Advanced Pharmacovigilance and Regulatory Compliance Course
Mentor Based
Duration
3 months
Eligibility
Mode
online
Course Aim
This advanced course aims to provide professionals in the pharmaceutical and healthcare industries with comprehensive knowledge and skills in pharmacovigilance and regulatory compliance. Participants will gain expertise in ensuring the safety and compliance of pharmaceutical products throughout their lifecycle.
Course Objectives
• By the end of the course, participants should be able to:
• Analyze and apply global pharmacovigilance regulations and guidelines.
• Implement effective pharmacovigilance processes and risk management strategies.
• Lead pharmacovigilance teams and initiatives within pharmaceutical organizations.
• Conduct in-depth safety assessments and benefit-risk evaluations.
• Navigate complex regulatory compliance requirements and submissions.
• Communicate safety data transparently and effectively to regulatory authorities.
• Develop pharmacovigilance and compliance strategies for different stages of drug development
and post-marketing.
• Identify and respond to emerging safety issues and trends in the industry.
Program Structure
• The curriculum may include the following modules (subject to change based on the course provider):
• Advanced Pharmacovigilance Regulatory Framework
• Safety Signal Detection and Management
• Benefit-Risk Assessment and Communication Strategies
• Pharmacovigilance Auditing and Inspection Preparedness
• Post-Marketing Surveillance and Safety Surveillance Plans
• Regulatory Submissions and Compliance Requirements
• Pharmacovigilance in Clinical Trials and Drug Development
• Risk Minimization Strategies and REMS Programs
• Crisis Management and Drug Withdrawal Strategies
• Emerging Trends in Pharmacovigilance and Compliance
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
• This course is intended for experienced professionals, including:
• Pharmacovigilance and regulatory affairs professionals seeking advanced knowledge.
• Drug safety and compliance managers and directors.
• Regulatory affairs specialists and professionals.
• Clinical research and development professionals.
• Healthcare practitioners involved in drug safety
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:
• Possess an advanced understanding of global pharmacovigilance regulations and compliance requirements.
• Be able to design and implement robust pharmacovigilance and compliance strategies.
• Lead pharmacovigilance teams effectively, ensuring timely reporting and documentation.
• Conduct benefit-risk assessments and communicate findings to regulatory authorities and stakeholders.
• Develop comprehensive safety surveillance plans for pharmaceutical products.
• Navigate regulatory submissions and inspections with confidence.
• Proactively respond to emerging safety concerns and industry developments.
• Contribute to the overall safety and compliance of pharmaceutical products in the market.
Join Now!
It’s time for you to be enhance your knowledge and be an edge above others. Register yourself and get started today.
