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European Biopharmaceutical Review

IDMP The Year in Review and Looking Ahead to 2021



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Syntegon and Vetter win PDA Drug Delivery Innovation Award for Versynta microBatch

Waiblingen/Germany, October 6, 2021. Together with Vetter, an international pharmaceutical service provider for injectables, Syntegon (formerly Bosch Packaging Technology) has won the PDA Drug Delivery Innovation Award. In the "Partnership Innovation" category, the Parental Drug Association (PDA) honors development projects by pharmaceutical and machine manufacturers that advance the production of (bio)pharmaceuticals. The collaboration between Vetter and Syntegon resulted in Versynta microBatch, a highly flexible and fully automated production cell with a gloveless isolator, the smallest possible dimensions and a complete batch-to-batch changeover of less than two hours.
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The Role of the CRO in Effective Risk-Based Monitoring

Medpace

The clinical trial industry is evolving. In an effort to improve participant safety and data integrity, regulators are encouraging trial sponsors to transition from a focused on-site monitoring approach they have traditionally employed toward a risk-based approach that utilizes a combination of centralized and on-site monitoring techniques to ensure patient safety and data quality. The Risk-Based Monitoring (RBM) paradigm has many potential advantages over established monitoring practices including enhanced patient safety and data integrity, more efficient and effective protocol design, reduced costs, and the ability to strategically adjust oversight in keeping with changes in risk level.
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