Search Results - "Stöckert, Isabelle"

Regulatory Flexibilities and Guidances for Addressing the Challenges of COVID-19 in the EU: What Can We Learn from Company Experiences? by Klein, Kevin, Stolk, Pieter, Tellner, Pär, Acha, Virginia, Montagne, Sarah, Stöckert, Isabelle

“…The COVID-19 pandemic required urgency in the development and delivery of effective vaccines and therapeutics; meanwhile, ongoing clinical research, regulation…”
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A case study using the PrOACT-URL and BRAT frameworks for structured benefit risk assessment by Nixon, Richard, Dierig, Christoph, Mt-Isa, Shahrul, Stöckert, Isabelle, Tong, Thaison, Kuhls, Silvia, Hodgson, Gemma, Pears, John, Waddingham, Ed, Hockley, Kimberley, Thomson, Andrew

“…While benefit‐risk assessment is a key component of the drug development and maintenance process, it is often described in a narrative. In contrast, structured…”
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