Explore topic-wise InterviewSolutions in .

• USA: United States Food and drug administration (USFDA).
• UK: European Medicines Agency (EMEA).
• Japan: Ministry of Health, Labour and WELFARE (MHLW).
• India: CENTRAL DRUGS Standard Control Organization (CDSCO)

If an EVENT is ASSOCIATED with any ONE of the following, it is CONSIDERED to be serious

• Death
• LIFE threatening
• Hospitalization or prolongation of hospitalization.
• Congenital anomaly
• Disability
• Medically significant

If an event is associated with any one of the following, it is considered to be serious

Two types. 1. Active PV and 2.Passive PV

Active PV: Active (or proactive) safety surveillance MEANS that active measures are taken to detect adverse events. This is managed by active follow-up after treatment and the events may be detected by asking patients directly or screening patient records. The most comprehensive method is cohort event MONITORING (CEM)

Passive PV: Passive surveillance means that no active measures are taken to look for adverse effects other than the encouragement of health professionals and others to report safety concerns. Reporting is dependent on the INITIATIVE and MOTIVATION of the potential reporters. This is the most common form of pharmacovigilance. It is commonly referred to as “spontaneous” or “voluntary” reporting.

Two types. 1. Active PV and 2.Passive PV

Active PV: Active (or proactive) safety surveillance means that active measures are taken to detect adverse events. This is managed by active follow-up after treatment and the events may be detected by asking patients directly or screening patient records. The most comprehensive method is cohort event monitoring (CEM)

Passive PV: Passive surveillance means that no active measures are taken to look for adverse effects other than the encouragement of health professionals and others to report safety concerns. Reporting is dependent on the initiative and motivation of the potential reporters. This is the most common form of pharmacovigilance. It is commonly referred to as “spontaneous” or “voluntary” reporting.

Data assessments are:

• Individual CASE report assessment
• Aggregated assessment and INTERPRETATION
• Signal detection
• Interactions and risk factors
• Serial study
• Frequency
• Estimation

Data assessments are:

E2a: E2a guidelines give standard DEFINITIONS and terminology for key aspects of clinical safety reporting. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug REACTIONS in the investigational phase of drug development.

E2b: E2b guidelines for the MAINTENANCE of clinical safety DATA management and information about the data elements for TRANSMISSION of Individual Case Safety Reports.

E2c: E2b guidelines for the maintenance of clinical safety data management and information about the Periodic Safety Update Reports for marketed drugs.

E2a: E2a guidelines give standard definitions and terminology for key aspects of clinical safety reporting. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development.

E2b: E2b guidelines for the maintenance of clinical safety data management and information about the data elements for transmission of Individual Case Safety Reports.

E2c: E2b guidelines for the maintenance of clinical safety data management and information about the Periodic Safety Update Reports for marketed drugs.

• System Organ Class (SOC)
• HIGH Level Group TERM (HLGT)
• High Level Term (HLT)
• Preferred Term (PT)
• Lower Level Term (LLT)

MEDICAL DICTIONARY for REGULATORY ACTIVITIES.

Medical Dictionary for Regulatory Activities.

A narrative should consist of PRECISE and concise information about the source of report, patient demographics, patient’s medical history, concomitant MEDICATIONS, suspect product details and adverse event details in an ORDERLY manner.

A narrative should consist of precise and concise information about the source of report, patient demographics, patient’s medical history, concomitant medications, suspect product details and adverse event details in an orderly manner.

PATIENT demographics: Age, gender and race.

Suspect product details: DRUG, dose, dosage form, therapy dates, therapy duration and indication. Adverse event details: Event, event ONSET date, seriousness criterion, event END date and LATENCY.

Patient demographics: Age, gender and race.

Suspect product details: Drug, dose, dosage form, therapy dates, therapy duration and indication. Adverse event details: Event, event onset date, seriousness criterion, event end date and latency.

CAUSALITY is the relationship between a set of FACTORS. In Pharmacovigilance, causality is the relationship between the suspect product and the ADVERSE DRUG EVENT.

Causality is the relationship between a set of factors. In Pharmacovigilance, causality is the relationship between the suspect product and the adverse drug event.

A case is CONSIDERED to be medically CONFIRMED if it contains at least one event confirmed or reported by an HCP (Health CARE Professional)

Note: HCP can be a physician, nurse, PHARMACIST, coroner or psychologist (only in GERMANY).

A case is considered to be medically confirmed if it contains at least one event confirmed or reported by an HCP (Health Care Professional)

Note: HCP can be a physician, nurse, pharmacist, coroner or psychologist (only in Germany).

Volume 9A brings together GENERAL guidance on the requirements, PROCEDURES, roles and activities in the field of pharmacovigilance, for both Marketing Authorisation Holders (MAH) and Competent Authorities of medicinal products for human use; it incorporates international agreements reached WITHIN the framework of the International Conference on Harmonisation (ICH).

Volume 9A is presented in four parts:

• Part I deals with Guidelines for Marketing Authorisation Holders;
• Part II deals with Guidelines for Competent Authorities and the Agency;
• Part III provides the Guidelines for the electronic exchange of pharmacovigilance in the EU
• Part IV provides Guidelines on pharmacovigilance COMMUNICATION

Volume 9A brings together general guidance on the requirements, procedures, roles and activities in the field of pharmacovigilance, for both Marketing Authorisation Holders (MAH) and Competent Authorities of medicinal products for human use; it incorporates international agreements reached within the framework of the International Conference on Harmonisation (ICH).

Volume 9A is presented in four parts:

There MAY not be a causal RELATIONSHIP between a DRUG and an ADE, whereas, there is a causal link between a drug and an adverse drug reaction.

There may not be a causal relationship between a drug and an ADE, whereas, there is a causal link between a drug and an adverse drug reaction.

An adverse drug reaction is a “RESPONSE to a drug which is noxious and unintended and which occurs at doses normally used in MAN for prophylaxis, diagnosis, or therapy of disease or for the modification of PHYSIOLOGIC function.” Note that there is a causal link between a drug and an adverse drug reaction. In sum, an adverse drug reaction is HARM directly caused by the drug at normal doses, during normal use.

An adverse drug reaction is a “response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function.” Note that there is a causal link between a drug and an adverse drug reaction. In sum, an adverse drug reaction is harm directly caused by the drug at normal doses, during normal use.

Any untoward medical OCCURRENCE in a patient or clinical INVESTIGATION subject administered a PHARMACEUTICAL PRODUCT and which does not necessarily have to have a causal RELATIONSHIP with this treatment.

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

• An identifiable REPORTER
• An identifiable PATIENT
• A suspect PRODUCT
• An ADVERSE DRUG event

Pharmacovigilance is the science of collecting, monitoring, researching, assessing and EVALUATING information from healthcare providers and patients on the adverse effects of MEDICATIONS, biological PRODUCTS, HERBALISM and traditional MEDICINES

Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines