Discover the power and efficiency of EudraVigilance Data Analysis System (EVDAS) in signal detection for pharmacovigilance. Explore its key features.
Discover the ongoing challenges faced by Veterinary Marketing Authorization Holders and Manufacturers in managing elemental impurities in veterinary.
Learn about SPOR (Substance, Product, Organization and Referential), the European Medicines Agency's requirement for implementing ISO IDMP standards..
The EMA has introduced the QRD Template Version 9.0 for product information used by the MAH. The updated template must be adopted by January 2027.
The important role of Environmental risk assessment (ERA) before applying for marketing authorization in Europe and in the United States.
Trained personnel play a vital role in ensuring medicinal safety in the animal health business. To achieve this, companies must focus on two primary.
Market Authorization Holders are now mandated to undergo the QMS to ensure compliance with the newly implemented laws of the VGVP.
2 of the 10 recommendations could be considered the main important to follow: they underline the importance to act preventing and to manage the.
At the end of April 2023, the EU Commission announced the largest reform of the pharmaceutical sector in over 20 years. Why is this happening right.
Pharmacovigilance System Master File (PSMF), describes the details of the pharmacovigilance system, focusing on the Quality Management System (QMS).