Program Aim:
This course is designed to provide a thorough grounding in the methods and practices for assessing drug safety, this course prepares participants to contribute effectively to the healthcare system by ensuring the safe use of medicines.
Intended For:
This course is ideal for healthcare professionals, including pharmacists, nurses, and physicians, as well as students and professionals in pharmaceutical sciences, regulatory affairs, and public health who aim to specialize in drug safety.
Program Objectives
- To impart foundational and advanced knowledge in pharmacovigilance and drug safety.
- To develop competencies in identifying and analyzing adverse drug reactions.
- To prepare participants to implement effective risk management strategies for pharmaceutical products.
Program Structure
MODULE 1
Introduction to Pharmacovigilance
- Definition and Scope of Pharmacovigilance
- History and Importance of Pharmacovigilance
MODULE 2
Regulatory Aspects in Pharmacovigilance
- International Pharmacovigilance Guidelines (ICH, WHO)
- Regulatory Requirements in the US, EU, and globally
MODULE 3
Adverse Drug Reactions (ADRs)
- Types and Mechanisms of ADRs
- Detection and Reporting of ADRs
MODULE 4
Pharmacovigilance Systems and Processes
- Data Collection and Management
- Signal Detection and Management
MODULE 5
Risk Assessment and Mitigation
- Risk Management Plans
- Strategies for Minimizing Drug Risks
MODULE 6
Pharmacovigilance and Public Health
- Role in Public Health
- Vaccine Safety and Pharmacovigilance
MODULE 7
Quality Assurance in Pharmacovigilance
- Auditing and Inspections
- Best Practices in Pharmacovigilance
MODULE 8
Case Studies and Real-world Pharmacovigilance
- Discussing Real-world Scenarios
- Lessons Learned from Past Drug Safety Issues
What You Will Get?
Program work is completed through online system under the guidance of program coordinator.
Various Job Opportunities
- Pharmacovigilance Officer
- Drug Safety Associate
- Pharmacovigilance Scientist
- Regulatory Affairs Specialist
- Pharmacovigilance Quality Assurance Analyst
Steps For Enrollment
Step-1
Click ‘Apply Here’ and fill in your basic details (Name, Email, Contact, Image).
Step-2
Select Program, Session, Duration, and Fill Payment Details in the Form to Submit.
Step-3
Hurray! You Will Get Your Login Credential Within 48 Hrs.
