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Title
Regulatory Rapporteur May 2022
Summary
Chemistry, manufacturing and controls – Ensuring safe and effective pharmaceutical products Plus: Article: Procedure withdrawals in Europe: past trends, impact and communication recommendations Article: Amgen’s experience of global expedited regulatory pathways in the development of sotorasib
DocumentAccess
Regulatory Rapporteur May 2022MEMBERS
Practical insights into the recent EU MDR frameworkMEMBERS
Gene therapy products: regulatory expectations and challenges for industryMEMBERS
Procedure withdrawals within Europe: past trends, impact and communication recommendationsMEMBERS
CMC considerations for US biosimilars developmentMEMBERS
Regulatory Framework for Platform TechnologiesMEMBERS
A regulatory view on the change management process for medicinal productsMEMBERS
Amgen's experience of global expedited regulatory pathways in the development of sotorasibMEMBERS
CMC acceleration is driven by a scientific revolution PUBLIC