Pediatrics, Geriatrics, Pregnancy, Lactation

This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.

The WHO International Drug Monitoring Program was established in 1963 in response to the thalidomide disaster. It currently has 143 member countries that submit adverse drug reaction reports to the global pharmacovigilance database VigiBase managed by the Uppsala Monitoring Centre (UMC) as a WHO collaborating center. The UMC analyzes VigiBase data to identify new safety signals, conducts research, and provides tools and training to support member countries' pharmacovigilance activities. The overall goals are to identify unknown adverse drug reactions and ensure medicines are used safely worldwide.

GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

Defined daily dose-DDD B Pharm, Pharm D and medicine syllabus Useful for examination and regulatory function information Useful for Pharmacovigilance interview and medical coding also. Good Luck and all the best!!!

1. Pharmacovigilance 2. Pathway of PvPI 3. Establishment of PV Programme in Hospital 4. Establishment of PV Programme in Industry 5. Contract Research Organization 6. Establishment a National Programme

Active Surveillance, Passive Surveillance, Comparative observational methods, stimulated reporting, targeted clinical investigations

Regulatory requirements for new drug approval are in place to ensure medications are safe and effective for consumers. Regulatory affairs evaluate drug development, production, and marketing. Key functions include monitoring legislation changes and ensuring manufacturing and marketing practices comply with regulations. Stringent approval processes were implemented after tragic incidents revealed drug safety issues. Notable regulatory bodies include the FDA in the US and CDSCO in India. Approval involves non-clinical and clinical trials to assess safety, efficacy, and quality before marketing applications like an NDA can be submitted for review. Compliance with regulatory standards is necessary throughout the drug development and approval process.

Pharmacy Practice for Final Year B.Pharmacy Sem-VII, As per PCI Syllabus Investigational use of drugs

The document discusses various methods used in pharmacovigilance including spontaneous reporting systems, case series, stimulated reporting, active surveillance methods like sentinel sites and drug event monitoring, use of registries, observational studies like cross-sectional, case-control and cohort studies, targeted clinical investigations and descriptive studies. It also outlines the key aims and shared responsibilities of pharmacovigilance among drug companies, regulatory authorities, doctors, pharmacists and nurses.