EU
MAH
September 3, 2021
The Essential Guide to Local Person for Pharmacovigilance
Every marketing authorization holder (MAH) needs a pharmacovigilance system to guarantee the safety of its products. When setting up a pharmacovigilance system in Europe, the Qualified Person for...
Meet the Expert
Pharmacovigilance
January 27, 2021
Meet the Expert: Tim Kolbrink
ProPharma Group has launched a “Meet the Expert” series introducing you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to improve...
ICSR
RMP
January 7, 2021
Achieving Success with Regulatory Intelligence in Pharmacovigilance
What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence is the act of gathering and analyzing publicly available regulatory information, communicating...
Meet the Expert
Pharmacovigilance
November 24, 2020
Meet the Expert: Victor Mattisson
ProPharma Group has launched a “Meet the Expert” series introducing you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to improve...
Pharmacovigilance
October 13, 2020
Is Your Pharmacovigilance Team Ready for Brexit?
As we approach the final months of 2020, the pharmaceutical world begins, once again, to focus its thoughts on the impact of Brexit, not least in the world of pharmacovigilance. Of course, the UK has...
Pharmacovigilance
August 12, 2020
EMA Vaccine Applications for COVID-19 Explained
Preventive vaccines are a special kind of medicinal product, as they are administered before a disease instead of during. You are probably familiar with preventive vaccines from your own or your...
Pharmacovigilance
Regulatory Sciences
May 15, 2020
FDA Guidance for Non-COVID-19 Related Clinical Trials During the Pandemic
In March 2020, the FDA published a guidance entitled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency - Guidance for Industry, Investigators, and Institutional...
Pharmacovigilance
May 8, 2020
Clinical Trials in the Midst of COVID-19, Part One: European Medicines Agency (EMA)
Disclaimer As of April 23, 2020 Each health authority within the EU has information regarding COVID-19 (coronavirus) on its website. In this blog we will try to guide you through some of these...
Medical Information
Pharmacovigilance
April 14, 2020
Rapid and Responsive Implementation the Right Way: Learn How Preparedness and Adaptability can Protect your Medical Information Delivery during COVID-19
During the COVID-19 global pandemic, Medical Information (MI) and Pharmacovigilance (PV) teams are providing an extremely valuable service to deliver current and accurate product information to...