing, emphasizing data quality, tech transfer efficiency, and process optimization, is the heart of this track. Led by industry experts, discussions explore leveraging digital twins, predictive analytics, and continuous improvement initiatives. Additionally, interactive roundtable discussions provide attendees with a dynamic forum...

iSpeak Blog

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

29 April 2024

The pharmaceutical sector stands at a crossroads of immense possibilities. We are witnessing an unprecedented surge in innovation, fueled by a remarkable partnership between industry and regulatory authorities. For example, there are initiatives fostered by the US Food and Drug Administration (US FDA) to promote innovation with programs such as CATT (CBER Advanced Technologies Team) and ETP...

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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