Our course in Pharmacovigilance and Drug Safety offers a thorough exploration of global pharmacovigilance regulations, adverse drug reaction (ADR) management, and risk assessment strategies. Designed by seasoned industry professionals with over 35 years of clinical research and quality assurance experience, this course provides both foundational knowledge and advanced insights into drug safety practices.
Course Highlights:
-
Global Regulatory Frameworks: In-depth coverage of pharmacovigilance regulations across the EU, US, and ICH guidelines, ensuring compliance with international standards.
-
Adverse Drug Reaction (ADR) Management: Detailed instruction on the identification, categorisation, and reporting of ADRs, including expedited reporting and MedDRA coding.
-
Signal Detection & Risk Assessment: Comprehensive modules on safety signal detection, risk management planning, and the preparation of Periodic Safety Update Reports (PSURs), PBRERs, and DSURs.
-
Practical Application: Interactive case studies and real-world scenarios to reinforce learning and application of pharmacovigilance principles.
-
Certification: Upon successful completion, participants receive a widely recognised certification in Pharmacovigilance, enhancing career prospects in clinical research, regulatory affairs, and drug safety.
Who Should Enrol?
This course is ideal for professionals in the pharmaceutical, biotechnology, and clinical research sectors, including:
-
Pharmacovigilance and Drug Safety Officers
-
Regulatory Affairs Specialists
-
Clinical Research Associates and Coordinators
-
Quality Assurance and Compliance Managers
-
Medical Affairs and Safety Physicians
Download Course Summary Leaflet
Click the link above to explore the complete course content in our PDF leaflet.
