Let’s dive into something that's reshaping the landscape of the pharmaceutical industry: Big Data.
Big Data isn't just a trend; it's a revolution. Imagine vast amounts of data from clinical trials, patient records, genomics, spontaneous adverse drug reaction reports and even social media insights. But it's not about the size; it's about what we can DO with it!
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) are leading the way through the EMA and HMA Big Data Steering Group.
Here's a glimpse into their workplan:
- DARWIN EU (Data Analysis and Real World Interrogation Network):
Launched in early 2022, DARWIN EU is a network of data, expertise and services which provides timely and reliable evidence on diseases, populations and the use, safety and effectiveness of medicines for human use from real-world healthcare databases across the European Union (EU).
The real-world evidence (RWE) generated by the DARWIN EU supports EMA’s scientific committees and national competent authorities in EU Member States throughout regulatory processes. This means better decision-making and improved patient safety.
In 2024, EMA expects DARWIN EU to be fully operational.
- Metadata List:
Think of it as the index to your favorite book. The metadata list, adopted in June 2022, describes real-world data (RWD) sources and studies.
This metadata list will feed into two future EU catalogues on RWD sources and studies, replacing older catalogues. It will make easier for pharmaceutical companies and researchers to identify and use valuable data.
- Real-World Data (RWD) and Real-World Evidence (RWE):
RWD is like a treasure chest of observational data stored in electronic health records and disease registries. RWE, on the other hand, is the gold we extract from that treasure chest through analysis and/or synthesis.
By using RWD and RWE alongside data from clinical trials, we can speed up medicine development and enhance post-marketing safety and effectiveness monitoring. It's like turbocharging our knowledge about medicines!
By 2025 RWE will be the go-to tool to:
- Plan and validate studies by applicants
- Understand the clinical context
- Investigate the impact of regulatory decisions
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