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 the revised responsibilities of the importer and the distributor under the new regulation
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 at how to generate an effective evaluation of your pharmacovigilance system. This article is an update to an article first...
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 by the small patient population. This article looks at the commonly used strategies for evaluation of post-approval safety and the...
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 it here. 5 years on, we are glad to say that the field has moved on substantially in terms of...
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 and regulatory authorities to operate under business continuity mode, with possible impacts on the standard of work. Public health needs may...
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 binding regulatory document submitted to health authorities and is a mandatory commitment for all Marketing Authorisation Holders in the European...
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 changes can often be a problem for small and medium-sized companies (SME’s). Many of these SME companies consider outsourcing pharmacovigilance...
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 most read and downloaded articles that were written by the team in the past 24 months.
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 indicators in PV. You can download your copy by completing the form below. It is the latest e-book from our...
Download ‘Regulatory Intelligence 8’
Edition 8 of the Acorn Regulatory whitepaper series ‘Regulatory Intelligence’ is out now and can be downloaded from our site. This bumper edition looks at a wide range of sectors including: pharmacovigilance, CMC & pharmaceutical, and medical device. In Regulatory...
