Pharmacovigilance aims to detect, assess, understand and prevent adverse effects or any other drug-related problem. Since the EU law entered into force in July 2012 (REGULATION (EU) No 520/2012 of 19 June 2012), marketing authorization holders are required to operate a pharmacovigilance system.
Our expertise covers local, European and global pharmacovigilance processes in various therapeutic areas (Oncology, Neurology, etc.), as well as different health technologies: Drugs, Medical Devices, Biologics, Combination Products, etc.
How can DDR help?
- DDR and its network of experts will offer regulatory expertise on pharmacovigilance requirements, by supporting new activities, providing advice and assisting in the optimization of existing processes, according to Good Pharmacovigilance Practices (GVP).
- Assessment of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs).
- Preparation for inspections by conducting a compliance review and Gap Analysis.
- DDR will support compliance with GVP by building the Pharmacovigilance System Master file, Pharmacovigilance Quality System and assist with audit preparation.