Pharmacovigilance Signal Detection & Management
Signal Detection and Management
PDS understands that this forms a big part of our client’s pharmacovigilance activities. We also understand that signal detection and management activities are essential steps for client’s proactive pharmacovigilance.
- RMPs and REMs (Risk Management Plans and Risk Evaluation & Mitigation Strategies)
- The team here at PDS are skilled in writing Risk Management Plans (RMPs) and Risk Evaluation & Mitigation strategies (REMs), in line with the EU GVP Module V– Risk Management Systems requirements and FDA guidance for developing an effective REMs strategy.
- PDS can provide you with a service for just one single RMP/REMS or all of your RMPs/REMS, we ensure we tailor make our service to meet your actual requirements and we further ensure we deliver a quality cost effective service.
The WHO defines a safety signal as: "Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously".
World Health Organisation
Email us now to discuss your project with one of our Team
Together, we’ll safeguard patient health and maintain compliance with confidence.
