The transition to IVDR introduces new challenges for IVD manufacturers, with stricter requirements and revised timelines to ensure compliance
Medicines in Europe need Marketing Authorization and ongoing safety monitoring to ensure compliance and patient safety.
New ICH Q2 (R2) and ICH Q14 set to revolutionize analytical method validation in the pharmaceutical industry, enhancing quality, safety, and.
Learn about the importance of clinical and pre-clinical trials for veterinary medicinal products, including regulatory requirements, study types, and.
From streamlining processes to enhancing data analytics, learn how embracing digital technologies revolutionizes industry operations.
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.
2 of the 10 recommendations could be considered the main important to follow: they underline the importance to act preventing and to manage the.
