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Glossary

Unexpected Adverse Drug Reaction

An adverse reaction whose nature, severity, specificity, or outcome is not consistent with the description given in product labelling or market authorization (USPI in the US, SmPC in Europe).

New MoCRA Adverse Event Reporting Requirements: Impact on the Cosmetic Industry

Abbreviated New Drug Application (ANDA)

Abridged Application

Absolute Risk

Abuse

Academia

Acceptable Risk

Active Pharmaceutical Ingredient (API)

Active Substance

Active Substance Master File (ASMF)

Active Surveillance System

Adaptive Clinical Trial

Additional Risk Minimisation Measure

Adjuvant

ADME Study

Adoption

Adverse Drug Reaction (ADR)

Adverse Event (AE)

Adverse Event of Special Interest (AESI)

AGREE Instrument

Alert

Amendment

Analysis Data Model (AdAM)

Analysis Datasets

Analysis of covariance (ANCOVA)

Anatomical Therapeutic Chemical Classification System (ATC)

Annotated Case Report Form

Annotated ECG waveform data

Annual Report

Applicant

Application Number

Approval Letter

Arm

Artificial Intelligence (AI)

ASEAN Common Technical Document (ACTD)

Association

Audit Certificate

Auditor

Baseline characteristics

Bayesian

Bayesian confidence propagation neural network (BCPNN)

Benefit

Benefit-Risk Assessments

Benefit-Risk Balance (Effectiveness/Risk)

Binary Analysis

Bioavailability

Biologic Product

Biologics License Applications (BLA)

Biomarker

Blinding / Masking

Bonferroni Correction

Boxed warning (“black box warning”)

Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

Burden of a risk minimisation activity

Burden to patients

Candidate gene study

Caregiver

Case Report Form

Case report form (CRF)

Case Reports

Causal Relationship

Causality Assessment

Causality assessment

CE Mark (CE)

Censored/Censoring of Data

Center for Biologics Evaluation and Research (CBER)

Center for Devices and Radiological Health (CDRH)

Center for Drug Evaluation and Research (CDER)

Centralised Procedure (CP)

Centrally-Authorised Procedure (CAP)

Certificate of Suitability (CEP)

Certified Copy

Checksum

Chemical Abstracts Service Registry Number (CAS Number)

Chemistry, Manufacturing and Controls (CMC)

Clinical Data Interchange Standards Consortium (CDISC)

Clinical Development Program

Clinical Study

Clinical Study Report

Clinical Trial Applications (CTA)

Clinical Trial Authorization (CTA)

Clinicaltrials.gov

CMC Supplement

Code of Federal Regulations (CFR)

Combination Product

Commitment

Committee for Medicinal Products for Human Use (CHMP)

Common Technical Document (CTD)

Company Core Data Sheet (CCDS)

Company Core Safety Information (CCSI)

Comparator

Competent Authority

Complete Response Letter

Concerned Member State (CMS)

Contract Research Organization (CRO)

Control

Controlled Study

Controlled Vocabulary

Core Data Sheet (CDASH)

Corrective And Preventative Action (CAPA)

Council for International Organizations of Medical Sciences (CIOMS)

Critical Terms

Crossover Study

DailyMed

Data Definition File

Data Listings

Data Lock Point (DLP)

Data Monitoring Committee

Data Monitoring Committee (DMC)

Data Tabulation Datasets

Decentralised Procedure (DCP)

Dechallenge

Define.xml

Designated Medical Event (DME)

Development core safety information (DCSI)

Development pharmacovigilance and risk management plan

Development Safety Update Report (DSUR)

Developmental International Birth Date (DIBD)

Device

Digital Application Dataset Integration (DADI)

Digital Signature

Disproportionality Analysis

Document Type Definition (DTD)

Dosage Form

Dosage Strength

Dose

Dose-Ranging Study

Double-Blind Research Design

Dropout

Drug Abuse

Drug Master File (DMF)

Drug Product (DP)

Drug Substance (DS)

eCopy

eCTD Backbone

eCTD Validation Criteria

Efficacy

Efficacy Supplement

Electronic Application Form (eAF)

Electronic Data Capture (EDC)

Electronic Patient Reported Outcome (ePRO)

Electronic Signature

Electronic Submissions Gateway (ESG)

Endpoint

Enrollment

Envelope

EUDRAGENE

EudraVigilance

European Directorate for the Quality of Medicines (EDQM)

European Economic Area (EEA)

European Medicines Agency (EMA)

Excipient

Exclusion Criteria

Expected Adverse Drug Reaction

Expedited Reporting

eXtended EudraVigilance Medicinal Dictionary (XEVMPD)

eXtended EudraVigilance Product Report Message (XEVPRM)

Fast Healthcare Interoperability Resources (FHIR)

FDA 1571

FDA 1572

FDA 2253

FDA 356h

File Tag

Food and Drug Administration (FDA)

Frequency of ADRs

Generic Drug

Global Trade Item Number (GTIN)

Good Clinical Practice (GCP)

Good Pharmacovigilance Practice

Grouped Submission

Guidance

Gulf Co-operation Council (GCC)

Harm

Hazard

Health Authority (HA)

Health Canada

ICH

ICH E3

Identification of Medicinal Products (IDMP)

Identified Risk

Important Medical Event (IME)

Important Protocol Deviation

Important Risk

Incidence

Inclusion Criteria

Independent Ethics Committee

Indication

Informed Consent

Informed consent form (ICF)

Inspection

Inspector

Institutional Review Board (IRB)

Integrated Summary of Efficacy (ISE)

Integrated Summary of Safety (ISS)

Interim Analysis

Intermediate (or Intermediate Product)

International Birth Date (IBD)

International Council for Harmonisation (ICH)

International Nonproprietary Name (INN)

International Organization for Standardization (ISO)

International Serious Adverse Events Consortium (SAEC)

Interventional Study (Clinical Trial)

Investigation New Drug Application (IND)

Investigational Drug

Investigational Medicinal Product Dossier (IMPD)

Investigational New Drug Application (IND)

Investigational Product (IP)

Investigational Site

Investigator

Investigator’s Brochure (IB)

Label

Labeling Supplement

Labelling

Leaf Element

Leaf Title

Lifecycle Operations

Lost to Follow Up

Manufacturing Supplement

Marketing Authorisation Application (MAA)

Marketing Authorisation Holder (MAH)

Medical Device

Medical Dictionary for Regulatory Activities (MedDRA)

Medication Error

Medicines and Healthcare products Regulatory Agency (MHRA)

Minimum Criteria for Reporting

Missing Information

Module 1

Module 2

Module 3

Module 4

Module 5

Monitoring

Monitoring Visit

Monitoring Visit Report

Multicenter Trial

Mutual Recognition Procedure (MRP)

National Competent Authority (NCA)

National Pharmacovigilance Centers or National Competent Authority (NCA)

Nationally Authorised Product (NAP)

NCT Number

Near-Misses

New Drug Application (NDA)

Node Extension

Non eCTD Electronic Submission (NeeS)

Novel Excipient

Number Needed to Harm (NNH)

Observational Study

Odds and Odds Ratio

Off-Label Use or Misuse

Organisation Management Service (OMS)

Orphan Drug

Overdose

Packaged Medicinal Product Identifier (PCID)

Patient Package Insert (PPI)

Patient Registry

Patient-Reported Outcome (PRO)

Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER)

Pharmaceuticals and Medical Devices Agency (PMDA)

Pharmacoepidemiology

Pharmacokinetics

Pharmacology

Pharmacopoeia

Pharmacovigilance

Pharmacovigilance Master File

Pharmacovigilance Risk Assessment Committee (PRAC)

Pharmacovigilance System

Phase

Phase 0 (aka Early Phase 1)

Phase 1

Phase 2

Phase 3

Phase 4

Pivotal Clinical Trial

Placebo

Plasma Master File (PMF)

Post-Authorization Safety Study (PASS)

Postmarketing Surveillance

Potential Risk

Predicate Rule

Predisposing Factors

Prescription Event Monitoring (PEM)

President’s Emergency Plan for AIDS Relief (PEPFAR)

Prevalence

Principal Investigator

Priority Review

Protocol

Protocol Amendment

Protocol Deviation

QPPV

Qualified Person Responsible For Pharmacovigilance (QPPV)

Quality Overall Summary (QOS)

Query

Randomization

Randomized Allocation

Rapporteur

Rational Drug Use

Real World Studies

Rechallenge

Recruitment

Reference Listed Drug

Reference Member State (RMS)

Resources

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