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
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· 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