Regulatory

Fast Track Routes for Medicines that address Unmet Medical Needs

Launch of two-month public consultations on revised guidelines on accelerated assessment and conditional marketing authorization The European Medicines Agency (EMA) has revised its guidelines on the implementation of accelerated assessment and conditional marketing authorization, two key tools in the European legislation to accelerate patients’ access to medicines that address unmet medical needs. Accelerated assessment and […]

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Regulatory Expertise Now Part of QPS Clinical Development Offerings

In July 2015, regulatory expert Patricia Baede joined QPS’ clinical development teams. With 20 years of experience in clinical trial conduct and all regulatory aspects of drug development, Baede adds EU regulatory support to the growing portfolio of clinical activities QPS provides. In the past, she has worked on drug development teams as Phase I

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