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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
IPQ Monthly Update – January 2019 in Review
The January 2019 issue explores: ● the mission, process, and rapidly expanding project portfolio of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) ● the significant efforts of the Gates Foundation, and its newly formed, biotech product-oriented Gates Medical Research Institute, to support CMC innovation that will increase developing world medicines access ● the issues that pharmacopoeial and registration divergences create globally, and the pathways for addressing them, and ● what it takes for biotech companies to avoid GMP compliance problems that can jeopardize application approvals and create manufacturing pitfalls.
