Cliniminds Pharmacovigilance & Drug Safety Training Solutions

About Cliniminds

Since 2004, Cliniminds has been at the forefront of the life sciences sector training. In 2009, we started pharmacovigilance training first time in India and today we are recognized globally as a leader in delivering high-quality programs. With over 6,000 professionals trained worldwide in pharmacovigilance domain, we offer practical, industry-relevant expertise to individuals and organizations. Cliniminds programs are meticulously designed to equip professionals with the skills required to excel in the ever-evolving pharmacovigilance and drug safety landscape.

Comprehensive Pharmacovigilance & Drug Safety Training Programs

1. Key Global Pharmacovigilance Regulations

   • Overview of regulations: USFDA, EMA, MHRA, PMDA & CDSCO
   • ICH E2E Guidelines for Pharmacovigilance.
   • GVP modules and their implementation in different regions.
   • Local regulatory requirements in Asia, Africa, and Latin America.
   • Updates on post-marketing surveillance requirements.

2. ICSRs (Individual Case Safety Reports)

   • Basics of ICSRs and regulatory requirements.
   • Case data collection and processing.
   • MedDRA and WHO Drug coding.
   • Narrative writing for ICSRs.
   • Seriousness assessment and causality assessment.
   • Follow-up strategies for incomplete cases.

3. Medical Review of Adverse Events (AEs)

   • Principles of medical review.
   • Case prioritization and triage.
   • Ensuring medical accuracy and completeness.
   • Analyzing clinical data for adverse events.
   • Quality checks and cross-functional collaboration.

4. Aggregate Report Writing

   • Preparation of:
     • Periodic Safety Update Reports (PSUR).
     • Periodic Benefit-Risk Evaluation Reports (PBRER).
     • Periodic Adverse Drug Experience Reports (PADER).
     • Development Safety Update Reports (DSUR).
   • Literature search and inclusion.
   • Risk-benefit analysis.
   • Best practices for compliance and submission.

5. Signal Detection & Risk Assessment

   • Basics of signal detection and management.
   • Use of EVDAS and other signal detection tools.
   • Signal validation, prioritization, and evaluation.
   • Communication and documentation of signals.
   • Integration of signals into risk management plans.

6. Risk Management Plans (RMPs) & REMS

   • Structure and components of RMPs and REMS.
   • Differences between European RMPs and US REMS.
   • Designing and implementing risk mitigation strategies.
   • Monitoring the effectiveness of risk minimization measures.

7. Pharmacovigilance System Master File (PSMF)

   • Structure and maintenance of the PSMF.
   • PSMF content requirements across regions.
   • Quality checks and audits for PSMFs.
   • PSMF updates and communication with regulatory authorities.

8. Pharmacovigilance Technology Training

   • Oracle Argus Safety:
     • Case intake, workflow, and reporting.
     • Configuration and administrative training.
   • ArisG/LSMV:
     • Basics and advanced functionalities.
     • Data migration and system validation.
   • Introduction to AI and automation in pharmacovigilance.

9. Pharmacovigilance Quality Assurance (PVQA), Audits, & GVP Inspections

   • Overview of PV quality assurance processes.
   • Preparing for internal and external audits.
   • Managing pharmacovigilance inspections by USFDA, EMA, MHRA, and CDSCO.
   • Compliance with GVP guidelines.
   • Root cause analysis and CAPA implementation.
   • Documentation and inspection readiness.

10. Pharmacovigilance & Drug Safety Agreements (SDEAs)

    • Overview of SDEAs and their importance.
    • Key elements of SDEAs and compliance requirements.
    • Stakeholder responsibilities in SDEAs.
    • Monitoring and revising agreements.

11. Pharmacovigilance Budgets & Contracts

    • Budget planning for pharmacovigilance activities.
    • Key considerations for outsourcing PV activities.
    • Contract negotiations with CROs and service providers.
    • Cost optimization strategies.

12. Pharmacovigilance Quality Management Systems (PQMS)

    • Core elements of PQMS.
    • Integration of quality systems into PV processes.
    • KPI development and monitoring.
    • Continuous improvement practices.

Training Methodology

Program Objectives

Program Outcomes