Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report - Volume 23, Issue

Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of…

Post-approval regulatory writing – How different is it from writing pre-approval documents? - Volume 23, Issue

Regulatory writing has various facets to it with good writing skills as a preliminary requirement. Well written reports form the basis of all regulatory submissions for marketing approval and its success largely depends on the research information…

Post-approval regulatory writing - Volume 23, Issue

Post-market clinical follow-up insights - Volume 31, Issue

The EU Medical Devices Regulation (MDR) brought about new post-market clinical follow-up (PMCF) requirements for medical devices. Whereas complaint monitoring and literature searches were often sufficient under the Medical Devices Directives (MDD),…

Regulatory submissions of non-interventional post-authorisation safety studies - Volume 26, Issue

The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…

Reporting non-interventional post-authorisation safety studies (NI-PASS) - Volume 26, Issue

Post-authorisation safety studies (PASS), whether interventional or, more commonly, non-interventional (NI), can be used by entities such as the European Medicine Agency´s Pharmacovigilance and Risk Assess ment Committee to oblige drug companies to…

Post-Approval Regulatory Writing - Volume 23, Issue

Regulatory Matters - Volume 29, Issue

Background for immunooncology studies - Accumulated research of more than a century has led to our current  expansive understanding of the vertebrate immune system as a complex, multi-functional, evolutionary unit: a diverse, powerful, and adaptable…

Get real: Avoiding corporate gobbledygook - Volume 24, Issue

One spring morning, I was wandering ‘lonely as a cloud’ with a ‘host of golden daffodils’ before me. Then someone stopped me in my tracks: What do you think of the changes in Big Pharma? The illusion was shattered. There was an ominous…

Good Writing Practice - Volume 28, Issue

Excessive post-noun modification, usually as adjectival prepositional phrases, occurs fre - quently in research writing. Occurring less frequently, and less distracting, is excessive prenoun adjectival modification (i.e., stacked modifi cation). The…