SHORT Notes

TOPIC Key Learning Points
United States of America (USA)
  • Food and Drug Administration (FDA)
  • Responsibilities of FDA
  • Products regulated by FDA   
  • Vaccine Adverse Event Reporting System (VAERS) 
  • FDA Adverse Event Reporting System (FAERS) 
  • Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA Regulations, and FDA Guidance
  • Centers for Disease Control and Prevention (CDC)   
  • National Institutes of Health (NIH) 
  • Health and Human Services (HHS)  
India
  • Central Drugs Standard Control Organization (CDSCO)
  • Indian Pharmacopoeia Commission (IPC)
  • Pharmacovigilance Programme of India (PvPI)
  • Materiovigilance Programme of India (MvPI) 
  • Haemovigilance Programme of India (HvPI) 
World Health Organization (WHO)
  • World Health Organization (WHO)
  • WHO Programme for International Drug Monitoring (WHO PIDM)
  • VigiBase,  VigiFlow,   VigiAccess,   VigiLyze,   
  • WHO Drug Global   
  • WHO Drug Information 
European Medicines Agency (EMA)
  • European Medicines Agency (EMA)
  • EudraVigilance Authorization of Medicines in the European Union (EU)
  • Centralized Authorization Procedure Scope of Centralized Procedure
  • National Competent Authority (Human)
  • Mutual Recognition Procedure (MRP)
  • Decentralized Procedure (DCP)
  • European Commission
  • European Medicines Regulatory Network 
  • EMA - Organization
  • Referral Procedure
International Council for Harmonization (ICH)
  • International Council for Harmonization  
  • Organization of ICH 
  • ICH Guidelines
  • Common Technical Document (CTD)
CIOMS - Council for International Organizations of Medical Sciences
  • Council for International Organizations of Medical Sciences (CIOMS) 
  • CIOMS Forms
  • CIOMS Working Groups (WGs)
  • CIOMS Members
Vaccine
  • Vaccine
  • How do vaccines differ from drugs?
  • How do vaccines work?
  • Different approaches to developing vaccines
  • The whole-microbe approach
  • The subunit approach
  • The genetic approach (Nucleic acid vaccine)
  • Types of Vaccines
  • Live-attenuated vaccines
  • Inactivated vaccines
  • Viral vector vaccines
  • Subunit vaccines
  • Protein-based vaccines
  • Polysaccharide vaccines
  • Conjugate vaccines
  • Toxoid vaccines
  • mRNA vaccines
  • DNA vaccines
  • Vaccine ingredients
Medical Device
  • Medical Devices
  • Classification of Medical devices
  • Class I Medical devices
  • Class II Medical devices
  • Class III Medical devices
Regulatory Authorities of Different Countries 
  • Food and Drug Administration (FDA)
  • European Medicines Agency (EMA)
  • Therapeutic Goods Administration (TGA)
  • Central Drugs Standard Control Organisation(CDSCO)
  • PMDA (Pharmaceuticals and Medical Devices Agency)
  • Health Canada
  • Medicines and Healthcare products Regulatory Agency (MHRA)
  • South African Health Products Regulatory Authority (SAHPRA)
Databases of Different Countries
  • VigiFlow
  • VigiBase
  • FDA Adverse Event Reporting System (FAERS)
  • Vaccine Adverse Event Reporting System (VAERS)
  • EudraVigilance
  • Database of Adverse Event Notifications (DAEN)
  • Canada Vigilance Adverse Reaction Online Database
  • Japanese Adverse Drug Event Report (JADER) database 
Aggregate Reports
  • Aggregate Reports
  • Importance of Aggregate reports
  • Development Safety Update Report (DSUR)
  • Periodic Safety Update Report (PSUR)
  • Periodic Benefit Risk Evaluation Reports (PBRERs)
  • PSUR vs PBRER
  • PSUR/PBRER - Submission timeline
  • Periodic Adverse Drug Experience Reports (PADERs/PAERs)
  • PBRER Vs. PADER
  • DSUR, PSUR/PBRER, PADER -Submission timelines

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