What The Shift To The EMA's PMS Means For Industry

The abstract summarizes the implications of the shift to the European Medicines Agency's Pharmacovigilance System Master File (PMS) database for the pharmaceutical industry. It mentions how PharmaLex is assisting the industry in adapting to the new system by providing specialized services and training. The abstract also discusses the importance of understanding targeted medicines and how the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is working to improve their safety and effectiveness. It highlights the pressure on marketing authorization holders to update and maintain their product data for the PMS database, as well as the activities that companies need to address urgently. The abstract encourages companies to conduct a thorough analysis of their migrated information to ensure accuracy and mentions the need for more data to be added to the PMS in the future. It also mentions that the abstract is a promotional message from PharmaLex and provides a contact form for inquiries. Finally, it mentions the related blog articles on topics such as confirmatory clinical studies and biosimilars that are available on the website, along with information about the company and its solutions.