Clinical Research Solutions
The COVID-19 pandemic required manufacturers and importers of medicinal products and regulatory authorities to operate under business continuity mode, impacting the standard way of working. As a...
Clinical Research Solutions
April 12, 2022 The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have published a PDF icon joint work plan until 2023. The focus...
Clinical Research Solutions
April 22, 2022 EMA’s human medicines committee (CHMP) has given a recommendation for two diabetes mellitus treatments, Actrapid and Insulatard, for use outside the European Union (EU). EMA is...
Clinical Research Solutions
What are Breakthrough Therapy Designation and PRIority MEdicines (PRIME) Applications? The advancement of modern medicine, and the accessibility of researched and regulated medication, has greatly...
Clinical Research Solutions
Regulatory Strategy for Clinical Trials in the European Union: Setting up a clinical trial in the European Union (EU) has historically been an expensive and time-consuming business. With 27...
Clinical Research Solutions
How to Manage the Risk of Elemental Impurities with ICH Q3D: The mission of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is to ensure...
Clinical Research Solutions
In response to the COVID-19 pandemic, global regulatory authorities adopted a pragmatic virtual auditing approach. This approach includes the flexibility and procedural simplifications to maintain...