The pharmaceutical industry faces considerable challenges throughout the development, manufacturing, and supply of medicines, largely due to the intricate and divergent global regulatory landscape. The adoption of structured data standards and utilization of cloud-based platforms offer immense potential to overcome these challenges by facilitating faster and more efficient global...
The ongoing evolution of the pharmaceutical industry, aimed at propelling the next generation of medicines requires the close collaboration with regulators, emphasizing innovation, partnership, and a continued dedication to addressing patient needs. This transformation holds the potential to guide significant advancements in the development and delivery of medicines, leading to improved...
The pharmaceutical industry is constantly evolving, placing a significant emphasis on emerging technologies that facilitate quicker access of medications for patients globally. This unceasing drive for innovation and improvement has led the industry to embrace cutting-edge technologies like data analytics, machine learning, and artificial intelligence. These technologies are not just trends;...
When working with the common technical dossier (CTD), the structure of Module 2 “follows the scope and outline of the Body of Data in Module 3,”
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline on Registration of Pharmaceuticals for Human Use (M4)
While everyone is facing new speed to market expectations, we should consider and discuss why global regulatory barriers are increasing, why science- and risk-based strategies often mean more data are required, and why regulatory approval for new technologies and new medicines seems more challenging than ever before. We can no longer afford to delay innovation, product and process...
