Advanced Good Pharmacovigilance Practices (GVP) Training Course

Advanced Good Pharmacovigilance Practices (GVP) Training Course

Introduction

The pharmaceutical industry's landscape is constantly evolving, driven by rapid advancements in medical science and an increased focus on global patient safety. The critical discipline of Pharmacovigilance (PV), which involves the detection, assessment, understanding, and prevention of adverse effects of medicinal products, is at the core of this evolution. To meet the stringent demands of regulatory bodies like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), and to ensure drug safety across the product lifecycle, professionals must possess a deep and current understanding of Good Pharmacovigilance Practices (GVP).

Advanced Good Pharmacovigilance Practices (GVP) Training Course is designed for professionals seeking to master the complexities of modern PV systems. It goes beyond the fundamentals, providing in-depth knowledge and practical skills in key areas such as signal management, risk management, and regulatory compliance. Our curriculum is structured to equip participants with the expertise to navigate complex global regulations, perform robust safety data analysis, and implement proactive strategies that enhance patient outcomes and organizational integrity.

Course Duration

10 days

Course Objectives

Upon completion of this course, participants will be able to:

• Master the latest EU GVP modules and their practical application.
• Analyze and interpret complex pharmacovigilance data for effective signal detection.
• Develop and implement robust Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
• Navigate the intricacies of global PV regulations and their impact on drug development.
• Perform a comprehensive Pharmacovigilance System Master File (PSMF) audit for compliance assurance.
• Manage and report Individual Case Safety Reports (ICSRs) and aggregate reports (e.g., PSURs, DSURs) with precision.
• Enhance quality management systems (QMS) within a PV framework.
• Prepare for and respond to regulatory inspections with confidence.
• Apply pharmacovigilance principles to clinical trial safety and post-marketing surveillance.
• Leverage digital tools and AI in pharmacovigilance for process optimization.
• Assess the benefit-risk profile of medicinal products throughout their lifecycle.
• Implement corrective and preventive actions (CAPA) for identified PV deficiencies.
• Contribute to a culture of proactive patient safety within their organization.

Organizational Benefits

• Reduces the risk of non-compliance, costly fines, and legal penalties by ensuring adherence to current global and local regulations.
• Proactive and effective pharmacovigilance practices lead to better patient outcomes and strengthen the company's reputation and public trust.
• Optimizes internal PV processes, from case processing and signal detection to report generation, leading to increased productivity and resource allocation.
• Equips the team with the knowledge and confidence to handle regulatory inspections and audits successfully, ensuring smooth operations and minimal disruption.
• Provides valuable professional development, making the organization more attractive to top-tier talent and fostering a skilled, knowledgeable workforce.
• Enables the timely identification and mitigation of safety risks, protecting the organization from potential product recalls, market withdrawal, and litigation.

Target Audience

• Pharmacovigilance (PV) professionals seeking to advance their careers.
• Drug Safety and Clinical Research Associates (CRAs).
• Qualified Persons for Pharmacovigilance (QPPVs) and aspiring QPPVs.
• Regulatory Affairs professionals involved in post-marketing activities.
• Medical Affairs and Medical Information specialists.
• Auditors and Quality Assurance (QA) personnel in the pharmaceutical industry.
• Heads of drug safety departments.
• Medical writers and clinical data managers.

Course Modules

Module 1: The Evolving GVP Landscape

• Regulatory Evolution: A historical overview and recent updates to key GVP modules
• Global Harmonization: Understanding the role of ICH guidelines and the interplay between EMA, FDA, and WHO regulations.
• GVP Principles: A deep dive into core principles, including quality systems, roles, and responsibilities.
• Case Study: The impact of a recent regulatory change on a large pharmaceutical company's PV system.
• Emerging Trends: The influence of digital health technologies and real-world evidence on pharmacovigilance.

Module 2: Advanced Signal Management

• Signal Detection Methods: Exploring qualitative and quantitative methods, including data mining and statistical analysis.
• Signal Validation & Prioritization: Techniques for validating signals and prioritizing them based on scientific and regulatory criteria.
• Signal Assessment: In-depth analysis of a validated signal, including causality assessment and risk communication.
• Case Study: A detailed analysis of a new signal identified in a post-marketing drug and the subsequent steps taken.
• EudraVigilance & MedDRA: Practical application of EudraVigilance data and the latest version of the Medical Dictionary for Regulatory Activities (MedDRA).

Module 3: Risk Management Planning (RMP)

• RMP Structure: A detailed breakdown of the components of a comprehensive RMP, including the safety specification and pharmacovigilance plan.
• Risk Minimization: Developing and implementing effective risk minimization measures.
• RMP Submission: Navigating the regulatory requirements for RMP submission and updates.
• Case Study: Creating a mock RMP for a new drug, including the selection of appropriate risk minimization strategies.
• REMS and EU GVP: Comparing and contrasting the FDA's REMS with the EU's RMP framework.

Module 4: The Pharmacovigilance System Master File (PSMF)

• PSMF Content: A meticulous review of the required sections and annexes of the PSMF.
• PSMF Maintenance: Best practices for maintaining and updating the PSMF to ensure it is always current and inspection-ready.
• PSMF Quality Control: Implementing a robust quality system for the PSMF, including change control.
• Case Study: Identifying and rectifying deficiencies in an organization's existing PSMF during a simulated audit.
• Global PSMFs: Addressing the complexities of maintaining PSMFs in different regions.

Module 5: Pharmacovigilance Audits and Inspections

• Audit Planning: A risk-based approach to planning internal and external PV audits.
• Inspection Readiness: Strategies for preparing for and successfully managing a regulatory inspection.
• Inspection Follow-up: Developing and implementing robust Corrective and Preventive Action (CAPA) plans for audit findings.
• Case Study: A mock inspection role-play, including an opening meeting, documentation review, and closing meeting.
• Common Findings: An analysis of the most frequent findings from recent regulatory inspections.

Module 6: Aggregate Reporting

• PSURs & PBRERs: In-depth training on the preparation, content, and submission of Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs).
• DSURs: Understanding the specific requirements for Development Safety Update Reports (DSURs) for drugs in development.
• Reporting Timelines: Mastering the complex timelines for different types of aggregate reports.
• Case Study: Compiling a complete PBRER for a product with a complex safety profile, including the benefit-risk assessment section.
• Data Aggregation: Best practices for data extraction and aggregation from a safety database for reporting purposes.

Module 7: Pharmacovigilance Quality Management Systems (QMS)

• QMS Framework: Designing and implementing a robust QMS for pharmacovigilance.
• Quality Objectives & KPIs: Setting measurable quality objectives and key performance indicators (KPIs) for PV activities.
• Deviation Management: Handling deviations and non-conformances within the PV QMS.
• Case Study: Developing a QMS for a new, small-scale PV department.
• Quality Audits: Performing internal quality audits to ensure the QMS is effective and compliant.

Module 8: The Qualified Person for Pharmacovigilance (QPPV)

• QPPV Responsibilities: A comprehensive overview of the roles and responsibilities of the QPPV and their deputy.
• EU and UK QPPV: Understanding the specific requirements and legal obligations in the European Union and the United Kingdom.
• QPPV Oversight: How to effectively oversee a pharmacovigilance system and delegate responsibilities.
• Case Study: A mock crisis scenario where the QPPV must respond to an urgent safety issue.
• PSMF & QPPV: The critical link between the QPPV and the PSMF.

Module 9: Pharmacovigilance in Clinical Trials

• Safety Reporting: Mastering the reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) and other safety events during clinical trials.
• Trial Protocols: Reviewing clinical trial protocols for adequate safety reporting provisions.
• Safety Data Exchange Agreements: Understanding and managing agreements between study sponsors and contract research organizations (CROs).
• Case Study: Managing safety data for a multi-center, global clinical trial.
• eTMF and PV: The role of the electronic Trial Master File (eTMF) in pharmacovigilance.

Module 10: Pharmacovigilance and Artificial Intelligence (AI)

• AI in PV: An introduction to the application of machine learning and natural language processing in pharmacovigilance.
• Automated Case Processing: Exploring how AI can automate case intake, triage, and data entry.
• Signal Detection with AI: The use of AI algorithms for enhanced and more rapid signal detection.
• Case Study: Evaluating the implementation of an AI-powered tool for duplicate detection.
• Ethical Considerations: Addressing the ethical and regulatory challenges of using AI in drug safety.

Module 11: Special PV Situations

• Vaccine Pharmacovigilance: The unique challenges and reporting requirements for vaccine safety.
• Medical Device Vigilance: An overview of the principles of vigilance for medical devices and combination products.
• Pharmacovigilance in Crisis: Strategies for managing PV during public health emergencies.
• Case Study: Analyzing a public health crisis triggered by a new vaccine.
• Special Populations: The nuances of PV in pediatric and geriatric populations.

Module 12: Communication and Risk Communication

• Regulatory Communication: Best practices for communicating with regulatory authorities.
• Patient & HCP Communication: Developing effective risk communication strategies for patients and healthcare professionals.
• Media & Public Relations: Managing media inquiries and public relations during a safety crisis.
• Case Study: Drafting a risk communication plan for a product with new safety information.
• Safety Information Updates: The process for updating a drug's Summary of Product Characteristics (SmPC) and other safety information.

Module 13: PV System Oversight and Management

• Resource Management: Effective management of human and technological resources in a PV department.
• Vendor Oversight: Auditing and managing third-party PV service providers and vendors.
• PV Agreements: Developing and maintaining robust PV System Agreements (PVSAs) with partners.
• Case Study: Evaluating a vendor's performance based on quality metrics and KPIs.
• Budgeting for PV: Financial planning and resource allocation for a modern PV department.

Module 14: Data and Documentation Management

• Documentation Standards: Adhering to GVP standards for documentation and record retention.
• Electronic PV Systems: An overview of leading PV databases and their functionalities.
• Data Integrity: Ensuring the integrity, accuracy, and completeness of PV data.
• Case Study: Troubleshooting a data integrity issue in a safety database.
• GCP and GVP Interplay: Understanding the connection between Good Clinical Practice and Good Pharmacovigilance Practice.

Module 15: Final Capstone Project

• Integrated Project: A comprehensive project that integrates knowledge from all modules.
• Scenario-Based Assessment: Participants will be given a complex PV scenario and required to develop a comprehensive action plan.
• Final Presentation: Presenting the project plan to a panel of experts for feedback.
• Q&A Session: A final opportunity to discuss challenges and best practices.
• Certification: Successful completion of the course and capstone project earns the participant a professional certification.

Training Methodology

The training uses a blended learning approach that combines interactive, instructor-led sessions with practical, hands-on activities. Our methodology includes:

• Live virtual or in-person workshops to facilitate real-time discussion and problem-solving.
• Interactive case studies based on real-world pharmacovigilance challenges to apply theoretical knowledge.
• Group exercises and role-playing to simulate real-life scenarios.
• Expert-led presentations with Q&A sessions to provide deep insights and clarify complex topics.
• Access to a comprehensive online learning platform with course materials, supplemental readings, and quizzes for self-paced learning.

Register as a group from 3 participants for a Discount

Send us an email: [email protected] or call +254724527104 

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

 We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to DATASTAT CONSULTANCY LTD account, as indicated in the invoice so as to enable us prepare better for you.