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Drug Safety Course & Certification
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4 hours
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About
Pharmacovigilance (Drug Safety) is the science and practice of detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. It plays a critical role in ensuring patient safety and maintaining the benefit–risk balance of medicinal products throughout their lifecycle.
This Pharmacovigilance – Drug Safety Course & Certification provides a comprehensive introduction to pharmacovigilance systems, adverse event reporting, regulatory requirements, and safety assessment processes. The course covers the history and evolution of drug safety, key definitions and terminology, clinical and post-marketing safety monitoring, causality assessment, reporting timelines, and regulatory submission formats. Upon completion, learners receive a certification demonstrating their understanding of global pharmacovigilance principles and practices.
Who Should Enrol ?:
- Pharmacovigilance and Drug Safety Associates
- Clinical Research Professionals (CRAs, CRCs, CTMs)
- Medical and Healthcare Professionals
- Regulatory Affairs Personnel
- Pharmaceutical and Biotechnology Industry Employees
- Quality Assurance and Clinical Data Professionals
- Medical Coders and Case Processing Staff
- Life Science, Pharmacy, and Medical Graduates
- Anyone seeking a career or certification in drug safety
What you will learn
Understand the fundamentals of pharmacovigilance, its historical development, and the importance of adverse event monitoring in drug safety.
Learn the differences between clinical and post-marketing adverse events, including adverse drug reactions (ADRs), SAEs, and SUSARs.
Develop knowledge of adverse event assessment, causality evaluation, seriousness criteria, reporting requirements, and regulatory timelines.
Gain understanding of pharmacovigilance reporting processes, safety documentation, aggregate reports, PSUR/PBRER reporting, and management of blinded therapy cases.
Course Syllabus
- Learning Objectives for This Module
- What Is Pharmacovigilance?
- Thalidomide 1957–1961
- Thalidomide’s Impact on Regulations
- History of Pharmacovigilance, 1962–2000
- History of Pharmacovigilance, 2000–Present Day
- Pre-Marketed AEs
- Limitations of Pre-Approval Clinical Trials
- Likelihood of Observing ADRs in Patients Usually Studied in Clinical Trials
- Post-Marketed AEs
- Pre- and Post-Marketing: Basic Differences
- The Importance of Adverse Event Reporting
- Reasons for Adverse Event Collection & Reporting
- Pharmacovigilance Definitions
- Acronyms Used in This Training Session
- ICH Definition of Adverse Event
- Examples of Adverse Events
- Examples of Adverse Events II
- ICH Definition of Adverse Drug Reaction – Clinical
- ICH Definition of Adverse Drug Reaction – Post-Marketing
- Suspected Unexpected Serious Adverse Reaction
- Sources of ADRs
- Pharmacovigilance Process
- Assessing Adverse Events
- Regulatory Definition of a Serious Adverse Event
- Seriousness: Life-Threatening
- Examples of Life-Threatening Adverse Events I
- Examples of Life-Threatening Adverse Events II
- Seriousness: Disability
- Seriousness: Medically Significant Events I
- Seriousness: Medically Significant Events II
- Intensity
- Intensity II
- Difficulty Assessing Relationship of AEs With Drug
- Causality
- Causality II
- Definitely Related
- Probably Related
- Possibly Related
- Unlikely to Be Related
- Relationship Testing
- Lack of Efficacy – ICH I
- Lack of Efficacy – ICH II
- Special Situations I
- Special Situations II – Death
- Special Situations III – Medical Error
- Expectedness
- Labeled vs. Listed
- General Types of Reports
- Expedited Reporting – What to Report I
- Expedited Reporting – What to Report II
- Expedited Reporting – What Not to Report
- Reporting Timeframes for ICSRs
- Reporting Timeframes for ICSRs (Continued)
- Reporting to IRB/ECs
- Investigator Notification
- Minimum Criteria for Reporting
- Minimum Data Set Day 0
- Reporting Format I
- Reporting Format II
- CIOMS Report
- FDA 3500A Report (“MedWatch” Report)
- Key Data Elements for Inclusion in Expedited Reports
- Aggregate Reports
- PSUR Reporting
- PSUR/PBRER
- PSUR Periodicity, Non-EU
- PSUR Periodicity, EU
- Managing Blinded Therapy Cases
- Managing Blinded Therapy Cases II
- Managing Blinded Therapy Cases III
- Adverse Reaction Types
- 📘 Bonus: Pharmacovigilance Drug Safety eBook (Free with purchase)
Course Benefits
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with any legislative changes in pharmacovigilance as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed to ensure that you comply with pharmacovigilance legislation through the application of learning outcomes. The course is written by Steve Jolley, who is a chairperson for the Drug Information Association (DIA)
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