Pharma R&D Today

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How Are Regulatory Agencies Reacting to the Use of Real-World Evidence?

Posted on June 15th, 2020 by

As we have discussed here previously, real-world data (RWD) and real-world evidence (RWE) offer many potential benefits in every stage of the drug discovery and development process, continuing on into post-market surveillance. With drug developers and other researchers becoming more interested in using RWD and the RWE that results from analyzing it, regulatory agencies have had to step up and work on producing guidance.

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Webinar: Using machine learning to identify adverse events from scientific literature

Posted on February 5th, 2020 by

The “vigilance” aspect of the pharmacovigilance process can be very challenging. Always being on guard and knowing all of the places to look can be difficult. In a sea of information, it can even seem like a nearly impossible task to maintain awareness of all adverse events (AE). That is why there has been a lot of buzz around technologies that can help automate parts of the pharmacovigilance process.

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Why literature is a valuable source for signal detection: From the EU point of view

Posted on January 9th, 2020 by

Signal detection is traditionally based on case reporting from healthcare professionals and national regulatory authorities. Yet, there are a number of very notable examples where a safety signal actually came from the scientific literature, such as in the cases of thalidomide, GM-CSF, nifedipine and tamsulosin. (You can learn more about how safety signals detected from a literature report had an impact on the lifecycle of these drugs here.)

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Evidence-based medicine training and seminar coming up in Beijing

Posted on January 3rd, 2020 by

Systematic review of the available literature from clinical trials is important for collecting evidence for existing and new patient care practices. With the ever-increasing amount of literature around this, it becomes important to design literature searches that ensure no important safety signal is missed.

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