1 min read
Veristat, in partnership with TOPRA, recently hosted an insightful webinar titled "Future Trends on European Regulations on Medicines." This webinar provided valuable updates on the new Pharmaceutical Strategy for Europe and its impact on the regulatory...
4 min read
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...
1 min read
Veristat and TOPRA recently hosted an informative webinar on the topic of the impact of new EU regulations on the development of medical devices and drug combination products. The European Commission's adoption of Regulation (EU)
2 min read
3 min read
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...
The European Union Medical Device Regulation’s (MDR) Article 117 brings improved patient safety measures with new implications for manufacturers, as they must fulfill a significant set of additional requirements.
2 min read
Explore the growing role of Real-World Evidence (RWE) in the regulatory decision-making process for medicinal products in Europe. Learn how RWE is reshaping the development landscape, its potential benefits, and the challenges associated with its...
5 min read
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...
Comparability studies are a significant issue for those working in biotherapeutics development, as undetected product changes are considered high risk.
4 min read
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...