p.7
Adverse Drug Reactions (ADR) and Adverse Events (AE)
Is a causal relationship necessary for an occurrence to be classified as an Adverse Event (AE)?
No, it does not necessarily have to have a causal relationship with the treatment.
p.6
Pharmacovigilance Definition and Objectives
How does Pharmacovigilance promote safe use of medicinal products?
By providing timely information about safety to patients, healthcare professionals, and the public.
p.17
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does causality mean in pharmacovigilance?
The relationship between the suspect product and the adverse drug event.
p.10
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is the definition of an adverse event?
Any unfavorable or unintended sign, symptom, or disease associated with the use of a medicinal product.
p.2
Types of Reports: PSUR, PBRER, and DSUR
What is the DSUR?
Development Safety Update Report.
p.7
Adverse Drug Reactions (ADR) and Adverse Events (AE)
Can an Adverse Event (AE) include abnormal laboratory findings?
Yes, it can include any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.
p.2
Good Pharmacovigilance Practices (GVP)
What does DHPC stand for?
Direct Healthcare Professional Communication.
p.8
Adverse Drug Reactions (ADR) and Adverse Events (AE)
In what scenarios can adverse reactions arise?
From use within or outside the marketing authorisation or from occupational exposure.
p.14
Reporting and Case Submission Timelines
What does Day Zero refer to?
The first date on which any representative of an organization was notified of the minimum essential elements for expedited reporting.
p.15
Regulatory Authorities and Guidelines
What is the regulatory body for drug safety in the USA?
United States Food and Drug Administration (USFDA).
p.14
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does SUSAR stand for?
Suspected Unexpected Serious Adverse Reaction.
p.23
Risk Management Plans (RMP) and Risk Minimization Measures
What does compassionate use of a medicinal product mean?
Making a medicinal product available for compassionate reasons to patients with seriously debilitating or life-threatening diseases who cannot be treated satisfactorily with authorized products.
p.18
Regulatory Authorities and Guidelines
What is the WHO Drug Dictionary (WHO DD)?
An international classification of drugs providing proprietary and non-proprietary names of medicinal products used in different countries, together with all active ingredients.
p.11
Good Pharmacovigilance Practices (GVP)
What is a registry in pharmacovigilance?
An organised system that collects uniform data on specified outcomes in a defined population based on disease, condition, or exposure.
p.29
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does 'Lack of Efficacy (LOE)' refer to?
The absence of expected or desired effect related to a therapy.
p.23
Risk Management Plans (RMP) and Risk Minimization Measures
What is a requirement for a medicinal product to be considered for compassionate use?
It must be subject to an application for central marketing authorization or undergoing clinical trials.
p.23
Risk Management Plans (RMP) and Risk Minimization Measures
What type of diseases are eligible for compassionate use of medicinal products?
Chronically or seriously debilitating diseases and life-threatening diseases.
p.7
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What are the minimum criteria required for a valid case?
An identifiable reporter, an identifiable patient, a suspect product, and an adverse drug event.
p.7
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What defines an Adverse Event (AE)?
Any untoward medical occurrence in a patient following the administration of a pharmaceutical product, which may not necessarily have a causal relationship with the treatment.
p.10
Clinical Trials and Serious Adverse Events (SAE)
What is a clinical trial?
An investigation in human subjects to discover or verify clinical and pharmacological effects, identify adverse reactions, and study pharmacokinetics of investigational medicinal products.
p.17
Adverse Drug Reactions (ADR) and Adverse Events (AE)
When is a case considered to be medically confirmed?
If it contains at least one event confirmed or reported by a Health Care Professional (HCP).
p.14
Risk Management Plans (RMP) and Risk Minimization Measures
What are Patient Support Programs (PSPs)?
Programs designed to assist patients in managing their treatment and therapy.
p.15
Reporting and Case Submission Timelines
What is the reporting timeline for a SUSAR that is not life-threatening and does not result in death?
It must be submitted within fifteen (15) calendar days.
p.18
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What should a narrative in a report consist of?
Precise and concise information about the source of the report, patient demographics, medical history, concomitant medications, suspect product details, and adverse event details in an orderly manner.
p.15
Regulatory Authorities and Guidelines
What is the name of the regulatory body in Japan for health and welfare?
Ministry of Health, Labour and Welfare (MHLW).
p.19
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What indicates a positive dechallenge?
When the adverse event subsides or disappears after the removal of the drug.
p.24
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does diagnosis, prevention, monitoring, and treatment of disease involve?
It involves the process of identifying illnesses, preventing their occurrence, monitoring progress, and providing treatment or alleviation.
p.4
Regulatory Authorities and Guidelines
What is the full form of INN?
International non-proprietary name.
p.15
Regulatory Authorities and Guidelines
What is the regulatory authority responsible for drug control in India?
Central Drugs Standard Control Organization (CDSCO).
p.11
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does 'medically significant' mean in the context of adverse events?
Events that do not meet specific criteria but are serious enough that treatment is needed to prevent more severe outcomes.
p.28
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is a medication error?
When a doctor unintentionally prescribes/administers a drug by an unauthorized route of administration.
p.1
Regulatory Authorities and Guidelines
What is the meaning of ATMP?
Advanced therapy medicinal product.
p.5
Good Pharmacovigilance Practices (GVP)
What is the role of a 'QPPV'?
Qualified Person responsible for Pharmacovigilance.
p.45
Signal Detection and Management
What does a Refuted signal indicate?
A validated signal that has been determined to be 'false' after further assessment.
p.28
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What constitutes an overdose?
Administration of a quantity of a medicinal product above the maximum recommended dose according to the authorized product information.
p.10
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What constitutes a serious adverse event?
Results in death, is life-threatening, or requires inpatient hospitalization.
p.17
Good Pharmacovigilance Practices (GVP)
What replaces Volume 9A in pharmacovigilance legislation?
Good pharmacovigilance practice (GVP) guidelines.
p.9
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is an Adverse Drug Reaction (ADR)?
An adverse event that has a causal association with a drug.
p.18
Pharmacovigilance Definition and Objectives
Who manages the UMC?
Uppsala Monitoring Centre.
p.8
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What are conditions of use outside the marketing authorisation?
Off-label use, overdose, misuse, abuse, and medication errors.
p.20
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What are the categories for estimating the frequency of Adverse Drug Reactions (ADRs)?
Very common (>10%), Common (>1% and <10%), Uncommon (>0.1% and <1%), Rare (>0.01% and <0.1%), Very rare (<0.01%).
p.17
Good Pharmacovigilance Practices (GVP)
What are the GVP guidelines?
Guidelines released by the European Medicines Agency for good pharmacovigilance practices.
p.11
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What outcomes indicate a significant adverse event?
Persistent or significant disability/incapacity, congenital anomaly (birth defect), or medically significant events requiring treatment.
p.2
Regulatory Authorities and Guidelines
What does eCTD stand for?
Electronic Common Technical Document.
p.1
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does AEFI refer to?
Adverse event following immunization.
p.16
Good Pharmacovigilance Practices (GVP)
What does Volume 9A provide guidance on?
Requirements, procedures, roles, and activities in pharmacovigilance.
p.1
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is AESI?
Adverse event of special interest.
p.1
Risk Management Plans (RMP) and Risk Minimization Measures
What does aRMM stand for?
Additional risk minimization measure.
p.30
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is the primary function of Aggregate Reporting?
To compile safety data for a drug over a prolonged period.
p.21
Risk Management Plans (RMP) and Risk Minimization Measures
What is covered in CIOMS IV?
Benefit-risk assessments.
p.23
Regulatory Authorities and Guidelines
What are the modules mentioned in the context of safety communications?
Module XV – Safety communications, Module XVI – Risk minimisation measures, Module XVI Addendum I – Educational materials, Module XVI Addendum II – Methods for effectiveness evaluation.
p.30
Adverse Drug Reactions (ADR) and Adverse Events (AE)
How does Aggregate Reporting differ from single-case reporting?
Aggregate Reporting compiles data over time, while single-case reporting involves individual AE reports.
p.33
Types of Reports: PSUR, PBRER, and DSUR
What is a Development Safety Update Report (DSUR)?
A comprehensive annual review and evaluation of safety information collected during the reporting period related to a drug under investigation.
p.32
Types of Reports: PSUR, PBRER, and DSUR
What is the cut-off date for data in a Periodic Benefit-Risk Evaluation Report (PBRER)?
The date designated based on the international birth date.
p.31
Regulatory Authorities and Guidelines
What is the DIBD?
The date of approval of the first authorization for conducting an interventional clinical trial in any country.
p.16
Good Pharmacovigilance Practices (GVP)
Who do GVP apply to?
Marketing-authorisation holders, EMA, and regulatory authorities in EU Member States.
p.1
Good Pharmacovigilance Practices (GVP)
What is CCSI?
Company core safety information.
p.14
Risk Management Plans (RMP) and Risk Minimization Measures
What are post-approval named patient programs?
Programs that allow individual patients access to unapproved therapies.
p.15
Reporting and Case Submission Timelines
What is the reporting timeline for a SUSAR that is life-threatening or results in death?
It must be reported within seven (7) calendar days.
p.17
Adverse Drug Reactions (ADR) and Adverse Events (AE)
Who qualifies as a Health Care Professional (HCP)?
Physicians, nurses, pharmacists, etc.
p.10
Clinical Trials and Serious Adverse Events (SAE)
Can clinical trials be conducted in multiple sites?
Yes, clinical trials can be carried out in one or multiple sites and in one or more Member States.
p.18
Pharmacovigilance Definition and Objectives
Who uses the UMC for identifying drug names?
Pharmaceutical companies, clinical trial organizations, and drug regulatory authorities.
p.9
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does 'Unexpected Adverse Reaction' mean?
An adverse reaction inconsistent with the applicable product information.
p.20
Pharmacovigilance Definition and Objectives
What is VigiBase?
The largest repository of drug safety data across the globe, maintained by Uppsala Monitoring Centre (UMC).
p.8
Adverse Drug Reactions (ADR) and Adverse Events (AE)
Can the term 'side effect' apply to beneficial consequences?
Yes, it can also refer to beneficial but unintended consequences of drug use.
p.23
Risk Management Plans (RMP) and Risk Minimization Measures
Who can benefit from compassionate use of a medicinal product?
Patients with chronically or seriously debilitating diseases or those whose conditions are life-threatening.
p.20
Regulatory Authorities and Guidelines
What does CIOMS stand for?
Council for International Organizations of Medical Sciences.
p.19
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does a negative dechallenge suggest?
That the event persists even after removal of the drug, indicating a causal relationship is unlikely.
p.34
Types of Reports: PSUR, PBRER, and DSUR
What are the different sections included in a PBRER?
Title page, Executive Summary, Table of Contents, Introduction, Worldwide Marketing Approval Status.
p.24
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is the format and content required for an ICSR?
It must include details of suspected adverse reactions related to a medicinal product for a specific patient.
p.3
Regulatory Authorities and Guidelines
What does EVCTM represent?
EudraVigilance Clinical Trial Module.
p.4
Regulatory Authorities and Guidelines
What is MAH an abbreviation for?
Marketing authorisation holder.
p.43
Signal Detection and Management
How can a safety signal be closed?
It can be closed because it is refuted or determined to be a potential or identified risk.
p.2
Regulatory Authorities and Guidelines
What does EPAR stand for?
European Public Assessment Report.
p.48
Signal Detection and Management
What does signal validation help justify?
Further analysis of the detected signal.
p.27
Adverse Drug Reactions (ADR) and Adverse Events (AE)
At what stages can medication errors occur?
Prescribing, storage, dispensing, preparation, and administration.
p.5
Clinical Trials and Serious Adverse Events (SAE)
What does 'RCT' represent?
Randomised clinical trial.
p.45
Signal Detection and Management
How does ICH describe refuted signals?
As signals that have been refuted as 'false' based on medical judgment and scientific evaluation.
p.32
Types of Reports: PSUR, PBRER, and DSUR
What is the cut-off date for data in a Development Safety Update Report (DSUR)?
The date designated based on the development international birth date.
p.6
Pharmacovigilance Definition and Objectives
What does Pharmacovigilance aim to prevent?
Harm from adverse reactions in humans arising from authorized medicinal products.
p.8
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is an Adverse Drug Reaction (ADR)?
A noxious and unintended response to a medicinal product with a reasonable possibility of a causal relationship.
p.10
Clinical Trials and Serious Adverse Events (SAE)
What are the objectives of a clinical trial?
To ascertain the safety and/or efficacy of one or more investigational medicinal products.
p.6
Pharmacovigilance Definition and Objectives
What is the role of Pharmacovigilance in public health?
It contributes to the protection of patient and public health.
p.9
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is the key difference between AE and ADR?
AE may not have a causal relationship with a drug, while ADR always does.
p.2
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does DME stand for?
Designated Medical Event.
p.8
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is a side effect in medicine?
An effect, whether therapeutic or adverse, that is secondary to the one intended.
p.34
Types of Reports: PSUR, PBRER, and DSUR
What does a PSUR/PBRER provide?
An analysis of the risk-benefit profile of a medicinal product based on safety, efficacy, and effectiveness information.
p.14
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is defined as a SUSAR?
An untoward and unintended response to a study drug that meets serious criteria.
p.21
Regulatory Authorities and Guidelines
What does CIOMS I represent?
The international reporting form.
p.8
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What factors can cause variation in side effects among individuals?
Disease state, age, weight, gender, ethnicity, and general health.
p.15
Regulatory Authorities and Guidelines
Which organization regulates therapeutic goods in Australia?
Therapeutic Goods Administration (TGA).
p.11
Good Pharmacovigilance Practices (GVP)
What is the quality system in a pharmacovigilance system?
The organisational structure, responsibilities, procedures, processes, resources, and resource management within the pharmacovigilance framework.
p.26
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is off-label use of a medicinal product?
Using a medicinal product for a medical purpose not in accordance with the terms of the marketing authorization.
p.16
Good Pharmacovigilance Practices (GVP)
Who is Volume 9A intended for?
Marketing Authorisation Holders (MAH) and Competent Authorities.
p.19
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is a positive rechallenge?
When the adverse event reappears after the drug is reintroduced, strongly suggesting a causal relationship.
p.25
Clinical Trials and Serious Adverse Events (SAE)
What is a Non-interventional trial?
A study where medicinal products are prescribed in the usual manner according to marketing authorization.
p.29
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What characterizes product counterfeits?
They may contain lower quality substances, wrong doses, or be mislabelled to hide the source.
p.48
Signal Detection and Management
What should signal validation take into account?
Strength of the evidence, clinical relevance, and previous awareness of the association.
p.40
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is a PADER?
A Periodic Adverse Drug Experience Report submitted to the USFDA as part of post-cumulative safety reports.
p.3
Regulatory Authorities and Guidelines
What is the function of EVDAS?
EudraVigilance Data Analysis System.
p.19
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does rechallenge refer to?
The administration of a drug again to a patient after its previous withdrawal.
p.39
Drug Interactions and Medication Errors
What patterns are being observed in medication errors?
Patterns of medication errors and potential medication errors.
p.6
Pharmacovigilance Definition and Objectives
What is Pharmacovigilance?
The science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any medicine-related problem.
p.9
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is an Adverse Event (AE)?
An occurrence that may not be causally related to a drug.
p.2
Regulatory Authorities and Guidelines
What is the meaning of DIBD?
Development International Birth Date.
p.6
Pharmacovigilance Definition and Objectives
What does Pharmacovigilance cover?
The entire life-cycle of a medicinal product.
p.15
Regulatory Authorities and Guidelines
Which agency oversees medicines in the UK?
Medicines and Healthcare Regulatory Agency (MHRA).
p.9
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is an Advanced Therapy Medicinal Product (ATMP)?
A medicinal product for human use related to gene therapy, somatic cell therapy, or tissue engineering.
p.34
Types of Reports: PSUR, PBRER, and DSUR
What is the main difference between a PSUR and a PBRER?
A PSUR serves as an interval safety report, whereas a PBRER is a cumulative benefit-risk report.
p.14
Adverse Drug Reactions (ADR) and Adverse Events (AE)
Which serious criteria can classify a reaction as SUSAR?
Results in death, is life-threatening, requires hospitalization, results in persistent disability, or is a congenital anomaly.
p.2
Good Pharmacovigilance Practices (GVP)
What is the eRMR?
Electronic Reaction Monitoring Report.
p.21
Types of Reports: PSUR, PBRER, and DSUR
What is the purpose of CIOMS II?
Periodic safety update reports manual.
p.27
Drug Interactions and Medication Errors
What does 'population' refer to in the context of medicine?
Different groups of patients receiving medication.
p.20
Pharmacovigilance Definition and Objectives
Who maintains VigiBase?
Uppsala Monitoring Centre (UMC).
p.48
Signal Detection and Management
What is the primary focus of signal validation in pharmacovigilance?
Evaluating data to verify the existence of a new potentially causal association or a new aspect of a known association.
p.26
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does it mean to misuse a medicinal product?
Intentionally and inappropriately using a medicinal product not in accordance with the authorized product information.
p.45
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is a major safety issue in clinical studies?
An unexpectedly increased rate of fatal or life-threatening adverse events.
p.19
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is the purpose of dechallenge?
To withdraw a drug and monitor its effect on an adverse event.
p.26
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is abuse of a medicinal product?
Persistent or sporadic, intentional excessive use of medicinal products causing harmful physical or psychological effects.
p.29
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What may counterfeit medicinal products have?
Counterfeit packaging, wrong ingredients, or a lower proportion of the active substance.
p.50
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is an adverse reaction suggested by well-documented spontaneous reports?
An adverse reaction with strong causality supported by temporal relationship and biological plausibility, such as anaphylactic reactions.
p.24
Clinical Trials and Serious Adverse Events (SAE)
What is the purpose of a medical device?
To be used for diagnostic and/or therapeutic purposes in human beings.
p.30
Risk Management Plans (RMP) and Risk Minimization Measures
Why are periodic reports important in drug safety?
They play a key role in the risk-benefit evaluation of the drug.
p.29
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is meant by disease progression in this context?
Atypical or accelerated progression of disease indicating poor efficacy of the product.
p.28
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is occupational exposure to a medicinal product?
Exposure to a medicinal product as a result of one’s professional or non-professional occupation for reporting suspected adverse reactions.
p.4
Good Pharmacovigilance Practices (GVP)
What is MedDRA?
Medical Dictionary for Regulatory Activities.
p.30
Good Pharmacovigilance Practices (GVP)
What types of activities are involved in periodic reporting?
Collective case analysis, monitoring regulatory actions, and literature searches.
p.33
Types of Reports: PSUR, PBRER, and DSUR
What does PSUR stand for?
Periodic Safety Update Report.
p.19
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does dechallenge mean in pharmacovigilance?
It refers to the withdrawal of a drug suspected of causing an adverse event.
p.20
Regulatory Authorities and Guidelines
What is CIOMS?
The Council for International Organizations of Medical Sciences, established jointly by WHO and UNESCO in 1949 as a non-profit organization.
p.9
Regulatory Authorities and Guidelines
Which regulation defines Advanced Therapy Medicinal Products (ATMP)?
Regulation (EC) No 1394/2007.
p.27
Drug Interactions and Medication Errors
What does posology refer to in medicine?
The study of different doses of medication.
p.34
Types of Reports: PSUR, PBRER, and DSUR
What additional data does a PBRER include that a PSUR does not?
Data on efficacy and effectiveness from ongoing or updated clinical trials and cohort studies.
p.24
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is an Individual Case Safety Report (ICSR)?
It is a report detailing one or several suspected adverse reactions to a medicinal product occurring in a single patient at a specific point in time.
p.28
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is off-label use?
When a doctor intentionally prescribes/administers a drug by an unauthorized route of administration.
p.27
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is a medication error?
An unintended failure in the drug treatment process that may harm the patient.
p.2
Regulatory Authorities and Guidelines
What is the EMA?
European Medicines Agency.
p.32
Types of Reports: PSUR, PBRER, and DSUR
What is the cut-off date for data in a Periodic Safety Update Report (PSUR)?
The date designated for data to be included in a PSUR.
p.27
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does a failure in the drug treatment process refer to?
Human or process-mediated failures, not lack of drug efficacy.
p.31
Regulatory Authorities and Guidelines
What does DIBD stand for?
Developmental International Birth Date.
p.16
Good Pharmacovigilance Practices (GVP)
What are Good Pharmacovigilance Practices (GVP)?
A set of measures to facilitate pharmacovigilance in the EU.
p.44
Signal Detection and Management
What is a Non-confirmed signal in the EU signal management process?
A validated signal in EPITT that does not require further analysis and prioritization by PRAC at that time.
p.26
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does medicine administration through different routes refer to?
Administering medicine by methods not approved for its use.
p.33
Types of Reports: PSUR, PBRER, and DSUR
What is the purpose of a DSUR?
To assure regulators that sponsors are adequately monitoring and evaluating the evolving safety profile of the investigational drug.
p.50
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What are identified risks in the summary of product characteristics (SmPC)?
Adverse reactions included in section 4.8 of the SmPC, unless they are class-related reactions not specifically described with this product.
p.19
Adverse Drug Reactions (ADR) and Adverse Events (AE)
When is a rechallenge considered after a positive dechallenge?
When the adverse event subsides or disappears after the drug is removed.
p.43
Signal Detection and Management
What is a Newly identified signal?
A signal first identified during the reporting interval, prompting further actions or evaluation.
p.12
Adverse Drug Reactions (ADR) and Adverse Events (AE)
Who can provide unsolicited reports?
Healthcare professionals, patients, or consumers.
p.16
Good Pharmacovigilance Practices (GVP)
Do GVP cover centrally authorized medicines?
Yes, they cover centrally and nationally authorized medicines.
p.41
Risk Management Plans (RMP) and Risk Minimization Measures
What is the purpose of a REMS?
To help ensure that the benefits of a medication outweigh its risks.
p.30
Regulatory Authorities and Guidelines
To whom are aggregate reports submitted?
Various regulatory agencies.
p.38
Regulatory Authorities and Guidelines
What does worldwide marketing authorization status indicate?
The approval of a medicinal product for sale in different regions.
p.50
Clinical Trials and Serious Adverse Events (SAE)
What can the comparator be in a clinical trial?
Placebo, an active substance, or non-exposure.
p.22
Good Pharmacovigilance Practices (GVP)
What is addressed in Module II of GVP?
Pharmacovigilance system master file.
p.33
Types of Reports: PSUR, PBRER, and DSUR
What is the purpose of a PSUR/PBRER?
To provide an evaluation of the risk-benefit balance of a medicinal product for submission during the post-authorisation phase.
p.43
Signal Detection and Management
What is a Closed signal in periodic benefit-risk evaluation reports?
A signal for which an evaluation was completed during the reporting interval.
p.16
Good Pharmacovigilance Practices (GVP)
What international framework does Volume 9A incorporate?
International agreements from the International Conference on Harmonisation (ICH).
p.24
Clinical Trials and Serious Adverse Events (SAE)
What is a medical device?
Any instrument, apparatus, appliance, software, or material intended for diagnostic and/or therapeutic purposes for human beings.
p.25
Clinical Trials and Serious Adverse Events (SAE)
How is patient assignment determined in a Non-interventional study?
It is not decided in advance by a trial protocol but falls within current practice.
p.13
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What types of sources provide unsolicited or spontaneous reports?
Patients, consumers, healthcare professionals, medical information enquiries, literature reports, internet/digital media, clinical trials, non-interventional studies, and registries.
p.21
Good Pharmacovigilance Practices (GVP)
What issues does CIOMS V address?
Practical issues in Pharmacovigilance.
p.43
Signal Detection and Management
What is an Ongoing signal in periodic benefit-risk evaluation reports?
A signal that remains under evaluation at the data lock point.
p.13
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What are solicited reports?
Reports derived from organized data systems, including clinical trials, non-interventional studies, and registries.
p.21
Clinical Trials and Serious Adverse Events (SAE)
What data does CIOMS VI deal with?
Clinical trial safety data.
p.25
Clinical Trials and Serious Adverse Events (SAE)
Are additional diagnostic or monitoring procedures applied to patients in a Non-interventional study?
No, no additional procedures shall be applied.
p.38
Good Pharmacovigilance Practices (GVP)
What does the history of pharmacovigilance system inspections analyze?
The impact of findings on the benefit-risk balance of medicinal products.
p.3
Regulatory Authorities and Guidelines
What is EVMPD?
EudraVigilance Medicinal Product Dictionary.
p.49
Risk Management Plans (RMP) and Risk Minimization Measures
What is the definition of an identified risk according to GVP Annex I (Rev 3)?
An untoward occurrence for which there is adequate evidence of an association with the medicinal product of interest.
p.39
Risk Management Plans (RMP) and Risk Minimization Measures
What does benefit-risk balance refer to?
The evaluation of the advantages and disadvantages of a medicinal product.
p.54
Risk Management Plans (RMP) and Risk Minimization Measures
What factors determine whether a risk is considered important?
The seriousness of the risk and its impact on public health.
p.21
Signal Detection and Management
What is the focus of CIOMS VIII?
Practical aspects of signal detection in Pharmacovigilance.
p.4
Regulatory Authorities and Guidelines
What is the role of NCA?
National competent authority.
p.38
Risk Management Plans (RMP) and Risk Minimization Measures
What actions might be taken for safety reasons during the marketing authorization period?
Actions can include product recalls, usage restrictions, or safety warnings.
p.48
Signal Detection and Management
What is the role of documentation in signal validation?
It must contain sufficient evidence demonstrating the existence of a new association or aspect.
p.41
Risk Management Plans (RMP) and Risk Minimization Measures
What type of medications typically require a REMS?
Medications with serious safety concerns.
p.39
Good Pharmacovigilance Practices (GVP)
What is the purpose of DHPC?
To inform healthcare professionals of the need to take specific actions or adapt their practices related to a medicinal product.
p.40
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What information should be included in a PADER?
Details of adverse drug experiences and relevant data as required.
p.50
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does causality in adverse reactions imply?
Strong support from temporal relationship and biological plausibility.
p.57
Risk Management Plans (RMP) and Risk Minimization Measures
What is the purpose of a Risk Management System (RMS)?
To identify, characterize, prevent, or minimize risks related to medicinal products.
p.5
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is a 'SAR'?
Serious Adverse Reaction.
p.53
Risk Management Plans (RMP) and Risk Minimization Measures
What are risk minimisation activities?
Product information advising on specific clinical actions to minimize risk or additional risk minimisation activities.
p.25
Clinical Trials and Serious Adverse Events (SAE)
What distinguishes the prescription of medicine in a Non-interventional study from the study itself?
The prescription is clearly separated from the decision to include the patient in the study.
p.2
Good Pharmacovigilance Practices (GVP)
What is EPITT?
European Pharmacovigilance Issues Tracking Tool.
p.48
Signal Detection and Management
Why is urgent attention and management sometimes required in pharmacovigilance?
To address potential patients’ or public health impacts that significantly affect the risk-benefit balance of a medicinal product.
p.24
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is involved in the monitoring and treatment of injury?
It includes diagnosis, monitoring, treatment, and alleviation or compensation for a handicap.
p.52
Signal Detection and Management
What is a signal in pharmacovigilance?
A signal arises from a spontaneous adverse reaction reporting system, indicating an event associated with other active substances within the same class.
p.29
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What could atypical disease progression include?
Faster progression than expected or unexpected elements attributed to treatment by the suspected product.
p.22
Good Pharmacovigilance Practices (GVP)
What does Module I of GVP cover?
Pharmacovigilance systems and their quality systems.
p.12
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What do unsolicited reports describe?
One or more suspected adverse reactions in patients given medicinal products.
p.2
Clinical Trials and Serious Adverse Events (SAE)
What is EudraCT?
European Clinical Trials Database.
p.41
Regulatory Authorities and Guidelines
Who can require a REMS for certain medications?
The U.S. Food and Drug Administration (FDA).
p.40
Risk Management Plans (RMP) and Risk Minimization Measures
What actions should be taken during the reporting interval period for ADRs?
Actions taken should be documented, or if unknown, the earliest known marketing authorization date for the product.
p.21
Pharmacovigilance Definition and Objectives
What is CIOMS's mission?
To advance public health through guidance on health research and policy, including ethics, medical product development, and safety.
p.46
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What identifies major safety issues in pharmacovigilance?
Through spontaneous reporting systems or scientific literature.
p.12
Reporting and Case Submission Timelines
What influences the timelines for case submissions?
Drug type, seriousness, and causality.
p.38
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What are significant changes made to the Reference Information (RI)?
Modifications regarding safety and efficacy related data since the last marketing authorization or renewal.
p.41
Reporting and Case Submission Timelines
How can follow-up information to adverse drug experiences be submitted?
In the next periodic report.
p.38
Clinical Trials and Serious Adverse Events (SAE)
What is meant by estimated exposure and usage patterns?
The expected number of patients using the product and how they use it.
p.41
Reporting and Case Submission Timelines
What is the frequency of periodic reporting for drug safety?
Except for 15-day alert reports.
p.30
Good Pharmacovigilance Practices (GVP)
What does Aggregate Reporting involve?
Reviewing cumulative safety information from a wide range of sources.
p.58
Drug Interactions and Medication Errors
What factors might a doctor consider regarding drug treatment progression?
The treatment with a company product or the lack of effectiveness.
p.57
Risk Management Plans (RMP) and Risk Minimization Measures
What are risk minimization measures?
Interventions intended to prevent or reduce the occurrence of adverse reactions associated with a medicine.
p.13
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What are registries used for in the context of drug safety?
Registries help gather and report information on adverse drug reactions.
p.51
Types of Reports: PSUR, PBRER, and DSUR
In which reports are potential risks classified?
In the PSUR (Periodic Safety Update Report) and PBRER (Periodic Benefit-Risk Evaluation Report).
p.53
Risk Management Plans (RMP) and Risk Minimization Measures
What are included as important potential risks in the RMP?
Those risks that could impact the risk-benefit balance of the medicinal product when further characterized and confirmed.
p.35
Clinical Trials and Serious Adverse Events (SAE)
What is the purpose of Cumulative and Interval Patient Exposure from Marketing Experience?
To analyze patient exposure to a product over time after it has been marketed.
p.12
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What are unsolicited or spontaneous reports?
Reports received from healthcare professionals, patients, or consumers describing suspected adverse reactions not derived from a structured study.
p.3
Regulatory Authorities and Guidelines
What does EV EWG stand for?
EudraVigilance Expert Working Group.
p.41
Risk Management Plans (RMP) and Risk Minimization Measures
What does REMS stand for?
Risk Evaluation and Mitigation Strategy.
p.26
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What are examples of off-label use?
Intentional use of a product in situations other than those described in the authorized product information.
p.31
Regulatory Authorities and Guidelines
When is the first data lock point for the DSUR?
The first anniversary of the DIBD.
p.45
Risk Management Plans (RMP) and Risk Minimization Measures
What is an Emerging safety issue?
A safety issue that requires urgent attention due to its potential major impact on risk-benefit balance.
p.44
Signal Detection and Management
What is a Non-validated signal?
A signal that lacks sufficient evidence for a new potentially causal association or a new aspect of a known association, warranting no further analysis.
p.43
Signal Detection and Management
What defines a Confirmed signal in the EU signal management process?
A validated signal entered in the European Pharmacovigilance Issues Tracking Tool (EPITT) that requires further analysis by the PRAC.
p.52
Pharmacovigilance Definition and Objectives
According to ICH-E2F Guideline, what is further evaluated in the pharmacovigilance plan?
Frequency, severity, seriousness, and outcome of the risk under normal conditions of use, and which populations are particularly at risk.
p.3
Regulatory Authorities and Guidelines
What module does EVPM refer to?
EudraVigilance Post-Authorisation Module.
p.49
Risk Management Plans (RMP) and Risk Minimization Measures
What does GVP module V (Rev 2) say about identified risks?
Undesirable clinical outcomes for which there is sufficient scientific evidence that they are caused by the medicinal product.
p.39
Good Pharmacovigilance Practices (GVP)
What is DHPC?
A communication intervention by which important information is delivered to healthcare professionals regarding medicinal products.
p.31
Regulatory Authorities and Guidelines
What is the IBD?
The date of the first marketing authorization for any product containing the active substance granted in any country.
p.3
Regulatory Authorities and Guidelines
What is EVWEB?
EudraVigilance Web Application.
p.51
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What raises suspicion of a causal relationship in clinical trials?
Adverse events with a significant difference compared to the comparator group.
p.30
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does an Aggregate Report summarize?
All existing safety experience with a medicinal product.
p.13
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What types of information can be derived from internet/digital media for reports?
Reports can be derived from websites, forums, chat rooms, blogs, and social networks.
p.58
Drug Interactions and Medication Errors
What can a person become obsessed with?
Any legal or illegal drugs.
p.49
Risk Management Plans (RMP) and Risk Minimization Measures
Where are identified risks typically documented?
In the Summary of Product Characteristics (SmPC).
p.52
Risk Management Plans (RMP) and Risk Minimization Measures
What typically warrants inclusion in the RMP?
An important identified risk that is likely to impact the risk-benefit balance of the product.
p.57
Risk Management Plans (RMP) and Risk Minimization Measures
What does the RMS cover?
The entire life-cycle of a medicinal product.
p.3
Good Pharmacovigilance Practices (GVP)
What does GVP stand for?
Good Pharmacovigilance Practices.
p.46
Signal Detection and Management
What is the role of the Pharmacovigilance Risk Assessment Committee (PRAC)?
To evaluate all available data relevant to a signal to determine regulatory actions.
p.38
Risk Management Plans (RMP) and Risk Minimization Measures
What is the purpose of summarizing significant safety and efficacy findings?
To assess the product's effectiveness and risks during the renewal period.
p.42
Signal Detection and Management
What is the purpose of Section 16.2 of the periodic benefit-risk evaluation report?
It relates to signals concerning adverse effects.
p.44
Signal Detection and Management
What is a Validated signal?
A signal that has been verified to have sufficient evidence for a new potentially causal association or a new aspect of a known association, justifying further analysis.
p.27
Drug Interactions and Medication Errors
What differentiates off-label use from medication error?
The element of 'intention' at the prescriber level.
p.5
Risk Management Plans (RMP) and Risk Minimization Measures
What does 'RMM' stand for?
Risk minimisation measure.
p.28
Adverse Drug Reactions (ADR) and Adverse Events (AE)
Does occupational exposure include manufacturing process exposure?
No, it does not include exposure to ingredients during the manufacturing process before the product is released.
p.1
Regulatory Authorities and Guidelines
What does CHMP stand for?
Committee for Medicinal Products for Human Use.
p.31
Regulatory Authorities and Guidelines
What does IBD stand for?
International Birth Date.
p.45
Risk Management Plans (RMP) and Risk Minimization Measures
Why might an Emerging safety issue require prompt regulatory action?
Due to its potential impact on patient or public health.
p.51
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What are non-clinical toxicological findings?
Findings that have not been observed or resolved in clinical studies.
p.25
Regulatory Authorities and Guidelines
What is the primary intended action of medical devices as per Dir 93/42/EEC Art 1(2)(a)?
Investigation, replacement or modification of anatomy or physiological processes, and control of conception.
p.54
Risk Management Plans (RMP) and Risk Minimization Measures
What should be included in the contraindications or warnings section of product information?
Any risk that is likely to be serious.
p.50
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What types of reactions are considered class-related reactions?
Reactions mentioned in the SmPC but not specifically described as occurring with the product.
p.1
Regulatory Authorities and Guidelines
What does CMDh refer to?
Coordination Group for Mutual Recognition and Decentralised Procedures – Human.
p.54
Good Pharmacovigilance Practices (GVP)
What is missing information in the context of pharmacovigilance?
Critical gaps in knowledge about a medicinal product related to safety or use in particular patient populations.
p.21
Regulatory Authorities and Guidelines
With which organizations is CIOMS officially related?
WHO and is an associate partner of UNESCO.
p.46
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What might lead to a contraindication or withdrawal of a medicinal product?
Major safety issues identified through reporting systems.
p.4
Clinical Trials and Serious Adverse Events (SAE)
What is PASS an abbreviation for?
Post-authorisation safety study.
p.33
Types of Reports: PSUR, PBRER, and DSUR
What does a PSUR/PBRER evaluate regarding risk minimisation?
The effectiveness of the risk minimisation measures described in the Risk Management Plan (RMP).
p.37
Risk Management Plans (RMP) and Risk Minimization Measures
Why is the ACO important?
It is essential for reevaluating the current benefit-risk balance to assure patients' health and safety.
p.5
Signal Detection and Management
What does 'SDR' indicate?
Signal of disproportionate reporting.
p.53
Risk Management Plans (RMP) and Risk Minimization Measures
Where are important risks identified and monitored?
In the DSUR, RMP, and PSUR/PBRER.
p.51
Signal Detection and Management
How are potential risks identified?
Through signal evaluation.
p.22
Good Pharmacovigilance Practices (GVP)
What is covered in Module VI?
Collection, management and submission of reports of suspected adverse reactions.
p.58
Drug Interactions and Medication Errors
What defines a drug interaction?
A reaction between two or more drugs or between a drug and a food, beverage, or supplement.
p.35
Clinical Trials and Serious Adverse Events (SAE)
What does Cumulative Subject Exposure in Clinical Trials refer to?
It indicates the total exposure of subjects to a treatment over the duration of clinical trials.
p.13
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What are patient support programs used for in solicited reports?
They gather structured information on drug efficacy and safety.
p.37
Risk Management Plans (RMP) and Risk Minimization Measures
What is the purpose of the integrated benefit-risk analysis?
To evaluate approved indications for a product.
p.38
Signal Detection and Management
What is the process of signal and risk evaluation?
Assessing safety data to determine potential risks associated with a product.
p.47
Signal Detection and Management
What does the Signal Assessment phase involve?
Evaluating the confirmed signals to make recommendations for action.
p.13
Adverse Drug Reactions (ADR) and Adverse Events (AE)
Give an example of a solicited report.
Reports from post-approval patient use programs or disease management programs.
p.21
Types of Reports: PSUR, PBRER, and DSUR
What does CIOMS VII refer to?
Development safety update reports.
p.4
Good Pharmacovigilance Practices (GVP)
What does MLM stand for?
Medical Literature Monitoring.
p.13
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is the purpose of gathering solicited reports?
To collect information on efficacy or patient compliance.
p.44
Signal Detection and Management
What role does the PRAC play in signal management?
PRAC prioritizes signals for further analysis but may decide that some validated signals do not require immediate action.
p.1
Regulatory Authorities and Guidelines
What is CIOMS?
Council for International Organizations of Medical Sciences.
p.52
Risk Management Plans (RMP) and Risk Minimization Measures
What is the definition of 'Important risk' according to GVP Annex I?
An identified or potential risk that could impact the risk-benefit balance of the product or have implications for public health.
p.45
Signal Detection and Management
What role does medical judgment play in evaluating signals?
It helps determine whether a signal is refuted or should be considered valid.
p.37
Risk Management Plans (RMP) and Risk Minimization Measures
What does ACO stand for?
Addendum to the Clinical Overview.
p.25
Regulatory Authorities and Guidelines
What means are not primarily used to achieve intended actions in the defined medical devices?
Pharmacological, immunological, or metabolic means.
p.4
Clinical Trials and Serious Adverse Events (SAE)
What does PAES stand for?
Post-authorisation efficacy study.
p.33
Types of Reports: PSUR, PBRER, and DSUR
When are PSURs/PBRERs submitted?
At defined time points during the post-authorisation phase.
p.37
Risk Management Plans (RMP) and Risk Minimization Measures
What information does the ACO compile?
All cumulated effectiveness and safety data related to a medicinal product since marketing authorization (MA) or its last renewal.
p.22
Good Pharmacovigilance Practices (GVP)
What is the focus of Module IV?
Pharmacovigilance audits.
p.13
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What role do clinical trials play in the reporting system?
They provide solicited reports of suspect adverse reactions.
p.58
Drug Interactions and Medication Errors
What is a key sign of drug addiction development?
Continuing to consume the drug despite the impairment it causes.
p.46
Signal Detection and Management
What does the signal management process in the EU involve?
Signal assessment by the Pharmacovigilance Risk Assessment Committee (PRAC).
p.41
Good Pharmacovigilance Practices (GVP)
What is the primary goal of medication labeling?
To inform health care stakeholders about medication risks.
p.39
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is included in the late-breaking information in pharmacovigilance?
Relevant updates regarding medication errors and benefits during the evaluation period.
p.3
Signal Detection and Management
What do HLGT and HLT represent?
Higher Level Group Term and High-Level Term, respectively.
p.41
Pharmacovigilance Definition and Objectives
What does periodic reporting facilitate in pharmacovigilance?
Ongoing safety monitoring and risk assessment.
p.46
Signal Detection and Management
What is signal assessment?
The process of further evaluating a validated signal using all available evidence.
p.22
Good Pharmacovigilance Practices (GVP)
What does Module VI Addendum I address?
Duplicate management of suspected adverse reactions reports.
p.58
Drug Interactions and Medication Errors
How can medical conditions affect drug interactions?
Taking a drug while having certain medical conditions can cause a drug interaction.
p.36
Signal Detection and Management
What is the focus of section 16.1?
Summary of Safety Concerns.
p.3
Regulatory Authorities and Guidelines
What is ICH?
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
p.3
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does ICSR represent?
Individual Case Safety Report.
p.36
Risk Management Plans (RMP) and Risk Minimization Measures
What is evaluated in section 16.3?
Risks and New Information.
p.50
Risk Management Plans (RMP) and Risk Minimization Measures
What defines a potential risk according to GVP Annex I (Rev 3)?
An untoward occurrence with some suspicion of association with the medicinal product, but where the association has not been confirmed.
p.40
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What type of reports does the 15-day alert report include?
MedWatch form (3500A) for each ADR not reported as a 15-day expedited report.
p.33
Types of Reports: PSUR, PBRER, and DSUR
What does PBRER stand for?
Periodic Benefit-Risk Evaluation Report.
p.32
Types of Reports: PSUR, PBRER, and DSUR
What does the Data Lock Point (DLP) represent?
The cut-off date for data and analyses presented in a document.
p.30
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is the advantage of Aggregate Reporting?
It provides a broader view of the safety profile of a drug.
p.13
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What distinguishes spontaneous reports from solicited reports?
Spontaneous reports are unsolicited, while solicited reports are gathered through structured systems.
p.32
Types of Reports: PSUR, PBRER, and DSUR
What is a Development Safety Update Report (DSUR)?
A format and content for periodic reporting on drugs under development.
p.49
Risk Management Plans (RMP) and Risk Minimization Measures
How are identified risks usually described and classified?
In the PSUR/PBRER as important or not important.
p.31
Regulatory Authorities and Guidelines
What should a marketing authorization holder do if they have no information on the actual IBD?
Refer to listings of birth dates developed by some regions.
p.47
Signal Detection and Management
What is the Signal Management process?
A set of activities to determine new risks or changes in known risks associated with a medicinal product based on various data sources.
p.39
Regulatory Authorities and Guidelines
What does EU reference date signify?
The date of the first marketing authorisation in the EU of a medicinal product containing a specific active substance or combination.
p.54
Good Pharmacovigilance Practices (GVP)
According to GVP, what constitutes a clinically significant gap?
Gaps in knowledge about safety for certain anticipated utilizations, such as long-term use.
p.49
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What type of studies observe identified risks?
Clinical trials or clinical practice.
p.54
Good Pharmacovigilance Practices (GVP)
What does GVP module V suggest about safety profiles?
There may be insufficient knowledge to determine whether the safety profile differs for particular patient populations.
p.47
Signal Detection and Management
What is Signal Detection?
The process of identifying signals using data from any source.
p.49
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is suggested by well-designed clinical trials regarding identified risks?
A causal relationship compared to the comparator group on a parameter of interest.
p.53
Risk Management Plans (RMP) and Risk Minimization Measures
What factors are evaluated to define the important risks of a medicinal product?
Safety profile, mechanisms of action, epidemiology, risk factors/groups, and available clinical/post-marketing experience.
p.47
Signal Detection and Management
What is Signal Prioritization?
The continuous process of identifying signals suggesting potential important risks.
p.5
Signal Detection and Management
What does 'SMQ' refer to?
Standardised MedDRA query.
p.3
Regulatory Authorities and Guidelines
What does IBD stand for?
International Birth Date.
p.57
Risk Management Plans (RMP) and Risk Minimization Measures
What are post-authorisation obligations?
Conditions imposed as part of the marketing authorization for a medicinal product.
p.53
Risk Management Plans (RMP) and Risk Minimization Measures
What is an important identified risk?
A risk that could impact the risk-benefit balance of the product or have public health implications.
p.46
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What types of data are included in the safety assessment process?
Non-clinical and clinical data.
p.53
Risk Management Plans (RMP) and Risk Minimization Measures
What is an important potential risk?
A risk that, when characterized and confirmed, could impact the risk-benefit balance or public health.
p.46
Regulatory Authorities and Guidelines
What may happen as a major safety-related regulatory action outside the EU?
Restriction of use or suspension of a medicinal product.
p.44
Signal Detection and Management
What tool is used for tracking pharmacovigilance issues in the EU?
European Pharmacovigilance Issues Tracking Tool (EPITT).
p.22
Good Pharmacovigilance Practices (GVP)
What does Module III focus on?
Pharmacovigilance inspections.
p.52
Risk Management Plans (RMP) and Risk Minimization Measures
What should the RMP focus on according to GVP module V?
The important identified risks likely to impact the risk-benefit balance of the product.
p.3
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does FAERS stand for?
FDA Adverse Event Reporting System.
p.51
Good Pharmacovigilance Practices (GVP)
What does GVP module V describe regarding undesirable clinical outcomes?
They may be scientifically suspected to have a causal relationship with the medicinal product.
p.1
Good Pharmacovigilance Practices (GVP)
What is DDPS?
Detailed description of the pharmacovigilance system.
p.31
Regulatory Authorities and Guidelines
What if a product is not included in any listing for IBD?
Propose a birth date based on the earliest known marketing authorization and obtain regulatory authority’s agreement.
p.47
Signal Detection and Management
What are the key activities included in the Signal Management process?
Signal detection, validation, confirmation, analysis and prioritization, assessment, and recommendation for action.
p.39
Regulatory Authorities and Guidelines
When is the EU reference date applicable?
For medicinal products containing the same active substance or combination of active substances.
p.38
Clinical Trials and Serious Adverse Events (SAE)
What type of data is included in summary tabulations?
Summaries of safety and efficacy findings from clinical trials and noninterventional studies.
p.37
Risk Management Plans (RMP) and Risk Minimization Measures
What should the critical discussion in the ACO address?
The current benefit-risk balance based on PSUR data and safety/efficacy data since the granting of the MA or the last renewal.
p.39
Risk Management Plans (RMP) and Risk Minimization Measures
What does benefit evaluation involve?
Assessing the positive effects of a medicinal product.
p.55
Risk Management Plans (RMP) and Risk Minimization Measures
What are typical examples of missing information in medicinal product studies?
Use in pregnant and lactating women or in the pediatric population without adequate clinical studies.
p.47
Signal Detection and Management
What types of data sources are used in the Signal Management process?
Individual case safety reports, aggregated data from surveillance systems, scientific literature, and other data sources.
p.4
Risk Management Plans (RMP) and Risk Minimization Measures
What is PPP in the context of pharmacovigilance?
Pregnancy prevention programme.
p.58
Drug Interactions and Medication Errors
Give an example of a drug interaction.
Taking a nasal decongestant if you have high blood pressure may cause an unwanted reaction.
p.4
Regulatory Authorities and Guidelines
What does PRAC stand for?
Pharmacovigilance and Risk Assessment Committee.
p.58
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is drug addiction?
A disease that negatively affects a person's brain and behavior.
p.4
Signal Detection and Management
What is the meaning of PRR?
Proportional reporting ratio.
p.56
Risk Management Plans (RMP) and Risk Minimization Measures
Where are the safety concerns of a medicinal product identified and monitored?
In the DSUR, RMP, and PSUR/PBRER.
p.35
Clinical Trials and Serious Adverse Events (SAE)
What does the term 'Completed Clinical Trials' signify?
Trials that have finished and have no further subjects enrolled.
p.35
Clinical Trials and Serious Adverse Events (SAE)
What distinguishes Ongoing Clinical Trials?
They are still in progress with active subject enrollment.
p.56
Risk Management Plans (RMP) and Risk Minimization Measures
What is the purpose of the RMP?
To reflect the increasing knowledge on risks and benefits and post-marketing experience.
p.36
Clinical Trials and Serious Adverse Events (SAE)
What type of findings are discussed in section 8?
Findings from Non-interventional Studies.
p.35
Clinical Trials and Serious Adverse Events (SAE)
What does Estimated Exposure and Use Patterns indicate?
It refers to estimates of how many patients have used a product over a period.
p.36
Signal Detection and Management
What type of information is provided in section 14?
Late-Breaking Information.
p.51
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What indicates the possibility of a causal association to a medicinal product?
Preclinical or clinical considerations, even if potential risks have not been observed.
p.4
Types of Reports: PSUR, PBRER, and DSUR
What does PBRER mean?
Periodic benefit-risk evaluation report.
p.13
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What are non-interventional studies used for in pharmacovigilance?
They are a source for solicited reports regarding suspect adverse reactions.
p.42
Signal Detection and Management
What aspects may indicate a new signal in an adverse reaction?
Changes in frequency, distribution, duration, severity, or outcome.
p.5
Regulatory Authorities and Guidelines
What is the 'SmPC'?
Summary of product characteristics.
p.37
Risk Management Plans (RMP) and Risk Minimization Measures
What types of data are evaluated in the benefit-risk analysis?
PSUR data and accumulated safety/efficacy data.
p.57
Risk Management Plans (RMP) and Risk Minimization Measures
What should be documented to prevent or minimize risks associated with a medicinal product?
Measures and an assessment of the effectiveness of those interventions.
p.38
Signal Detection and Management
What does an overview of signals include?
Identification and evaluation of new safety signals related to the medicinal product.
p.46
Signal Detection and Management
What does signal assessment aim to determine?
Whether there are new risks or changes in known risks associated with a medicinal product.
p.22
Good Pharmacovigilance Practices (GVP)
What is the focus of Module VII?
Periodic safety update report.
p.35
Good Pharmacovigilance Practices (GVP)
What type of information is included in Reference Information?
It encompasses key safety and efficacy data about the medicinal product.
p.22
Good Pharmacovigilance Practices (GVP)
What is covered in Module VIII?
Post-authorisation safety studies.
p.56
Risk Management Plans (RMP) and Risk Minimization Measures
What does a safety concern refer to in pharmacovigilance?
An important identified risk, important potential risk, or missing information.
p.37
Risk Management Plans (RMP) and Risk Minimization Measures
What is the final outcome expected from the ACO?
A new renewal for the medicinal product.
p.55
Risk Management Plans (RMP) and Risk Minimization Measures
How is the risk-benefit balance of a medicinal product monitored?
Through pharmacovigilance activities and periodical safety reports like DSURs and PBRERs.
p.22
Good Pharmacovigilance Practices (GVP)
What does Module IX Addendum I discuss?
Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions.
p.36
Risk Management Plans (RMP) and Risk Minimization Measures
What does section 17.3 focus on?
Characterisation of Benefits.
p.35
Good Pharmacovigilance Practices (GVP)
What changes may occur to Reference Safety Information?
Updates to safety data based on new findings or adverse event reports.
p.55
Risk Management Plans (RMP) and Risk Minimization Measures
How is the decision made regarding critical missing information in a specific population?
Based on clinical considerations.
p.42
Signal Detection and Management
How are signals monitored and evaluated?
Continuously by the company.
p.38
Good Pharmacovigilance Practices (GVP)
What information should the Addendum to the Clinical Overview contain?
Relevant safety and efficacy data affecting the benefit-risk assessment.
p.35
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What are Cumulative Summary Tabulations of Serious Adverse Events?
They provide a summary of serious adverse events recorded during clinical trials.
p.5
Regulatory Authorities and Guidelines
What is the role of the 'USFDA'?
United States Food & Drug Administration.
p.4
Types of Reports: PSUR, PBRER, and DSUR
What does PSUR stand for?
Periodic safety update report.
p.36
Clinical Trials and Serious Adverse Events (SAE)
What type of information does section 17.1 contain?
Important Baseline Efficacy/Effectiveness Information.
p.56
Risk Management Plans (RMP) and Risk Minimization Measures
What must the risk management plan established by the marketing authorization holder contain?
A detailed description of the risk management system.
p.36
Clinical Trials and Serious Adverse Events (SAE)
What type of information is covered in section 9?
Information from Other Clinical Trials and Sources.
p.35
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does Data in Summary Tabulations represent?
Compiled data showcasing findings from studies and reported adverse events.
p.36
Signal Detection and Management
What does section 16 cover in relation to signals?
Signal and Risk Evaluation.
p.37
Risk Management Plans (RMP) and Risk Minimization Measures
What is included in the appendices of the ACO?
Relevant additional information and data supporting the benefit-risk evaluation.
p.55
Risk Management Plans (RMP) and Risk Minimization Measures
What is the risk-benefit balance?
An evaluation of the positive therapeutic effects of a medicinal product in relation to its associated risks.
p.37
Risk Management Plans (RMP) and Risk Minimization Measures
What is the first step in the benefit-risk context evaluation?
Discussing medical need and important alternatives.
p.22
Good Pharmacovigilance Practices (GVP)
What does Module VIII Addendum I provide?
Requirements and recommendations for submission of information on non-interventional post-authorisation safety studies.
p.36
Risk Management Plans (RMP) and Risk Minimization Measures
What does section 16.4 discuss?
Characterisation of Risks.
p.56
Regulatory Authorities and Guidelines
What does the ICH-E2E Guideline refer to safety concerns as?
Safety issue, used interchangeably with the same definition.
p.42
Signal Detection and Management
What may justify verificatory action regarding a signal?
A sufficient likelihood of a new potentially causal association.
p.36
Clinical Trials and Serious Adverse Events (SAE)
What is highlighted in section 17.2?
Newly Identified information on Efficacy/Effectiveness.
p.35
Risk Management Plans (RMP) and Risk Minimization Measures
What type of actions are taken in the Reporting Interval for Safety Reasons?
Any measures implemented to address safety concerns identified during a specific time frame.
p.56
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is the relationship between safety concerns and post-marketing experience?
Safety concerns are monitored in relation to post-marketing experience.
p.5
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What does 'SUSAR' stand for?
Suspected Unexpected Serious Adverse Reaction.
p.42
Types of Reports: PSUR, PBRER, and DSUR
What types of signals are presented in the PSUR/PBRER?
New signals that emerge, remain ongoing, or are closed during the reporting period.
p.55
Risk Management Plans (RMP) and Risk Minimization Measures
What does the risk-benefit balance evaluate?
The positive effects in relation to risks related to quality, safety, or efficacy concerning patient or public health.
p.4
Good Pharmacovigilance Practices (GVP)
What does PSMF stand for?
Pharmacovigilance system master file.
p.36
Risk Management Plans (RMP) and Risk Minimization Measures
What is assessed in section 16.5?
Effectiveness of Risk Minimisation (if applicable).
p.56
Risk Management Plans (RMP) and Risk Minimization Measures
What is a Risk Management Plan (RMP)?
A dynamic document that should be updated throughout the life-cycle of the medicinal product.
p.35
Clinical Trials and Serious Adverse Events (SAE)
What are Other Therapeutic Uses of Medicinal Products?
Additional approved uses of a product beyond its primary indication.
p.56
Types of Reports: PSUR, PBRER, and DSUR
What is PSUR?
Periodic Safety Update Report.
p.42
Signal Detection and Management
What defines a signal in pharmacovigilance?
Information suggesting a new potentially causal association or a new aspect of a known association between an intervention and an event.
p.5
Regulatory Authorities and Guidelines
What is the 'WHO'?
World Health Organization.
p.5
Good Pharmacovigilance Practices (GVP)
What does 'xEVMPD' stand for?
eXtended EudraVigilance Medicinal Product Dictionary.
p.35
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What is the significance of New Safety Data Related to Fixed Combination Therapies?
It relates to safety findings impacting medications composed of multiple active ingredients.
p.56
Types of Reports: PSUR, PBRER, and DSUR
What are PBRERs?
Periodic Benefit-Risk Evaluation Reports.
p.35
Clinical Trials and Serious Adverse Events (SAE)
What are Summaries of Significant Findings from Clinical Trials?
Key results and safety findings observed during the reporting period.
p.35
Adverse Drug Reactions (ADR) and Adverse Events (AE)
What do Cumulative and Interval Summary Tabulations from Post-marketing Data Sources include?
They summarize adverse events reported after a drug has been marketed.
p.42
Signal Detection and Management
What sources can contribute to a signal?
Observations and experiments.
p.35
Clinical Trials and Serious Adverse Events (SAE)
What is meant by Long-term Follow-up in clinical research?
Monitoring subjects for extended periods after trial completion to assess long-term effects.
p.56
Clinical Trials and Serious Adverse Events (SAE)
What does DSUR stand for?
Development Safety Update Report.
p.36
Clinical Trials and Serious Adverse Events (SAE)
What issue does section 13 address?
Lack of Efficacy in Controlled Clinical Trials.
p.36
Signal Detection and Management
What overview is provided in section 15?
Overview of Signals: New, Ongoing, or Closed.
