Triage Definition: The Ultimate Guide to Understanding The Meaning of Triage (Definition & Practices) - 2025 Edition
Triage is a term that resonates across multiple disciplines, from healthcare and emergency management to business strategy and IT systems. But what exactly does it mean, and why is it so important in critical decision-making? This guide unpacks the definition of triage, highlights its applications, and explores its relevance through engaging examples and actionable insights.
This structured and engaging guide includes 3 resourceful tables and practical strategies to help you master the concept of triage—whether you're a healthcare professional, project manager, or business leader.
What Is Triage?
At its core, triage is the process of prioritizing tasks, resources, or individuals based on the urgency and severity of need. Derived from the French word trier, meaning "to sort," triage is fundamentally a system for effective decision-making during resource scarcity or high-stakes scenarios.
The Three Pillars of Triage
Prioritization: Deciding which cases or tasks are the most urgent.
Resource Allocation: Determining how to efficiently use limited tools, personnel, or time.
Continuous Evaluation: Reassessing priorities as conditions evolve.
Triage ensures that the most pressing needs are addressed first, ultimately limiting risk and achieving optimal outcomes.
Triage in Various Fields
Triage is a universal concept, extending beyond healthcare to encompass fields like emergency management, IT troubleshooting, and business. Here’s how triage works in different sectors:
How Triage Works in Healthcare
The Three-Category Triage System
Healthcare professionals use triage primarily to prioritize patients in emergency care or disaster settings. Here is a breakdown of the commonly employed three-category triage system:
Immediate (Red): Critical cases requiring life-saving interventions (e.g., cardiac arrest).
Delayed (Yellow): Serious but not life-threatening; treatment can be postponed slightly (e.g., fractures).
Minor (Green): Non-urgent cases requiring basic treatment or observation (e.g., minor cuts).
Table 2. Healthcare Triage Categories
This structured categorization allows medics to focus care where it is most needed.
Actionable Tips for Triage Application
The effectiveness of any triage system depends on striking the right balance between urgency, resource capability, and outcomes. Follow these actionable steps to optimize the triage process.
Steps for Effective Triage
Establish Clear Criteria: Define what qualifies as high, moderate, and low priority. Use objective measures to prevent bias.
Integrate Technology: Tools like resource management software or automated alert systems improve efficiency and trackability.
Train Your Team: Conduct simulations to prepare staff for high-pressure decision-making scenarios.
Transitioning Your Skills to Work in Clinical Research
If you’re working in a field that relies on triage—such as healthcare, project management, or IT—you already possess valuable skills for transitioning into clinical research. Here’s how to leverage your existing expertise to build a career in this growing industry.
Why Clinical Research?
Clinical research plays a vital role in advancing medicine, and it requires professionals with exceptional organizational, analytical, and problem-solving skills. Transitioning into clinical research offers the chance to blend competitive salaries with meaningful contributions to healthcare innovation.
Key Transferable Skills
You might not realize it, but common triage-related skills are highly valuable for clinical research roles like Clinical Research Associates (CRA), Data Managers, or Regulatory Specialists.
Transition to Clinical Trials
Actionable Steps to Transition
Gain Certification: Get certified through programs like CCRPS to gain credibility and foundational knowledge. Certification not only provides the necessary competencies but also ensures regulatory readiness for clinical trials.
Highlight Your Experience: On your resume, emphasize how skills like prioritization and resource allocation from your current role are directly applicable to trial monitoring and patient safety.
Network Effectively: Join clinical research communities or forums to connect with professionals, access opportunities, and learn the industry's nuances.
Assess Your Readiness: Take the CCRPS Certification Quiz to determine how ready you are to step into clinical research and identify areas of improvement.
Take Free CCRPS Career Quiz Today
The Meaning of Triage: Triage in Pharmacovigilance and Clinical Research
Triage in Clinical Research
Clinical research is a dynamic field where new findings shape future healthcare innovations. While “triage” might recall an emergency room setting, it also plays a critical role in research management. Triage in clinical research is essential for prioritizing the enrollment of participants, optimizing resources, and driving impactful results. This guide unpacks the meaning of triage, its applications in clinical trials, and actionable strategies to ensure impactful collaboration and outcomes.
For professionals looking to expand their clinical research expertise, this guide also provides direct links to certifications and training programs to propel your career forward on platforms like app.ccrps.org.
What Is Triage in Clinical Research?
Modern clinical research adopts triage as a systematic sorting process, where potential participants or trial aspects are assessed and prioritized based on urgency, eligibility, and trial objectives. This mirrors medical triage’s goal of addressing critical needs first but adapts it to focus more on enrollment and decision-making efficiency within the research ecosystem.
Key Goals in Clinical Research Triage
Efficient Participant Selection: Identifying individuals who meet specific eligibility criteria ensures resources aren't wasted, and trials proceed smoothly. To improve your expertise in this area, check out the Clinical Research Coordinator Course.
Maximizing Trial Success: Prioritizing optimal matches between participants and trial objectives improves meaningful outcomes. Learn more about best practices for maintaining trial safety in the Pharmacovigilance Certification.
Triage Steps in Clinical Trials
Step 1. Determine Eligibility
Eligibility serves as the foundation of clinical research triage. Factors such as diagnosis, age, medical history, and treatment status are scrutinized to align participant profiles with trial goals.
Screening Tools: Digital systems like EHRs (Electronic Health Records) streamline identifying eligible participants.
Certification Opportunity: Discover how Clinical Trials Assistant professionals handle eligibility processes through specialized training.
Step 2. Patient Randomization
Eligible participants are divided into treatment and control groups. This step ensures impartiality and strengthens the trial's scientific validity.
Tip: Deepen your understanding of controlled environments in trials by earning the ICH-GCP Certification.
Step 3. Safety and Monitoring
Participants undergo regular monitoring for adverse events (AEs) while researchers evaluate the safety profile of investigational drugs or devices.
Learn More: Improve skills in monitoring trial safety by exploring the Medical Monitor Certification.
Step 4. Final Evaluation
The trial’s success depends on assessing whether the treatment significantly improved outcomes compared to the control.
Benefits of Triage for Researchers and Patients
Triage provides multifaceted advantages that improve process efficiency while delivering positive patient outcomes.
For Researchers
Streamlined Resource Use: Triage ensures researchers allocate time, patient slots, and funding to maximize trial impact.
Improved Collaboration: An organized triage process fosters teamwork among coordinators, regulatory officers, and medical monitors. Interested in facilitating better collaboration? Check out the Advanced Research Project Manager Certification.
For Patients
Priority Access: Patients most in need of treatment are enrolled first, ensuring they benefit from cutting-edge therapies.
Customized Care: Through rigorous selection and follow-ups, patients receive care personalized to their conditions.
Tips for Effective Triage in Pharmacovigilance
Triage also plays a critical role in post-market surveillance and pharmacovigilance. Here are actionable tips for clinical research professionals responsible for monitoring drug safety.
Categorize Potential Risks: Use a risk matrix to prioritize adverse drug events (ADEs) by severity, likelihood, and population impact.
Utilize Alert Systems: Automate and centralize reporting systems for ADEs to identify safety trends faster. Access tools with the Pharmacovigilance Certification.
Continual Training: Equip all team members with up-to-date training on drug safety monitoring. Explore options through ICH-GCP Certification.
Beyond Proficiency—The Importance of Collaboration
Knowing the nuances of triage is only half the equation. To truly excel, professionals must master collaboration across clinical teams. From physicians and nurses to data managers, ensuring consistent communication and shared understanding is critical for seamless trial execution.
Recommended Certification
Enhance collaboration skills by exploring the Clinical Research Associate (CRA) Course.
Empower Your Clinical Research Journey
Triage stands as the backbone of clinical trials, providing structure to participant selection, resource allocation, and adverse event management. For ambitious professionals aiming for leadership roles or specialized skills, certifications on app.ccrps.org offer the perfect stepping stone into advanced career opportunities.
Key Certifications to Accelerate Your Growth:
Clinical Trials Assistant Training: Ideal for support roles in trial execution.
ICH-GCP Certification: Gain comprehensive knowledge of international clinical trial guidelines.
Advanced Principal Investigator Physician Certification: Tailored for medical professionals aspiring to lead trials.
By mastering the art of clinical triage, you'll help shape the future of medicine—one trial at a time. Begin your transformational career today by exploring all the available programs and quizzes at app.ccrps.org.
The Steps of Triage in Clinical Trials
Triage in clinical trials is a structured process that ensures the efficient use of resources, while keeping patient safety and trial success at the forefront. Here is a step-by-step look at how triage functions in this context:
1. Determine Eligibility
The first and most critical step in clinical trial triage is establishing eligibility. Researchers evaluate participants based on specific criteria such as age, medical history, condition severity, and treatment status. These factors ensure that only individuals who align with the trial’s objectives are enrolled.
Why It Matters: Screening participants saves time and prevents resources from being spent on ineligible cases. It helps trials stay focused and efficient.
Tools & Training: Many trials now incorporate Electronic Health Records (EHRs) to verify eligibility. Explore more about trial coordination with the Clinical Research Coordinator Course.
2. Safety Assessment
The next step involves continuous monitoring of trial participants to safeguard their health. Researchers look for potential adverse events (AEs) or any sign of harm stemming from the investigational drug or treatment.
Action Plan:
Serious adverse events result in immediate suspension of treatment for the affected participant.
Medical care is provided promptly to address any observed risks.
Reliable safety assessment not only protects participants but also prevents regulatory issues that could halt the trial. Build expertise in safety monitoring through the Medical Monitor Certification.
3. Evaluate Efficacy
Finally, researchers assess how well the drug or treatment worked compared to placebo or standard care. This step determines whether the treatment has achieved its intended goals with minimal side effects.
Outcome: If the data points to safety and success, the treatment may move one step closer to regulatory approval.
Building Efficiency with Triage
Triage in clinical trials ensures that each phase—eligibility, safety, and efficacy—is properly executed. For those aspiring to play a pivotal role in carrying out these steps, the ICH-GCP Certification provides valuable insights into global clinical trial standards.
How Triage Prioritizes Patients in Clinical Research
Prioritizing patients in clinical research is both an art and a science. By sorting participants based on their level of need and suitability for the study, triage allows researchers to focus on the individuals most likely to benefit from treatment—and, in turn, contribute to meaningful outcomes. Here’s what that process looks like in detail:
Factors That Influence Triage Decisions
Severity of Illness: Patients with life-threatening or advanced conditions often get priority in trials designed for urgent interventions.
Resource Availability: Trials have limited resources, from study slots to medical staff, requiring careful prioritization to maximize efficiency.
Study Type: Some trials are intentionally designed to recruit only the most severe or uncommon cases.
Existing Patient Data: Patients with prior records of similar treatment can be excluded to avoid redundancy.
Key Insight: Those patients deemed high-risk or ineligible are excluded not to deny them care, but to ensure their safety, as some treatments could amplify risks.
Benefits of Triage in Clinical Trials
Triage brings substantial benefits for both researchers and patients, fostering an environment of streamlined operation and improved outcomes.
For Researchers
Efficient Resource Management: Triage ensures that time, funding, and personnel are used where they will make the greatest impact.
Faster Data Collection: By enrolling the most eligible patients, researchers gather higher quality data in a shorter time span.
Enhanced Collaboration: Clinical staff, data scientists, and regulators work seamlessly when decision-making is guided by triage principles.
Learn More: Build your collaborative skills with the CRA Course.
For Patients
Priority Access to Treatment: Patients with critical needs gain timely inclusion in trials offering life-changing therapies.
Personalized Care: Researchers ensure each patient receives the care that aligns best with their condition.
Improved Health Outcomes: Triage helps patients participate in well-structured trials with strong safety protocols.
Tips for Effective Clinical Triage in Pharmacovigilance
Efficient triage in clinical trials doesn’t end at enrollment. It extends into pharmacovigilance—monitoring the safety profile of new and approved drugs. Here are some key strategies to optimize triage in this critical phase:
1. Rank Adverse Events by Severity
Categorize potential adverse events (ADEs) based on their seriousness, likelihood, and population impact. Focus on the most urgent cases first.
2. Automate Reporting Systems
Use centralized digital platforms to flag ADE trends. Early detection prevents risks from escalating.
3. Promote Continued Training
Equip every team member with up-to-date training in pharmacovigilance to maintain a seamless workflow. Check out the Pharmacovigilance Certification to enhance your readiness.
Why Triage Matters
Triage isn’t just a method—it’s a philosophy guiding better decision-making in clinical research. By optimizing participant selection, ensuring safety, and fostering collaboration, triage enhances not just the quality of trials but also the lives of those they touch.
Whether you’re looking to extend your clinical research skills or refine your expertise in pharmacovigilance, now is the time to act. Gain certifications that align with your career goals by visiting app.ccrps.org today
Pharmacovigilance: A Complete Guide to Pharmacovigilance and Drug Safety Training
What Is Pharmacovigilance? - Definition, Jobs, Salary, And Pharmacovigilance Certification
Pharmacovigilance
A Guide All About Pharmacovigilance
To increase your chances of getting hired or promoted, scroll below or enroll in our CCRPS Advanced Pharmacovigilance and Argus Safety Certification (APVASC)TM Course which covers drug safety and pharmacovigilance training
What is pharmacovigilance?
Pharmacovigilance Is The Study Of Two Primary Outcomes In The Pharmaceutical Industry:
Safety And Efficacy.
Essentially, it asks does a drug work and is it safe?
Pharmacovigilance is the process of monitoring the effects of drugs, both new and existing ones. This includes collecting data, analyzing it, and taking steps to prevent any negative effects. Pharmacovigilance must happen throughout the entire life cycle of a drug, from when it is first being developed to long after it has been released on the market.
What is the Aim Of Pharmacovigilance?
Pharmacovigilance is required through the entire life cycle of a drug – starting at the preclinical development stage and going right through to continued monitoring of drugs once they hit the market.
Pharmacovigilance includes collecting, analyzing, monitoring, and preventing adverse effects in new drugs and therapies.
It can be broken down into three main sub-specialisms:
Surveillance: Surveillance is geared towards risk management and signal detection. Roles in this specialism focus analysis of drug safety information gathered from other professionals. Surveillance is responsible for creating development safety update reports (DSURs) for drugs in clinical research and periodic benefit-risk evaluation reports (PBRER) for drugs that are on the market.
Operations: Operations focus on collecting and recording information during preclinical development, early clinical trials, and gathering real-world evidence (RWE) of adverse events reported by medical professionals and patients. Operations may also create standard operating procedures (SOPs), individual case study reports, and regulatory reports.
Systems: Systems is concerned with the development of robust systems to store and manage data relating to pharmacovigilance. It involves keeping abreast of changing regulations and guidance in the pharmacovigilance industry and ensuring compliance at all levels of an organization.
The Qualified Person for Pharmacovigilance (QPPV) is responsible for ensuring that an organization's pharmacovigilance system meets all applicable requirements.
What is Pharmacovigilance Training?
If you’re looking to boost your career prospects in the pharmaceutical industry, drug safety training is a great string to add to your bow. Whether you want to move into clinical research or enhance your profile in your existing company, certification is crucial.
If you run a company and want to provide your staff with drug safety training to increase their knowledge and provide a safer working environment, our course is for you too.
We even help train Senior PVs from Fortune 500 companies to improve their efficiency and compliance.
No experience? No worries!
Our triple-accredited Advanced Pharmacovigilance and Argus Safety Certification (APVASC)TM is designed to teach you all you need to know in just 1 week!
Recognized Drug Safety Training I 180 Hours I On-Demand I Accredited I 25+ Modules I Training Compliance I Instant Enrolment I 1+Wk Certification I
What do Pharmacovigilance Officers do?
The exact nature of each role varies, but in essence, Pharmacovigilance Officers (PVs) collect adverse event data on drugs (Phase 4) to analyse and create usage warnings for the drug.
Some roles insist on physicians, nurses, or those with a Master of Science degree. A Master’s in pharmacovigilance is your best route into the industry – but that takes up to 2 years and is very expensive.
Your quicker route into the industry is with a drug safety accreditation.
Please note: A minimum of an associate degree is required to take any training course, including ours.
How To Get Into Pharmacovigilance
The CCRPS pharmacovigilance certification to provide advanced training for entry level pharmacovigilance to ensure you are fully prepared for a career in drug safety monitoring. We are a non-profit organization dedicated to providing advanced pharmacovigilance training to students at all stages of their careers.
The courses provide you with theory and practical-based learning in pharmacovigilance and give you vital industry experience.
Our pharmacovigilance training courses meet
WHO-ISoP and FDA guidelines and are accredited by the ACCRE and other recognized accreditation boards.
You’ll learn the basics of pharmacovigilance, why it’s necessary, its history, and how to find career opportunities within the industry.
You’ll look at different methodologies, pharmacovigilance regulation, pharmacovigilance audit and risk management, and vaccine pharmacovigilance.
You’ll also discover where to find further information to enhance your pharmacovigilance knowledge and study individual case reports to get to grips with the finer details of the subject.
At the end of the course, you will receive your certification. Then you’re ready to set out on your pharmacovigilance career.
After achieving your certification, you’ll open up a world of opportunities in pharmacovigilance and be qualified for entry-level roles including, but not limited to the following Drug Safety Jobs:
Pharmacovigilance Jobs
Pharmacovigilance Jobs Entry Level
18,000 Pharmacovigilance Jobs (always include a SPECIFIC cover letter for all jobs and follow up at least twice by email if you do not hear back to show interest to every single job).
Drug safety or Pharmacovigilance scientist (specialist or associate)
Drug safety or PV manager
Safety or PV reviewer
Pharmacovigilance Quality Compliance
Clinical Quality specialist
Medical Safety scientist/specialist/reviewer
Local safety officer
Clinical trial project safety associate (reviewer or specialist)
MedDRA coder
Pharmacovigilance safety and analytics reporting analyst/specialist/associate
Pharmacovigilance Auditor or PV Inspection readiness officer
• Safety or Pharmacovigilance Physician (medical director, MD/MBBS, IMG)
• Safety Compliance Writer
• Good PV Practices manager
• GCP specialist
• Pharmacovigilance vendor
• Case processing specialist
• Clinical trial case processing safety specialist
• Post-marketing case processing safety specialist
• Epidemiology safety associate (MPH) • Risk management manager
• Signal management specialist
• Periodic reporting specialist• Regulatory affairs safety specialist
You’ll also be qualified to act as an onsite safety representative for the duration of a given contract.
Pharmacovigilance Salary
The pandemic has demonstrated just how vital the pharmaceutical industry is to the smooth running of the country and the economy. And with the average entry-level salary in pharmacovigilance in the region of $69,000, it provides a unique opportunity to do your duty and be well-rewarded.
Once you are experienced in
pharmacovigilance, you can expect to command a salary of around $114,000.
And after 3-10 years in the industry, you can expect to earn $136,000. Based on salary, the US is the best country for pharmacovigilance jobs although pharmacovigilance is paid well globally as well.
We have trained over 1,800 clinical research and pharmacovigilance professionals and cover global clinical safety and pharmacovigilance as well as argus safety data base certification in our online, on-demand course. Our drug safety training is provided online and can be completed in less than a week. This is a great alternative to a diploma course in pharmacovigilance as you can finish quickly and still get an advanced level of understanding under your belt.
You can speak with our enrollment advisors for assistance in pricing and scholarship. Completed certification helps demonstrate your interest and knowledge to employers.
A career in pharmacovigilance is rewarding both personally and financially.
But like all new career paths, it can be difficult to gain experience or demonstrate your commitment from the outside. Achieving an accredited PV certification shows potential employers that you are serious about a career in the industry. It proves that you have the required knowledge and understanding of pharmacovigilance to add value to their organization.
For further details, call and speak to one of our 24/7 enrollment representatives through the orange chat box.
Good pharmacovigilance practice - ICH GCP guidelines for pharmacovigilance
Pharmacovigilance certification
Pharmacovigilance Certification
by CCRPS pharmacovigilance training institute is a globally-accepted, accredited Online Pharmacovigilance Training Course
Fundamentals Of Global Pharmacovigilance
Introduction to Drug Safety and PV FREE PREVIEW
Key PV Terminology (Side Effect, Drug Safety, and Risk Terms) FREE PREVIEW
International Regulatory Requirements and Guidelines Overview FREE PREVIEW
Pharmacovigilance Quiz
Regional Regulatory Requirements (FDA, EMA, Japan, China) FREE PREVIEW
Postmarketing Surveillance (PMS) and Safety Management FREE PREVIEW
GVP - Pharmacovigilance Abbreviations Advanced Review of Adverse Event Reporting
Advanced Review Of Pharmacovigilance
Advanced Practice of Pharmacovigilance Pharmacovigilance Quiz
Additional Encompassing and Confusing Terms in Pharmacovigilance
MedDRA (Hierarchy, Searching, Terms, Exporting, Assessing, Important Medical Events)
Pharmacovigilance Quiz
Need for Pharmacovigilance
The History of Pharmacovigilance FREE PREVIEW Roles in Pharmacovigilance Pharmacovigilance Quiz
Key Stakeholders in Pharmacovigilance Pharmacovigilance Quiz
Post-marketing AE Processing and Reporting(ICSR, Case Processing, Narrative Writing, & International Aggregate Reporting)
Pharmacovigilance Quiz
Signal Detection (Detection, Validation, Prioritization, and Action)
Pharmacovigilance Quiz
Risk Assessment, Plan, and Management Pharmacovigilance Quiz
Vaccine Surveillance - COVID-19 Updated (AEFI, Vaccinology, AESI, AVSS, Communication, and Case Studies)
Post-authorization/Post-marketing Regulations in Pharmacovigilance
Argus Safety Database Certification
Argus Safety Database Certification Part 1 (Into and Video Demos)
Argus Safety Database Certification Part 2 Argus Safety Database Certification Part 3 Argus Safety Database Certification Part 4 Argus Safety Database Certification Part 5 Argus Safety Database Certification Part 6 Oracle Argus Safety User Guide
Resources
International Pharmacovigilance Initiatives and Guidelines - EMA
DIA Safety and Pharmacovigilance Competencies
Pharmacovigilance Career Resources
WHO-ISoP Pharmacovigilance Resources
E2E-Pharmacovigilance Planning
GVP XVI Addendum: Educational Materials
GVP Module I-IV PV Systems, PSMF, Inspections & Audits
GVP I: Pharmacovigilance Systems
GVP VIII: Post-authorisation Safety Studies
GVP III: Pharmacovigilance Inspections
GVP IX Addendum: Methodological aspects
GVP V: Risk management systems
GVP IX: Signal management-
GVP VIII Addendum: Requirements- recommendations_en-1
GVP XV: Safety Communication
GVP XVI: Risk-minimization measures
GVP II: Pharmacovigilance System Master File
GVP VI: Duplicate Management
GVI VI: Pharmacovigilance Audits
GVP X: Additional Monitoring
GVP VII: Periodic Safety Update Report
GVP VI: Collection, management, and submission of reports
Pharmacovigilance Definition
Investigational product (IP): Any drug, device, therapy, or intervention after Phase I trial
Event: Any undesirable outcome (i.e. undesired laboratory finding, symptom, or disease)
Adverse event/experience (AE): Any related OR unrelated event occurring during use of IP
Adverse drug reaction/effect (ADR/ADE): AE that is related to product
Serious Adverse Event (SAE): AE that causes death, disability, incapacity, is life- threatening, requires/prolongs hospitalization, or leads to birth defect
Unexpected Adverse Event (UAE): AE that is not previously listed on product information
Unexpected Adverse Reaction: ADR that is not previously listed on product information
Suspected Unexpected Serious Adverse Reaction (SUSAR): Serious + Unexpected + ADR
Causality assessment: Review of drug (i.e. pharmacology, pathophysiology, time overlap of event and IP administration, dechallenge and rechallenge, confounding patient-specific disease manifestations or other medications, and other explanations) to determine if certain, probable/likely, possible, unlikely, conditional/unclassified, unassessable/unclassifiable.
Dechallenge vs. Rechallenge: Causality assessed by measuring AE outcomes when withdrawing vs. re-administering IP
Causal relationship: Determined to be certain, probable/likely, or possible (AE + Causal -> ADR)
Seriousness: based on outcome + guide to reporting obligations (i.e. death SAE -> report in 3 days) mnemonic: seriOOusness = OutcOme
• Severity: based on intensity (mild, moderate, severe) regardless of medical outcome (i.e. severe headache -> not serious) mnemonic: severiTTy = InTensiTy
• Temporal relationship: Positive if AE timing within use or half-life of drug (positive, suggestive, compatible, weak, negative)
• Signal: Event information after drug approved providing new adverse or beneficial knowledge about IP that justifies further studying (PMS = signal detection, validation, confirmation, analysis, & assessment and recommendation for action)
• Identified risk: Event noticed in signal evaluation known to be related/listed on product information
• Potential risk: Event noticed in signal evaluation scientifically related to product but not listed on product information
• Important risk/Safety concern: Identified or potential risk that can impact risk-benefit ratio
• Risk-benefit ratio: Ratio of IP’s positive therapeutic effect to risks of safety/efficacy
• Summary of product characteristics (SmPC/SPC): guide for doctors to use IP
Good Pharmacovigilance Practice - ICH GCP guidelines for pharmacovigilance
E2A: Clinical safety data management: Definitions and standards for expedited reporting
What is e2b in pharmacovigilance? E2B: Electronic reporting of adverse events: Implements electronic reporting R3 E-ICSR Implementation Guide I Link CIOMS I to E2B Guide
E2C: Periodic benefit- risk evaluation report (PBRER): Format and content of safety updates for reporting at intervals to regulatory authorities
E2D: Post-approval safety data management: Definitions and standards for expedited reporting: Guidance for gathering and reporting information
E2E: Pharmacovigilance planning: Helps to make PMS plan, especially in early Phase IV
E2F: Development Safety Update Report (DSUR): Standard for periodic reporting on drugs
M1: Medical dictionary for Regulatory activities (MedDRA)
M4: The Common Technical Document (CTD): Formatting of reports to regulatory bodies (M4 Organization, M4Quality, M4Safety, M4Efficacy)
CIOMS I: The international reporting form (links with ICH E2B)
CIOMS II: Periodic safety update reports manual
CIOMS III: Core data sheets
CIOMS IV: Benefit-risk assessments
CIOMS VI: Clinical trial safety data
CIOMS VII: Development safety update reports
CIOMS VIII: Practical Aspects of Signal Detection in Pharmacovigilance
Global Pharmacovigilance laws and regulations - IAOCR Directory
Local Pharmacovigilance Regulatory Bodies
Australia – Therapeutic Goods Administration (TGA)
New Zealand – MEDSAFE
North America
Canada – Health Canada ~2%
USA* – FDA: Food and Drug Administration ~33%
Central/South America
Argentina – ANMAT
Brazil – Agencia Nacional de Vigilancia Sanitaria (ANVISA)
Chile – Instituto de Salud Publico (ISP)
Columbia – Instituto Nacional de Vigilancia Medicamentos y Alimentos (INVIMA)
Costa Rica – Ministerio de Salud
Cuba – CECMED
Dominican Republic – Dirección General de Drogas y Farmacias
Jamaica – Ministry of Health
Mexico – Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
Paraguay – Ministro de Salud Pública y Bienestar Social
Peru – Ministerio de Salud
Uruguay – Ministerio de Salud Publica
European Union* – EMA: European Medicines Agency ~17%
Armenia – Scientific Centre of Drug and Medical Technology Expertise
Austria – Agency for Health and Food Safety (AGES)
Belgium – Federal Agency for Medicines and Health Products
Bulgaria – Bulgarian Drug Agency
Croatia – Agency for Medicinal Products and Medical Devices of Croatia
Cyprus – Ministry of Health
Czech Republic – State Institute for Drug Control
Denmark – Danish Medicines Agency
Estonia – State Agency of Medicines
Finland – Finish Medicines Agency
France – Agence Nationale de Sécurité du Medicament et des Produits de Santé
Germany – Federal Institute for Drugs and Medical Devices
Georgia – Regulation Agency for Medical and Pharmaceutical Activities
Greece – National Organisation for Medicines
Hungary – National Institute of Pharmacy
Iceland – Icelandic Medicines Agency
Ireland – Irish Medicines Board
Italy – National Institute of Health
Lithuania – State Medicines Control Agency
Luxembourg – Ministry of Health
Malta – Maltese Medicines Authority
Moldova – Medicines Agency
Netherlands – Medicines Evaluation Board
Norway – Norwegian Medicines Agency
Poland – The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal – National Authority of Medicines and Health Products
Romania – National Medicines Agency
Russia – Ministry of Health of the Russian Federation• Serbia – Medicines and Medical Devices Agency of Serbia
• Slovakia – State Institute for Drug Control • Slovenia – Ministry of Health
• Spain – Spanish Medicines Agency
• Sweden – Medical Products Agency• Switzerland – Swiss Agency for Therapeutic Products
• Ukraine – Ministry of Health
• United Kingdom – Medicines and Healthcare Regulatory Agency (MHRA)
• Bahrain – I-SEHA
• Egypt – Ministry of Health
• Iran – Ministry of Health
• Israel – Ministry of Health
• Jordan – Jordan Food and Drug Administration
• Lebanon – Ministry of Public Health
• Saudi Arabia – Saudi Food and Drug Authority
• United Arab Emirates – Ministry of Health
• Bangladesh – Directorate General of Drug Administration (DGDA)
• Bhutan – Drug Regulatory Authority
• China* – CFDA/NMPA: State Food and Drug Administration
• India – Central Drug Standards Control Organization (CDSCO)
• Indonesia – POM (Pengawas Obat dan Makanan)
• JAPAN* – PMDA: Ministry of Health, Labour and Welfare ~12%
• Korea (South) – Korean Food and Drug Administration (KFDA) ~1%
• Laos – Food and Drug Department
• Malaysia – Ministry of Health (MOH)
• Nepal – Department of Drug Administration
• Philippines – Department of Health (DOH)
• Singapore – Health Sciences Authority (HSA)
• Sri Lanka – Ministry of Health (MOH)
• Taiwan (Republic of China) – Taiwan Food and Drug Administration (TFDA)
• Thailand – Food and Drug Administration of Thailand
• Vietnam – Drug Administration of Vietnam
• Algeria – Ministry of Health and Population • Botswana – Ministry of Health (MOH)
• Burkina Faso – Le Ministère de la Santé• Ghana – Food and Drugs Authority
• Kenya – Pharmacy and Poisons Board
• Morocco – Ministry of Health
• Nigeria – National Agency for Food and Drug Administration and Control
• Rwanda – Ministry of Health
• Senegal – Ministère de la Santé et de l’Action Sociale
• South Africa – Medicines Control Council (MCC)
• Swaziland – Ministry of Health
• Tanzania – Tanzania Food and Drug Authority (TFDA)
• Uganda – National Drug Authority