New Year Offer End Date: 30th April 2024

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Program

Pharmacovigilance for Drug Safety & Efficacy

pharmacovigilance, drug safety, regulatory compliance, adverse drug reactions, signal detection, risk assessment, pharmaceutical industry, students, faculty, academicians, industry professionals, pharmacology, pharmacy, curriculum, teaching methodologies, clinical research, quality assurance, industry standards, beginners, experienced professionals, updates, advancements, networking, knowledge exchange, pharmaceutical sciences.

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MODE
Mode(Online) TYPE
Self Paced LEVEL
Moderate Program Length
4.5 hours

Skills you will gain:

Pharmaceutical Formulation Pharmacokinetics Pharmacovigilance Systems and Processes Pharmacovigilance Inspections Pharmacovigilance Metrics

About Program:

The Overview of Pharmacovigilance relevant to Pharmaceutical Industry Program is a comprehensive and insightful event designed to provide a thorough understanding of pharmacovigilance within the pharmaceutical industry. This program aims to empower professionals by equipping them with the knowledge and tools necessary to navigate the complex landscape of drug safety monitoring and reporting. Participants will delve into the fundamental principles of pharmacovigilance, gaining insights into adverse drug reactions, signal detection, risk assessment, and regulatory requirements.

Aim:

The aim of the Pharmacovigilance for Drug Safety & Efficacy program is to equip participants with the knowledge, skills, and tools necessary to monitor, evaluate, and ensure the safety and efficacy of pharmaceutical products throughout their lifecycle. Through comprehensive training and practical exercises, the program aims to empower healthcare professionals, regulatory authorities, and pharmaceutical industry stakeholders to detect, assess, and mitigate adverse drug reactions, thereby promoting patient safety and optimizing public health outcomes.

Program Objectives:

Understanding the Principles of Pharmacovigilance: To provide participants with a scientific foundation and understanding of the principles that govern pharmacovigilance, including the detection, assessment, and prevention of adverse drug reactions.
Exploring Pharmacovigilance Data Analysis: To introduce participants to the scientific methods and techniques used in analyzing pharmacovigilance data, enabling them to identify safety signals and assess the risks associated with medicinal products.
Examining the Role of Pharmacovigilance in Drug Safety Monitoring: To explore the role of pharmacovigilance in the post-marketing surveillance of drugs, including the systematic collection and analysis of safety data to ensure the ongoing assessment of their safety profile.
Understanding Signal Detection and Management: To familiarize participants with the scientific approaches and methodologies employed in signal detection and management, including the identification, evaluation, and prioritization of potential safety signals.
Assessing Risk-Benefit Profiles: To enable participants to understand the scientific basis of assessing the risk-benefit profiles of medicinal products, considering both the potential benefits and risks associated with their use.
Exploring Pharmacovigilance Regulations and Guidelines: To provide participants with an understanding of the scientific basis underlying pharmacovigilance regulations and guidelines, enabling them to interpret and apply them appropriately in their professional roles.
Investigating Emerging Trends in Pharmacovigilance: To explore the scientific advancements and emerging trends in the field of pharmacovigilance, including the application of artificial intelligence, big data analytics, and real-world evidence in drug safety monitoring.
Analyzing Pharmacovigilance Case Studies: To engage participants in scientific discussions and analysis of pharmacovigilance case studies, allowing them to critically evaluate and apply scientific principles in practical scenarios.
Promoting Scientific Rigor in Reporting and Documentation: To emphasize the importance of accurate and comprehensive scientific reporting and documentation in pharmacovigilance, ensuring the integrity and reliability of safety data.
Encouraging Scientific Collaboration and Research: To foster a scientific culture of collaboration and research in pharmacovigilance, encouraging participants to explore scientific inquiry, contribute to the literature, and engage in evidence-based practices.

What you will learn?

Day 1:
Session 1: Introduction to Pharmacovigilance

● Overview of pharmacovigilance and its significance in the pharmaceutical industry
● Importance of pharmacovigilance in ensuring drug safety and patient welfare
● Regulatory frameworks and guidelines governing pharmacovigilance

Session 2: Adverse Drug Reactions (ADRs)

● Definition and classification of adverse drug reactions
● Identification, assessment, and reporting of ADRs
● Tools and techniques for ADR detection and signal management

Session 3: Pharmacovigilance Databases and Systems

● Introduction to pharmacovigilance databases and their role in data collection and analysis
● Case studies: Analyzing real-world data from pharmacovigilance databases

Session 4: Pharmacovigilance in Clinical Trials

● Role of pharmacovigilance in clinical trial safety monitoring
● Adverse event reporting in clinical trials
● Ethical considerations and patient safety in clinical research

Day 2:

Session 5: Risk Management in Pharmacovigilance

● Overview of risk management strategies in pharmacovigilance
● Risk minimization measures and their implementation
● Pharmacovigilance planning and risk management plans

Session 6: Signal Detection and Management

● Principles of signal detection and signal management
● Tools and methodologies for signal detection and assessment
● Case studies: Analyzing and managing safety signals

Session 7: Pharmacovigilance Audits and Inspections

● Overview of pharmacovigilance audits and inspections
● Preparation and compliance for pharmacovigilance audits
● Ensuring quality and regulatory compliance in pharmacovigilance

Day 3:

Session 8: Pharmacovigilance in Special Populations

● Pharmacovigilance considerations in special populations (pediatrics, geriatrics, pregnant women, etc.)
● Monitoring and reporting adverse events in vulnerable populations
● Case studies: Addressing pharmacovigilance challenges in special populations

Session 9: Pharmacovigilance Communication and Reporting

● Effective communication of drug safety information to healthcare professionals and the public
● Regulatory reporting requirements and timelines
● Practical exercises: Preparing pharmacovigilance reports and communication materials

Session 10: Emerging Trends and Future Directions in Pharmacovigilance

● Latest advancements and technologies in pharmacovigilance
● Digital pharmacovigilance and the role of artificial intelligence
● Discussion on future challenges and opportunities in pharmacovigilance

Fee Plan

INR 1999 /- OR USD 50

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Intended For :

Educational Background: Participants should have a background in pharmacy, medicine, pharmacology, life sciences, or a related field. This ensures that they have the foundational knowledge required to understand pharmacovigilance concepts and principles.
Professional Experience: While not always mandatory, participants with prior experience or employment in healthcare, pharmaceutical industry, regulatory affairs, or drug safety are often preferred. Experience in roles related to drug monitoring, adverse event reporting, or regulatory compliance can be advantageous.
Regulatory Compliance: Participants should be familiar with relevant regulations and guidelines governing pharmacovigilance practices in their respective countries or regions. Knowledge of regulatory frameworks such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines is beneficial.
Computer Skills: Basic computer literacy and proficiency in using software applications for data entry, analysis, and reporting may be required, as pharmacovigilance activities often involve working with electronic databases and reporting systems.
Language Proficiency: Proficiency in the language of instruction (e.g., English) may be necessary to understand lectures, instructions, and training materials effectively, particularly for programs conducted in an international context.
Motivation and Interest: Participants should demonstrate a genuine interest in pharmacovigilance, patient safety, and public health. They should be motivated to learn and apply new concepts and methodologies to enhance drug safety and efficacy monitoring practices.
Access to Resources: Depending on the program format (e.g., online course, in-person training), participants may need access to a computer with internet connectivity to participate in lectures, access course materials, and complete assignments or assessments.
Continuing Education Requirements: Professionals seeking continuing education credits or certifications in pharmacovigilance may need to meet additional eligibility criteria specified by accrediting bodies or regulatory authorities.

, Research Scholars, Industry Professionals of Pharmaceutical Sciences, Pharmacology, Pharmacy, Pharmaceutical Industry

Career Supporting Skills

Pharmacovigilance Documentation Good Pharmacovigilance Practices (GVP) Pharmacovigilance Risk Assessment and Benefit-Risk Analysis Pharmacovigilance Data Analysis Pharmacovigilance Quality Management

Program Outcomes

Proficiency in Pharmacovigilance Data Analysis: Participants will develop scientific skills in analyzing pharmacovigilance data, identifying safety signals, and assessing the risks associated with medicinal products using scientific approaches and statistical methods.
Expertise in Signal Detection and Management: Participants will acquire scientific expertise in detecting, evaluating, and managing safety signals, applying scientific methodologies to prioritize signals and determine appropriate risk mitigation strategies.
Knowledge of Pharmacovigilance Regulations and Guidelines: Participants will gain a scientific understanding of pharmacovigilance regulations and guidelines, allowing them to interpret and apply them in a scientifically rigorous manner.
Ability to Assess Risk-Benefit Profiles: Participants will be able to scientifically assess the risk-benefit profiles of medicinal products, considering scientific evidence and applying scientific principles to evaluate the potential benefits and risks.
Familiarity with Scientific Reporting and Documentation: Participants will develop scientific proficiency in reporting and documenting pharmacovigilance data, ensuring accuracy, reliability, and scientific integrity in their reports and documentation.
Awareness of Emerging Scientific Trends: Participants will stay informed about emerging scientific trends in pharmacovigilance, such as the integration of real-world evidence, big data analytics, and artificial intelligence, enabling them to stay updated with the latest scientific advancements.
Competence in Pharmacovigilance Research: Participants will have the scientific knowledge and skills to engage in pharmacovigilance research, contributing to the scientific literature and advancing knowledge in the field.