News – PrimeVigilance Latest Webinar ‘A Human Touch: Real-World Patient Data in Regulatory Submissions and Beyond’
Published 15 February 2019.
PrimeVigilance proudly present our latest webinar
‘A Human Touch: Real-World Patient Data in Regulatory Submissions and Beyond’, hosted alongside Pharmafocus and features speakers Dr Forstner, Senior VP and Head of Pharmacoepidemiology and Risk Management and Maartje Smulders, Senior Director Pharmacoepidemiology.
This session takes place on Thursday 14th of March 2019 starting at 3 pm GMT (UK), 4 pm CET (Europe), and 11 am EDT (US).
During this webinar, PrimeVigilance’s expert speakers will describe the EMA/FDA ambition for greater use of real-world evidence (RWE), present several case examples of RWE use in regulatory submissions and beyond, and discuss what a future in which patient-centric RWE is commonly used might look like.
This webinar will discuss the following:
First, we will set the stage by briefly describing the current RWE regulatory landscape in the EU and US.
We will then present several case examples of how RWE has been used in regulatory submissions and post launch.
Finally, we will describe what may be forthcoming, namely that generation of safety and effectiveness data outside of clinical trials will continue to develop from a single-source, passive system to an evolving holistic approach based on multiple data sources and study designs. This would allow for a new era in which post-approval effectiveness and safety are predicted on sophisticated analysis of likely benefits and risks prioritised for interrogation. In addition, patient-centricity, collaborative trial design, and technological developments may gradually allow us to shift some studies and data collection to the point of care and the patient home setting, making the development of actionable evidence more efficient.
The webinar will be followed by a Q&A session where you will be able to ask questions and receive direct feedback on key areas of uncertainty.
Click here to book your place today. If you require further information, please do not hesitate to contact us.