Regulatory Services in Mexico
Regulatory Services in USA
Regulatory Services in Canada
Regulatory Services in Malaysia
Regulatory Services in Singapore
Regulatory Services in India
Regulatory Services in China
Regulatory Services in Indonesia
Regulatory Services in Philippines
Regulatory Services in Vietnam
Regulatory Services in Morocco
Regulatory Services in UAE
Regulatory Services in Kenya
Regulatory Services in Turkey
Regulatory Services in Saudi Arabia
Regulatory Services in Jordan
Regulatory Services in Egypt
Regulatory Services in Colombia
Regulatory Services in Japan
Regulatory Services in South Korea
Regulatory Services in Kazakhstan
Regulatory Services in Italy
Regulatory Services in Latvia
Regulatory Services in UK
Regulatory Services in Belgium
Regulatory Services in Spain
Regulatory Services in Australia
Regulatory Services in South AfricaSafety signals indicate that there is a potential adverse event linked to a pharmaceutical product. In this case an additional investigation would need to be conducted to confirm the causality. The signal management procedure consists primarily of three steps- signal detection, validation, and confirmation- and are an integral part of pharmacovigilance. The procedure detects changes in risks that are associate with products after ICSR, literature and aggregate report data examination and provide recommendations on what necessary actions are required by regulators or healthcare professionals. Regulatory authorities require that the processes involved in signal management are tracked and documented to ensure they are compliant.
DDReg’s signal management expert team of medics conduct meticulous analysis to identify data to determine early signal detection. Additionally, our team liaises with customers to develop signal detection plans and monitoring processes and use a combination of proprietary and publicly available safety data to help achieve this. DDReg’s signal management services are consistently reviewed internally to ensure we are maintaining regulatory compliance at each stage.
DDReg Signal Management Expertise:
- Identification new safety signals and/or changes in risks concerning a pharmaceutical product from ICSR database, literature, aggregate reports as well as regulatory agency website monitoring.
- Utilizes a variety of in-house tools and databases for signal detection and tracking signal management processes
- Reviews safety signals for ICSRs, aggregate reports and recommendations by Pharmacovigilance Risk Assessment Committee (PRAC)
- Performs label update analysis
- Provide recommendations from signal assessments which include risk minimization approaches
- Preparation of Signal Management Tracker, Annual Signal Reports.
