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 patient health and safety throughout the complete product lifecycle.   Meet the Expert: Tim Kolbrink, Pharmacovigilance Consultant Tell us what you do at ProPharma Group?  I work as a Pharmacovigilance (PV) consultant with a wide range of tasks e.g., acting as QPPV, providing PV trainings, case processing, and writing SOPs, procedures, and work instructions for our customers. As a QPPV, I ..read more

What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence is the act of gathering and analyzing publicly available regulatory information, communicating the implications of that information, and monitoring the current regulatory environment. Regulatory intelligence is about remaining up to date with changing regulatory requirements as implemented by governments and regulatory authorities. These apply to both medicinal products and medical devices in development and authorized on the market. This means that new or changed PV-relevant regulatory inf ..read more

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 patient health and safety throughout the complete product lifecycle. Meet the Expert: Victor Mattisson, Pharmacovigilance Consultant Located in: Stockholm, Sweden Can you tell us about your role? Currently, I work within the PV field which is covering the full lifecycle of drug safety starting from clinical trials through launch, marketing authorization, and maintenance of the product on the market ..read more

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 already formally left the EU (back on 31 January 2020), and we’ve been progressing through a transition period that is expected to end on 31st December 2020. In this 11-month period, it has been easy for Brexit to have temporarily slipped from our thoughts as pharmacovigilance activities have continued to follow the existing EU rules/legislation and a comfortable ‘status quo’ has resumed for a whi ..read more

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 children’s childhood vaccination programs. This blog is on preventive vaccines only. First of all, vaccines in the regulatory field should be treated just as any other medicinal product: a vaccine should be safe and effective, tested in a sufficient number of humans, and have a favorable risk-benefit balance. It should have the ‘normal’ product information, risk management plan, and the same regulatory ..read more

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 Review Boards.” On April 16th, the Agency issued an update that included a question and answer section. With this blog, we hope to provide more clarity into this update and provide a resource for those in the midst of a clinical trial. If you missed part one of this series, you can read it here. Ongoing clinical research that has the potential for patient benefit should be continued; ongoing ..read more

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 recommendations and measures. Please note that information changes rapidly. Always check the applicable websites (EMA, Health Authority in your country, Inspectorate, etc.) if you need more information.  “There was a subject in the trials that had a cough and I asked the sponsor what to do. The sponsor said the patient should be tested before being kept in the ongoing clinical trial” What would ..read more

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 patients and healthcare professionals as well as performing critical Adverse Event intake and processing. Yet, around the world, many MI and PV teams are facing unforeseen challenges due to increased case volume as well as operational and logistical issues, which threaten service delivery and regulatory compliance. With a customer and patient-centric approach to service delivery, ProPharma Group has suc ..read more

ProPharma Group has launched a “Meet the Expert” series to introduce 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 support clients’ complex challenges throughout the complete product lifecycle. Meet the Expert: Terry Hietpas, Principal Pharmacovigilance Specialist Can you tell us what you do?  As a Principal Pharmacovigilance Specialist, I perform a variety of functions within the PV department including case report review, drafting the analysis aspect of aggregate safety reports (PADERs, PSUR/PBRERs), reviewing ..read more

Introduction Every marketing authorisation 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 Pharmacovigilance (QPPV) is central to this system. However, many European countries also require a Local Person for Pharmacovigilance (LPPV) to report to the QPPV. While the requirements and responsibilities of a QPPV are laid down in EU legislation (article 23 of regulation (EC) No 726/2004), LPPVs are subject to their own national legislation. In practice, this means that there are ple ..read more