Collaborative strategies for enhanced regulatory approval outcomes

download, clinical trials, regulation

Protection of human subjects enrolled in clinical trials is the focus of regulation during vaccine development.

The guiding principles behind agency interactions during development are as follows:

· To understand the regulatory requirements at each stage of development

· Guidance documents outline general considerations, but program-specific input is essential

· Agency engagement may provide insights

· New data or information can influence the discussion

· Clinical development programs intended to support global licensure require feedback from multiple agencies

Vaccine development presents unique challenges

· Complexity in manufacturing and product characterization− Link between process, analytical and clinical development

· Development cycles are relatively long− Greater likelihood that new information/questions may arise which influence the development path

· Benefit-risk considerations for prophylactic products intended for broad use mean high safety hurdle

· These factors have the potential for increasing program risk− Agency engagement and feedback during development is an important element of managing this risk

Discover more about collaborative strategies for enhanced regulatory approval outcomes, by downloading this presentation here >

· Increasing communication between regulators and trial organisers

· Regulatory criteria for early and late stage trials

· Risk assessments in clinical trials, pre and post-licensure

Dr Keith Chirgwin, Vice President, WW Regulatory Group Leader, Merck

For more information about the topics discussed, please click here >

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