Real-World Evidence regulatory guidance

This guidance provides further clarity around the definitions and use of Real-World Data (RWD) and Real-World-Evidence (RWE) in the over-the-counter (OTC) sector in the UK, based on the different OTC product lifecycle stages.

It also provides a simple guidance and identifies key common elements that need defining while in early phases of a real world project study design.

This guidance covers:

  • Generating RWE from RWD
  • Applications of RWD and RWE across the product lifestyle
  • Practical guidance on conducting Real-World studies

This content is exclusively for PAGB members.

Please login to your PAGB website account to access this content. Or visit our membership pages to find out more about PAGB membership and how you could benefit from our collective and expert voice representing and promoting the sector’s interests.

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