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 […]
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Entries by san-adm
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 […]
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 […]
Are you aware that new MedDRA version has been implemented recently? And how about your organization? I will point out a few pharmacovigilance and regulatory processes which are usually missed out during a MedDRA version update. New MedDRA version is delievered twice a year to keep updated more than 100 000 terms covered by the Dictionary. […]