The WHO Program for International Drug Monitoring (PIDM) was established in 1963 to systematically collect information on serious adverse drug reactions. It has grown from 10 founding members to 176 total member countries. The Uppsala Monitoring Centre serves as the WHO Collaborating Centre and maintains the global database VigiBase, where member countries submit adverse reaction reports. The PIDM aims to identify new safety issues, facilitate information exchange, and provide resources to support pharmacovigilance globally.
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Guidelines of ADR reporting are mentioned. Where to report? How to report? Whom to report? These are the major part of the ppt. Normal people can understand about the drug safety process.
Guidelines for Preparation of Documents, Clinical Study Report Clinical Trial...Dinesh Gangoda
Contents
Guidelines for Preparation of Documentation
Clinical Study Reports
Clinical Trial Monitoring
Safety Monitoring in clinical trials
Introduction
Proper documentation is critical to the success of a clinical study.
Every aspect of the study must be documented in order to obtain useful data and demonstrate compliance with Good Clinical Practice (GCP) guidelines and with all applicable regulations.
Investigator’s Brochure (IB)
List of Abbreviations
Contents & Summary
Introduction provides the chemical name (and generic and trade names, if approved) of the investigational product.
Physical, chemical and pharmaceutical properties and formulation of the medicinal product. Non-clinical studies & Clinical Studies and their results.
The Investigator's Brochure should be reviewed at least annually and revised as necessary in compliance with a standard procedures established by drug development company.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Establishment of Pharmacovigilance ProgrammeNipun Gupta
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
WHO AND PHARMACOVIGILANCE (Clinical Research & Pharmacovigilance.pptxDureshahwar khan
This presentation includes introduction to WHO International Drug Monitoring Program & its functions, Role of WHO in PV, Vigibase, regulatory terminology of ADR and evaluation of medication safety.
Guidelines of ADR reporting are mentioned. Where to report? How to report? Whom to report? These are the major part of the ppt. Normal people can understand about the drug safety process.
Guidelines for Preparation of Documents, Clinical Study Report Clinical Trial...Dinesh Gangoda
Contents
Guidelines for Preparation of Documentation
Clinical Study Reports
Clinical Trial Monitoring
Safety Monitoring in clinical trials
Introduction
Proper documentation is critical to the success of a clinical study.
Every aspect of the study must be documented in order to obtain useful data and demonstrate compliance with Good Clinical Practice (GCP) guidelines and with all applicable regulations.
Investigator’s Brochure (IB)
List of Abbreviations
Contents & Summary
Introduction provides the chemical name (and generic and trade names, if approved) of the investigational product.
Physical, chemical and pharmaceutical properties and formulation of the medicinal product. Non-clinical studies & Clinical Studies and their results.
The Investigator's Brochure should be reviewed at least annually and revised as necessary in compliance with a standard procedures established by drug development company.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Establishment of Pharmacovigilance ProgrammeNipun Gupta
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
WHO AND PHARMACOVIGILANCE (Clinical Research & Pharmacovigilance.pptxDureshahwar khan
This presentation includes introduction to WHO International Drug Monitoring Program & its functions, Role of WHO in PV, Vigibase, regulatory terminology of ADR and evaluation of medication safety.
PHARMACOVIGILANCE_SLIDE. Insight to pharmacovigilance, covering basics and va...ssharmapharmacy005
Insight to pharmacovigilance,
covering basics and various aspects, case processing types of ADR, basic terminologies
adr reporting dverse vent, types of adr, meddra
History and Progress of Pharmacovigilance, Significance of Safety Monitoring, Pharmacovigilance in India And International Aspects, WHO International Drug Monitoring Programme, WHO and Regulatory Terminologies of ADR, Evaluation of Medication Safety, Establishing Pharmacovigilance Centres in Hospitals, Industry and National Programmes Related to Pharmacovigilance, Roles and Responsibilities in Pharmacovigilance, International Non-Proprietary Names for Drugs, International Classification of Diseases, Passive and Active Surveillance, Comparative Observational Studies, Targeted Clinical Investigations and Vaccine Safety Surveillance, Aris G Pharmacovigilance, VigiFlow, Statistical Methods for Evaluating Medication Safety Data
The Pharmacovigilance Programme of India is an Indian government organization which identifies and responds to drug safety problems. Its activities include receiving reports of adverse drug events and taking necessary action to remedy problems.
Geneva Pharma Forum on Pharmacovigilance: Partnering for
Patient Safety (Geneva, 20 November 2012), Jeremiah Mwangi, Director, Policy and External Affairs, IAPO
Pharmacovigilance is the scientific discipline that is concerned with the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems associated with the use of medicinal products.
The primary objective of pharmacovigilance is to ensure the safety and efficacy of medicinal products throughout their life cycle, from preclinical development to post-market surveillance. This involves the systematic collection, analysis, and reporting of adverse drug reactions (ADRs) and other drug-related problems associated with the use of medicinal products.
Key components of pharmacovigilance include:
ADR reporting: Healthcare professionals, patients, and other stakeholders are encouraged to report suspected ADRs to regulatory authorities or pharmaceutical companies. This information is used to detect and assess potential safety signals associated with the use of medicinal products.
Signal detection: The systematic monitoring and analysis of ADR reports, clinical trial data, and other sources of safety data are used to identify potential safety signals associated with the use of medicinal products.
Risk assessment: The assessment of safety signals involves a thorough evaluation of the available safety data to determine the nature and severity of the safety concern, and to identify any potential risk factors that may contribute to the safety concern.
Risk management: Once a safety concern has been identified and assessed, appropriate risk management strategies may be implemented to mitigate the risk or to ensure that the medicinal product is used in a safe and effective manner.
Communication: The dissemination of safety information to healthcare professionals, patients, and other stakeholders is an important component of pharmacovigilance. This information is used to raise awareness about potential safety concerns associated with the use of medicinal products and to promote the safe use of medicinal products.
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.
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
Safalta Digital marketing institute in Noida, provide complete applications that encompass a huge range of virtual advertising and marketing additives, which includes search engine optimization, virtual communication advertising, pay-per-click on marketing, content material advertising, internet analytics, and greater. These university courses are designed for students who possess a comprehensive understanding of virtual marketing strategies and attributes.Safalta Digital Marketing Institute in Noida is a first choice for young individuals or students who are looking to start their careers in the field of digital advertising. The institute gives specialized courses designed and certification.
for beginners, providing thorough training in areas such as SEO, digital communication marketing, and PPC training in Noida. After finishing the program, students receive the certifications recognised by top different universitie, setting a strong foundation for a successful career in digital marketing.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
1. WHO international drug monitoring programme
Anas Saifi
M.Pharm (Pharmacology) 2nd Sem.
School of Pharmaceutical Education And Research
Jamia Hamdard
2. Presentation Outline
• Introduction
• History
• Functions of International Drug Monitoring
• UMC’s role as WHO Collaborating centre
• Role of WHO in pharmacovigilance
• Reporting procedure
• Pharmacovigilance methods
• VigiBase
3. INTRODUCTION
• In 1963, during the 16th world assembly a resolution called for a systemic collection of
information on serious adverse drug reactions during the development and particularly
after medicines have been made available for public use. This led to the formation of
WHO Program for International Drug Monitoring (PIDM).
• Initially the WHO PIDM members consisted of 10 countries.
• Currently, 155 countries are members of the WHO PIDM. Another 21 associate member
countries are in the early stages of establishing their pharmacovigilance systems in
preparation for full membership.
• The ten founder members of the WHO Program in 1968 were Australia, Canada,
Czechoslovakia, Federal Republic of Germany, Ireland, Netherlands, New Zealand,
Sweden, United Kingdom, USA.
• WHO PIDM members submit reports of adverse reactions associated with medicinal
products, known as Individual Case Safety Reports (ICSRs) to the global database
VigiBase.
5. HISTORY
• The establishment of the WHO Program followed the thalidomide disaster of
1961.
• In 1963, during the 16th World Health Assembly, formation of the WHO Program
for International Drug Monitoring.
• In 1971, an international database was established at WHO headquarter in
Geneva.
• In 1978, this database, now known as VigiBase, moved to Uppsala (Pilot project in
USA. Move to Switzerland and then to Sweden).
6. WHO HQ IN GENEVA
• To become an associate member country, the government of a country needs to
send an official application to the WHO HQ in Geneva.
• To become a full member the country also needs to send at least 20 ADR reports
in a correct format.
• WHO Collaborating Centers (+6)
• UMC Sweden
• Morocco
• The Netherlands
• Norway
• India
7. FUNCTIONS OF WHO PIDM
• Functions Of Who PIDM Include-
• Identification and analysis of new adverse reaction.
• Information exchange between WHO and National centers.
• Publication of periodical news letters, guidelines and books in the
Pharmacovigilance and risk management area.
• Supply of tools for management of clinical information including ADR case reports
eg. WHO Drug Dictionary, WHO Adverse Reaction Terminology.
8. FUNCTIONS OF WHO PIDM
• Provision of training and consultancy support to National centers and countries
establishing Pharmacovigilance system.
• Computer software for case report management designed to suit the needs of
National centers.
• Annual meetings for representative of national centers at which scientific and
organizational matters are discussed.
• Methodological research for the development of pharmacovigilance as a science.
10. FUNCTIONS OF WHO HQ
• Exchange of Information- National Information Officers Publications (WHO
Pharm Newsletter, Restricted Pharm List, Drug Alerts, WHO Drug Information).
• Policies, guidelines, normative activities- The Importance of PV (2002) Safety
Reporting - A guide to detecting and reporting adverse drug reactions (2002)
Policy perspectives on medicines (PV) 2004 Safety monitoring of herbal medicines
(2004) PV in Public Health.
• Country support Training courses on PV- Training courses on pharmacovigilance
Address specific / stated needs: antimlalarials…. Annual Meeting of PV Centre.
• Collaborations or partnership
• Resource mobilization- Gates foundation European commission Global Fund
11. WHO COLLABORATING CENTRE THE UPPSALA
MONITORING CENTRE (UMC)
• Established as a foundation 1978.
• Based on agreement Sweden – WHO
• International administrative board
• WHO Headquarters responsible for policy
• Self financing
• Six board members – three appointed by the government and three appointed by
WHO.
• UMC runs the program but WHO is responsible for policy issues.
12. UMC’S ROLE AS A WHO COLLABORATING
CENTRE
• UMC is one of five officially designated collaborating centers.
• UMC is responsible for managing the technical and scientific aspects of the
WHO’s worldwide pharmacovigilance network. It includes:-
1) Analyzing VigiBase data and identifying signals of potential safety problems.
2)Pursue research.
3) Broadening the scope of pharmacovigilance through debate, research and
consultation.
4) To collect, assess and communicate information from member countries
about benefits, harms and risks of drugs to improve patient therapy and public
health worldwide.
5) To collaborate with member countries.
6) Developing and providing data-entry, management, retrieval and analysis
tools such as VigiFlow and VigiLyze.
13. ROLE OF WHO IN PHARMACOVIGILANCE
• To identify ADR that could not be found through clinical trial program.
• Collecting case reports.
• Uppsala Monitoring Centre, Sweden.
• Jobs performed:
1) Signal detection
2) Signal review
3) Education and advisory
4) Research & Development
14. SIGNAL DETECTION PRIMARY UMC TASK
• Identification of previously unknown drug reactions; Our primary goal is to find
signals as early as possible
• (WHO definition)
• Reported information on a possible causal association between an adverse
event and a drug, the relationship being unclear or incompletely documented
previously.
• Information that arises from one or multiple sources (including observations and
experiments), which suggests a new potentially causal association, or a new
aspect of a known association, between an intervention and an event or set of
related events, either adverse or beneficial, that is judged to be of sufficient
likelihood to justify verificatory action.
• The process of signal management in PV is a set of activities, which aim to
determine whether there are new risks associated with a particular drug, or
whether known risks associated with a particular drug have changed.
15. Signal Detection Process
Data mining of ICSRs
Unlisted Drug ADR
combination are Checked
Generation of Hypothesis
Clinical Evaluation
SRP Discussion Information
Regulatory recommendation
16. ADVISORY COMMITTEE ON SAFETY OF
MEDICINAL PRODUCTS (ACSOMP)
• ACSoMP was established in 2003 to provide advice to WHO, including its
Collaborating Centre for International Drug Monitoring (the UMC), and through it
to the Member States of WHO, on safety issues relating to medicinal products.
• It guides WHO on general and specific issues related to Pharmacovigilance (PV).
• The Committee is composed of 12 members drawn from the WHO Expert
Advisory Panels for Drug Evaluation and for Drug Policies and Management and,
where appropriate, in consultation with other relevant WHO clusters and expert
advisory panels.
• ACSoMP meets once a year to discuss ongoing and new PV topics, with particular
focus on issues related to public health programes.
17. VigiBase
• VigiBase is UMC’s starting-point for the journey from data to wisdom about safer
use of medicines and wise therapeutic decisions in clinical practice.
• It is the driving-force at the heart of the work of UMC and the WHO Programe.
• Since 1978 UMC has been responsible for the development and maintenance of
VigiBase.
• The purpose is to ensure that early signs of previously unknown medicines-
related safety problems are identified as rapidly as possible
18. VigiMobile
• VigiMobile, a new app for field reporting of adverse events following
immunization (AEFI), is now available as part of its synchronized IT
solutions for managing AEFIs.
• This has been developed in collaboration with WHO-HQ (PVG, DDI) and the
WHO Collaborating Centre for International Drug Monitoring (UMC).
• VigiMobile follows form for AEFI reporting recommended for collecting
AEFI data and can be used on- or offline in remote areas.
• Using the system, immunization programmes can also share reports with
VigiFlow and VigiBase (the WHO global database of Individual Case Safety
Reports).
• This system will enable decision-makers at district, province, national and
international levels to obtain high-quality AEFI reports, review the vaccine
safety data and respond promptly.
19. REFERENCES
• The WHO Programme for International Drug Monitoring, WHO,
https://www.who.int/teams/regulation-prequalification/regulation-and-
safety/pharmacovigilance/health-professionals-info/pidm visited (28 March 2023)
• WHO, https://www.who.int/teams/regulation-prequalification/regulation-and-
safety/pharmacovigilance visited (28 March 2023)
• Olsson S. (1998). The role of the WHO programme on International Drug Monitoring in
coordinating worldwide drug safety efforts. Drug safety, 19(1), 1–10.
https://doi.org/10.2165/00002018-199819010-00001
• WHO international drug monitoring programme & the Uppsala Monitoring centre ppt,
Shanti Pal and mary Couper, Quality Assurance and Safety Of Medicine, WHO
https://slideplayer.com/slide/5967845/
• WHO international drug monitoring programme ppt.x, Sneha Khandale
https://www.slideshare.net/SnehaKhandale1/who-international-drug-monitoring-
program