NVFG Basic Course Pharmacovigilance (PPN Section)
What does pharmacovigilance (PV) actually entail? What do you need to know and be able to do with regard to the safety of medicines when you start working at a pharmaceutical or research company? For example, in the position of Drug Safety Officer (DSO) or PV employee, at the Registration department, Medical Affairs, Clinical Research, or as Medical Liaison, etc.
For all new colleagues who want/need to know more about PV, the PPN section organizes 2 training days annually consisting of a Basic course and an Advanced course that can be followed independently of each other. Speakers are a mix of PPN board members and externals.
Goal
The training days aim to introduce participants to the pharmacovigilance of human medicines in the Netherlands. Most attention is paid to daily practice.
Who is this course for?
The Basic Course is intended for all new colleagues in pharmaceutical medicine who deal with pharmacovigilance or the Drug Safety department in their work.
The Advanced Course is primarily intended for beginning DSOs (0-1 year experience).
Background
Monitoring drug safety (pharmacovigilance; PV) and associated risk management are of vital importance to drug developers, marketing authorisation holders and clinical investigators.
In addition to the general legal obligation of pharmaceutical companies to protect public health, increasingly demanding regulations are emerging from various governments when it comes to drug safety.
As every pharmaceutical and biotech company has the health and safety of the patient as its top priority, it is of great importance for these companies to ensure that they have efficient pharmacovigilance systems in place and that all staff members are aware of the associated (basic) requirements. The role of the PV department within these systems is essential.
Although the names of the PV functions may vary from company to company, the task of all local Drug Safety Officers is the same: to ensure that patient safety is guaranteed and not compromised when using the company's products. The DSO therefore occupies a special position within a pharmaceutical company.
What skills does a student take home?
The student will be introduced to the essence of pharmacovigilance, governments and (Dutch) legislation. He/she will also get a good picture of the position and role of pharmacovigilance within a company. The student will get to know various relevant authorities in the Netherlands and the EU.
After completion, a certificate of participation will be sent stating whether the final exam has been passed. If not passed, the exam can be retaken in consultation.
14:00, Monday, 19 Oct 2026 + 2 more
14:00, Tuesday, 20 Oct 2026
14:00, Wednesday, 21 Oct 2026
