Pharmacovigilance in Clinical Trials and Drug Development
Mentor Based
Duration
12 weeks (may vary by course provider).
Eligibility
Mode
Online, with video lectures, case studies, interactive discussions, and practical exercises.
Course Aim
This course aims to provide participants with specialized knowledge and skills in pharmacovigilance as it relates to clinical trials and the drug development process. It focuses on ensuring patient safety, regulatory compliance, and effective risk management in clinical research settings.
Course Objectives
By the end of the course, participants should be able to:
• Understand the role of pharmacovigilance in clinical trials and drug development.
• Identify and report adverse events and reactions in the context of clinical research.
• Comprehend the specific regulatory requirements and guidelines for safety reporting in clinical trials.
• Conduct benefit-risk assessments in the context of investigational drug products.
• Develop risk minimization strategies tailored to the clinical trial phase.
• Collaborate effectively with clinical trial teams, investigators, and regulatory authorities.
• Apply pharmacovigilance principles to improve patient safety throughout drug development.
Program Structure
The course includes specialized modules (subject to change based on the course provider), such as:
• Pharmacovigilance in Clinical Trials: Overview and Importance
• Safety Reporting Requirements in Clinical Research
• Adverse Event Collection and Reporting in Clinical Trials
• Signal Detection and Analysis in Early-Phase Studies
• Benefit-Risk Assessment in Clinical Trial Phases
• Risk Minimization Strategies for Clinical Trial Participants
• Collaborative Pharmacovigilance in Multinational Trials
• Regulatory Submissions and Inspections for Clinical Trials
What You Will Get?
Program work is completed through online system under the guidance of program coordinator.
e-LMS for smarter Learning
24 x 7 open chat box
Excellent option for summer project
Online live lectures from the experts
Prepare real time projects
Certificate on project completion
Various Job Opportunities
Steps For Enrollment
Step 1: Click On The Below Mentioned Link “Apply Here”
Step 2: Fill All Basic Details Of Yours (Name, Email Id, Contact Details, Image)
Step 3: Choose Your Program, Session And Duration Of Program
Step 4: Fill Payment Details In The Form And Submit
Step 5: Hurray! You Will Get Your Login Credential Within 48 Hrs.
Skills to Score
Fee Plan
Basic Course
3 Month Mentor Based Course
INR 12,999/- or USD 199
- Access to e-LMS
- Immediate commencement
- Study material at your doorstep
- Project Guidance from Subject Experts
- Paper Publication Opportunity
- Self Assessment
- Final Examination
- Printed certification
- Printed Marksheet
Advanced Course
6 Month Mentor Based Course
INR 22,999/- or USD 349
- Access to e-LMS
- Immediate commencement
- Study material at your doorstepv Complete Basic Course
- Complementary Scientific Technical Writing
- Real Time Project for Dissertation
- Project Guidance from Subject Experts
- Paper Publication Opportunity
- Self Assessment
- Final Examination
- Printed certification
- Printed Marksheet
Course Outcomes
• Upon completing this course, participants are expected to:
• Understand the critical role of pharmacovigilance in clinical research and drug development.
• Be proficient in identifying, documenting, and reporting adverse events and reactions during clinical trials.
• Comply with regulatory requirements for safety reporting in clinical research settings.
• Conduct benefit-risk assessments specific to investigational drug products.
• Develop risk minimization strategies tailored to the clinical trial phase.
• Collaborate effectively with clinical trial teams, investigators, and regulatory authorities to ensure patient safety.
• Apply pharmacovigilance principles to contribute to the successful conduct of clinical trials.
Join Now!
It’s time for you to be enhance your knowledge and be an edge above others. Register yourself and get started today.
