Pharmacovigilance Excellence: Compliance and Signal Management Strategies
This three-day workshop equips participants with essential skills in pharmacovigilance, focusing on signal detection, validation, and management. It covers key principles, data analysis techniques, and tools for evaluating drug safety signals. Participants will engage in hands-on exercises, including disproportionality analysis and ICSR data entry, while learning strategies for effective stakeholder communication and compliance in signal management.
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Online
Mentor Based
Moderate
3 Days (1.5 Hours/ Day)
26-Mar-2025
3:00 PM IST
About
Pharmacovigilance Excellence: Compliance and Signal Management Strategies is a specialized training program designed for professionals in the pharmaceutical, healthcare, and IT sectors. This workshop focuses on equipping participants with the knowledge and practical skills needed to effectively detect, validate, and manage drug safety signals. Over three days, participants will gain a deep understanding of pharmacovigilance principles, signal detection methods, and risk management strategies. The program includes hands-on exercises, interactive discussions, and advanced data analytics techniques, ensuring a thorough grasp of both the compliance and non-technical IT aspects of pharmacovigilance. This workshop is ideal for those seeking to enhance their expertise in signal detection, evaluation, and management in the context of patient safety.
Aim
The aim of this workshop is to provide participants with a comprehensive understanding of pharmacovigilance principles, focusing on the detection, validation, evaluation, and management of drug safety signals. Through a combination of theoretical insights and practical exercises, the workshop seeks to enhance participants’ ability to apply signal detection tools, perform data analysis, and communicate findings effectively to stakeholders. The program also aims to equip professionals with the necessary skills to ensure compliance with regulatory requirements and improve the management of drug safety risks using non-technical IT solutions.
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Workshop Objectives
- Understand Pharmacovigilance Fundamentals:
Gain a solid understanding of pharmacovigilance principles and their importance in ensuring patient safety. - Learn Signal Detection Techniques:
Explore various methods and tools used for detecting drug safety signals from different data sources. - Master Signal Validation and Evaluation:
Learn the criteria for signal validation and how to evaluate signals once they are confirmed. - Develop Practical Data Analysis Skills:
Gain hands-on experience in analyzing safety data, including disproportionality analysis and signal detection from public domain databases. - Enhance Risk Management Skills:
Understand the processes for managing risks associated with confirmed signals and the role of risk management plans. - Strengthen Stakeholder Communication:
Learn strategies for effectively communicating signal findings and risk management strategies to stakeholders. - Prepare for Compliance in Pharmacovigilance:
Equip participants with the knowledge to ensure compliance with regulatory requirements in signal detection and management.
Workshop Structure
Day 1: Introduction to Pharmacovigilance and Signal Detection
- Session 1: Overview of Pharmacovigilance
- Definition and importance of pharmacovigilance.
- Key principles and the role of signal detection in patient safety.
- Session 2: Fundamentals of Signal Detection
- Types of data sources for signal detection.
- Methods and tools used in the identification of signals.
Day 2: Signal Validation and Evaluation
- Session 1: Signal Validation and Evaluation
- Criteria for signal validation.
- If validated, criteria for evaluation.
- Session 2: Hands-On training on analysis of data from different sources. For e.g.:
- Search safety signals from Health authority websites.
- Literature search criteria, how to prepare search strategies.
- Different database review (available for public domain). For e.g EVDAS.
- Disproportionality analysis.
Day 3: Signal Management and Communication to stakeholders
- Session 1: Managing Identified Signals
- Procedures for managing risks associated with confirmed signals.
- Role of risk management plans.
Skill-Building Workshop: Advanced Data Analytics for Signal Management
- Interactive Practical Exercise:
- A live interactive exercise where participants will work on a dataset to detect signals, followed by group discussions to review their findings.
- Data entry for cases received from client (ICSR)
Participant’s Eligibility
- Pharmacovigilance Professionals:
Individuals working in pharmacovigilance, drug safety, or regulatory affairs who want to deepen their knowledge and skills. - Data Analysts and Biostatisticians:
Professionals involved in data analysis and interpretation, particularly in the context of healthcare and pharmaceutical industries. - Healthcare and Clinical Research Professionals:
Doctors, nurses, and researchers working in clinical trials, patient safety, or related fields. - IT Professionals:
Non-technical IT professionals who support pharmacovigilance and signal detection systems. - Regulatory Affairs and Compliance Officers:
Those responsible for ensuring compliance with global drug safety regulations. - Graduates and Postgraduates:
Individuals with a background in pharmacy, life sciences, healthcare, or IT, looking to enter the field of pharmacovigilance.
Workshop Outcomes
- Enhanced Understanding of Pharmacovigilance:
Participants will gain a comprehensive understanding of pharmacovigilance principles, including the role of signal detection in ensuring patient safety. - Proficiency in Signal Detection and Evaluation:
Participants will be able to effectively detect and evaluate drug safety signals using various methods and data sources, including disproportionality analysis. - Practical Data Analysis Skills:
Participants will develop hands-on experience with advanced data analytics tools and techniques, applying them to real-world datasets for signal detection and management. - Improved Risk Management Capabilities:
Participants will learn how to manage confirmed drug safety signals and implement effective risk management plans to mitigate risks to patient safety. - Effective Stakeholder Communication:
Participants will acquire the skills to communicate signal findings and risk management strategies clearly and effectively to various stakeholders. - Compliance with Regulatory Standards:
Participants will be equipped to navigate the compliance landscape of pharmacovigilance, ensuring adherence to global regulations and best practices. - Confidence in Handling Real-World Data:
By working on real datasets and case studies, participants will be better prepared to handle and analyze pharmacovigilance data in their respective roles.
Mentor Profile
Name :Rohit Singhal
Designation :Sr. Safety Manager
Affiliation :IQVIA
Dr. Rohit Singhal is currently working as a Sr. Safety Manager, Global Pharmacovigilance (Signal Management), IQVIA for more than 9 years. Dr. Rohit comes with over 20 years of industry experience including Marketing, Teaching, Clinical Research, Regulatory, Medical Service and Pharmacovigilance. Dr. Rohit had worked with companies of repute like Cipla, Torrent, Lupin. Dr. Rohit attended and presented the various research papers in National and International conferences/workshops. Additionally, Dr. Rohit has delivered guest lecturers on various topics of Clinical Research and Pharmacovigilance and in addition to this he have multiple research papers published in National and International Journals to his credit on the same subjects. He has been invited in various colleges/universities/conferences/workshops to deliver a lecture. Dr. Rohit holds a Master’s degree with specialization in Clinical Pharmacy (Pharmacy Practice) and Doctorate in Pharmacovigilance under supervision of Prof. (Dr.) D D Santani. Recently Dr. Rohit has completed his MBA.
Fee Structure
Student
INR. 1699 | USD. 60
Ph.D. / Researcher
INR. 1999 | USD. 65
Academician
INR. 2199 | USD. 75
Industry Professional
INR. 2699 | USD. 95
Certificate
- Access to Live Lectures
- Access to Recorded Sessions
- e-Certificate
- Query Solving Post Workshop
Future Career Prospects
- Specialized Pharmacovigilance Roles:
- Pharmacovigilance Manager
- Signal Detection Expert
- Drug Safety Director
- Global Career Opportunities:
- International roles in pharmaceutical companies, CROs, and regulatory agencies (FDA, EMA, WHO)
- Career Path in Clinical Research and Data Analytics:
- Clinical Data Scientist
- Pharmacovigilance Data Analyst
- Risk Management and Regulatory Affairs Leadership:
- Risk Management Head
- Regulatory Affairs Manager
- Compliance Director
- Consulting and Independent Practice:
- Pharmacovigilance Consultant
- Regulatory Affairs Consultant
- Academia and Research:
- University Professor or Researcher in Pharmacovigilance
- Research roles in regulatory bodies or healthcare research institutes
- Technological Advancements and IT Roles in Pharmacovigilance:
- Pharmacovigilance IT Specialist
- AI Drug Safety Expert
- Pharmaceutical Systems Analyst
- Regulatory Leadership in Global Organizations:
- Leadership roles in international pharmaceutical and regulatory bodies
- Shaping public health policies and global safety standards
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Job Opportunities
- Pharmacovigilance Officer/Associate:
Monitor and report adverse drug reactions (ADRs), conduct signal detection and analysis, and ensure compliance with regulatory requirements. - Signal Detection Specialist:
Analyze healthcare data to identify potential safety signals, assess their significance, and support risk management processes. - Drug Safety Analyst:
Use statistical tools to analyze safety data, including disproportionality analysis, and ensure timely reporting of safety signals to regulatory authorities. - Clinical Research Associate (CRA):
Work on clinical trials to ensure patient safety and manage adverse event reporting. - Regulatory Affairs Specialist:
Focus on ensuring that drug safety practices comply with national and international regulatory standards, contributing to the development of risk management plans. - Data Scientist/Analyst in Healthcare or Pharmaceuticals:
Use data analytics tools and techniques to detect, validate, and manage safety signals from various healthcare and pharmaceutical datasets. - Risk Management Specialist:
Develop and implement risk management strategies for identified drug safety signals, ensuring patient safety and compliance with regulations. - Compliance Officer (Pharmaceuticals):
Ensure that pharmacovigilance activities meet local and international regulatory requirements, preparing reports for regulatory bodies. - Medical Writer in Pharmacovigilance:
Prepare documentation, including safety reports, regulatory submissions, and risk management plans, related to drug safety and pharmacovigilance. - Health IT Specialist for Pharmacovigilance Systems:
Support the implementation and maintenance of IT systems used for signal detection, data analysis, and reporting in pharmacovigilance.
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