Responsibilities of Importers & Distrubtors MDR

Responsibilities of Importers and Distributors

MDR 2017/745, which  was enforced on May 26th, 2021, expands the responsibilities of importers and distributors. This article will examine… Read more

Pharmacovigilance KPIs

Pharmacovigilance KPIs: How They Can Assist You

How important are pharmacovigilance KPIs in the effective management of a PV system?  We look at the issue and look… Read more

Rare Diseases Focus On Rare Orphan Drugs

Pharmacovigilance of Medicines for Rare Diseases

We look at the issue of pharmacovigilance for orphan or rare diseases.  Many issues associated with the sector are challenged… Read more

Pharmacovigilance & Social Media in 2020

We have been tracking the role of social media in pharmacovigilance in social media since 2015.  We first wrote about… Read more

 COVID-19 may force MAHs and regulatory authorities to operate under business continuity mode, with possible impacts on the standard of work.

The Competent Authorities Response to Covid-19

COVID-19 has transformed almost every aspect of our daily lives. Nevertheless,  patient safety must remain a priority. COVID-19 may force MAHs… Read more

Updated for 2020: A Practical Approach to Risk Management Plans

Writing a risk management plan (RMP) for the first time can be a daunting task. The RMP is a legally… Read more

Pharmacovigilance Outsourcing

Outsourcing Pharmacovigilance for SME Companies

There have been significant developments in the pharmacovigilance sector since the start of the 21st century.  Keeping up with the… Read more

Acorn Regulatory’s Essential Guide to Pharmacovigilance

The Acorn Regulatory PV team works with a range of clients around the world.  Our essential guide looks at the… Read more

PV Update 2 Is Out Now – Download It Here

PV Update 2 looks at issues such as pharmacovigilance and social media, PSUR’s and the importance of monitoring key performance… Read more

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