Pharmacovigilance

Features of the PG Certification in Pharmacovigilance Program (PGPvG)

• Course provides in-depth understanding on pharmacovigilance process. Hence, it provides orientation to job related practical aspects of pharmacovigilance.
• Simulation to real life working in pharmacovigilance department. Therefore, it help to enhance the pharmacovigilance strategic decision making.
• Moreover, course provides advanced training on ADR Reporting and Signal Detection Systems, Pharmacoepidemiology, Causality Assessment of Suspected Adverse Drugs Reactions.
• Pharmacovigilance program also provide in depth understanding how to set up a Pharmacovigilance Center in Industry.
• In conclusion, this online training course provides 360 degree learning for effective Management of Pharmacovigilance Data and Risk Management.

Topics of the PG Certification in Pharmacovigilance Program (PGPvG)

Core Concepts

Comprehensive coverage of fundamental pharmacovigilance concepts, including the definition of pharmacovigilance, its importance, and its role in drug safety.

Regulatory Framework

An overview of the regulatory framework governing pharmacovigilance, including international and regional regulations and guidelines (e.g., ICH, FDA, EMA).

Adverse Event Reporting

Detailed guidance on how to collect, document, and report adverse events and adverse drug reactions (ADRs) in compliance with regulatory requirements.

Signal Detection

Training on methods and techniques for identifying potential safety signals from large pharmacovigilance databases, such as disproportionality analysis and data mining.

Risk Assessment

Discussion of risk assessment methodologies and also risk communication strategies to ensure the safe use of medicinal products.

Clinical Trials and Clinical Trial Safety

Information on pharmacovigilance in clinical trials, including safety data collection, monitoring, and reporting during drug development.

Pharmacovigilance Systems

Examination of the components and functioning of pharmacovigilance systems, including the roles of regulatory authorities, pharmaceutical companies, and healthcare professionals.

Case Studies

Practical case studies and real-world examples to illustrate key concepts and challenges in pharmacovigilance.

Drug Safety Database Tools

Hands-on training with pharmacovigilance software and databases commonly used in the industry, such as the WHO Global Individual Case Safety Reports (ICSRs) database, VigiBase.

Quality Assurance and Auditing

Guidance on quality assurance measures, auditing processes, and also inspection readiness to maintain compliance with regulatory standards.

Pharmacovigilance Communication Skills

Training on effective communication and collaboration within pharmacovigilance teams, as well as with healthcare professionals, patients, and regulatory authorities.

Ethical and Legal Considerations for Pharmacovigilance Process

Discussions on the ethical and legal aspects of pharmacovigilance, including patient privacy and consent.

Few of the similar courses

• Pharmacovigilance and Drug Safety 1 Month Advanced Certification course
• US Pharmaceutical and Biopharmaceutical Regulatory Affairs
• Japan Drug Regulatory Affairs
• Drug Registration and Regulation in China
• Drug Discovery and Development to Commercialization
• European Drug Regulatory Affairs
• Drug Registration and Regulation in GCC countries
• UAE Drug Regulation and Registration
• Drug Registration and Regulation in Saudi Arabia
• Middle East Drug Regulatory Affairs

What is pharmacovigilance?

“Pharmacovigilance ” (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem. Hence,  Its aims are to enhance patient care and patient safety and to support public health programmes by providing reliable, balanced information for the effective assessment of the benefit-risk profile of medicines and vaccines.

Is pharmacovigilance and drug safety is same?

In reality Pharmacovigilance is same as drug safety. In addition Drug Safety is a broad term that describes the collection, analysis, monitoring and prevention of adverse effects in drugs and therapies. However, Drug Safety Management is a completely scientific and process-driven within pharmaceutical and biopharmaceutical industry.

What is an adverse event?

The definition of an adverse event is any reaction within a patient’s body caused by a drug or development molecule – a side effect.  A serious adverse event is a life-threatening side effect that causes hospitalization, incapacity, permanent damage or, in extreme cases, the death of a patient. Adverse event reporting is must for all clinical research investigators, even if the side effects are only suspected.

The role of pharmacovigilance is to determine which adverse events cross the line of a drug’s efficacy. In other words, analyzing which side effects are worth the risk to patients compared with how effective they are at treating a disease. For instance, chemotherapy may cause some serious side effects but when faced with life-threatening cancer, these side effects are considered acceptable given the potential to cure a patient. However, if a drug used to cure a headache caused similar side effects, the risk to the patient would be considered too great and the benefit not substantial enough to justify the potential damage.

What is the difference between pharmacovigilance and regulatory affairs working? >> Click here to learn