This bingo card has a free space and 130 words: Important Potential Risks, Subject Matter Expert, Occupational exposure, Medicines and Healthcare Regulatory Agency, Side effect, Medical Dictionary for Regulatory Activities (MedRA), Clinical Study, EudraVigilance, GVP Module I, Post-authorization Safety Study, Serious Adverse Event, Monitoring Plan, Pharmacovigilance, Aggregate Safety Report (ASR), Signal Management Process, Signal Validation, Health Authority, BeiGene Representative, Patient Safety, Quality Assurance, process excellence, Good Pharmacovigilance Practice, Contract Research Organization (CRO), Organized Data Collection Program, Safety Management Team, Investigator, Investigational Medicinal Product, Clinical Study Number, Signal Prioritization, Benefit-risk analysis, PV Agreement, Non-Interventional Study, Product Safety Strategy, Affiliate, Adverse Event Report Number, Company Core Safety Information, Local Safety Representative, Good Clinical Practice, Product, Marketing Authorization Holder, Off-label use, Adverse Event (AE), Risk Management, Dear Investigator Letter, Global Patient Safety, Adverse Drug Reaction (ADR), Individual Case Safety Report (ICSR), Business Partner, Periodic Benefit-Risk Evaluation Report, Product Quality Complaint, Data Lock Point, Literature Report, National Medical Product Administration, Urgent Safety Measure, Expectedness, Healthcare Professional, Informed Consent, Company Core Data Sheet, Overdose, Reference Safety Information, Sponsor, Institutional Review Board, Tolerability, International Conference on Harmonization (ICH), Solicited reports, Other Safety Issue, Protocol, Special Situations, Risk Communication, Global Safety Database, Pharmacoepidemiology, Risk Management Plan, Pharmacovigilance, Periodic Safety Update Report, Interventional Study, periodic safety update report (PSUR), Comparator Product, Qualified Person for Pharmacovigilance, Country Safety Lead/Manager, Council for International Organizations of Medical Sciences, Signal Detection, Blinding or Masking, Company Safety Committee, Causality Assessment, Drug Abuse, Adverse Event of Special Interest (AESI), Identified Risk, Drug Adverse Event Reporting System, Individual Case Safety Report, Quality Management System (QMS), Safety Signal, Post-Marketing Surveillance, Development Safety Update Report, Refuted Signal, Clinical Trial Application, World Health Organization, Spontaneous (Unsolicited) report, Pharmacovigilance System Master File, Unexpected Events, Safety Data Exchange Agreement, Regulatory authority, Risk-Benefit Balance, Drug Product, Non-serious AESI, background rates, Listedness/ expectedness, Safety Assessment Team, Validated Signal, New Drug Application, Signal Assessment, Safety Information, Developmental Risk Management Plan, alliance management, Observational study, Signal Detection Plan, Non-validated signal, Drug Substance, Chief Safety Officer, Suspected Unexpected Serious Adverse Reaction (SUSAR), Corrective and Preventive Action (CAPA), Investigator’s Brochure, Business Continuity Plan, Labeled or unlabeled, Clinical Trial, Development International Birth Date, Pharmacovigilance System, Product Recall, Investigational New Drug Application, Clinical Development Program and Medical Review.
⚠ This card has duplicate items: Pharmacovigilance (2)
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