Entries by san-adm

Is paradigm shift is close to us? – EMA’s public consultation on evaluation of anticancer medicinal products

European Medicines Agency (EMA) recently published an open consulation about the evaluation of anticancer medicinal products. The concept paper anticipates that EMA considering to change the current assessment procedure from indication (location) based approval to the pathological mechanism approach. For details please check the original document: https://www.ema.europa.eu/documents/scientific-guideline/concept-paper-revision-guideline-evaluation-anticancer-medicinal-products-man_en.pdf The partial implementation of this new approach had […]

What kind of effect does automation have on your job as Regulatory or Pharmacovigilance professional?

Nowadays you can hear about automation even in the grocery near to your home. Accountants, brokers, cashiers, taxi and truck drivers, lawyers can read articles about fast growing start-ups which are planning take their jobs via automation. But somehow our field as regulatory and pharmacovigilance professional looks safer. We are communicating with local offices, external […]

Are you preparing for Marketing Authorization Transfer? You should check your process again for important little details

Marketing Authorization Transfer (MAT) can cause seriuos extra workload on every related departments. As a consequence sometimes there is not enough time to ensure tha cross-departmental communication flows efficiently and important details can be missed out. Most of the administrative work is done by the Legal and Regulatory Departments but clear communication among Pharmacovigilance and […]