This gives you a basic role pharmacovigilance and how it works before and after drug approval .It totally work for human needs.And what are governing bodies for pharmacovigilance and how to write Adverse Drug Reaction (ADR) Reporting Procedure.
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 aim of Safety reports is describe the safety during the lifecycle of the medicinal product. These reports are necessary during development as well as during the authorization process or renewal. In addition, several of these reports may be required by Health Authorities in case of safety concerns.
This presentation contains a full overview about periodic safety update reports and all the information related with it.
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 aim of Safety reports is describe the safety during the lifecycle of the medicinal product. These reports are necessary during development as well as during the authorization process or renewal. In addition, several of these reports may be required by Health Authorities in case of safety concerns.
This presentation contains a full overview about periodic safety update reports and all the information related with it.
Pharmacovigilance is a scientific discipline concerned with the collection, detection, assessment, monitoring, and prevention of adverse effects of pharmaceutical products.
Pharmacovigilance is a branch of Pharmacoepidemiology and is restricted to the study of adverse effects of drugs.
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Pharmacovigilance planning refers to the systematic and proactive approach taken by pharmaceutical companies, regulatory agencies, and other stakeholders to establish strategies and procedures for monitoring the safety of drugs throughout their lifecycle. It involves creating a comprehensive framework to detect, assess, understand, and prevent adverse effects or any other drug-related problems. Here are some key aspects to consider in pharmacovigilance planning
If you are marketing your product in India you should comply these area of regulation.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Setting up of new pharmacovigilance centresPriti Gupta
this is just an overview of the setting up of pharamcovigilance with fake name of company and product. budget is also an imagination. there is not exact representation of the actual situation.
Pharmacovigilance is a scientific discipline concerned with the collection, detection, assessment, monitoring, and prevention of adverse effects of pharmaceutical products.
Pharmacovigilance is a branch of Pharmacoepidemiology and is restricted to the study of adverse effects of drugs.
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
Pharmacovigilance planning refers to the systematic and proactive approach taken by pharmaceutical companies, regulatory agencies, and other stakeholders to establish strategies and procedures for monitoring the safety of drugs throughout their lifecycle. It involves creating a comprehensive framework to detect, assess, understand, and prevent adverse effects or any other drug-related problems. Here are some key aspects to consider in pharmacovigilance planning
If you are marketing your product in India you should comply these area of regulation.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Setting up of new pharmacovigilance centresPriti Gupta
this is just an overview of the setting up of pharamcovigilance with fake name of company and product. budget is also an imagination. there is not exact representation of the actual situation.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problem.
All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use.
The clinical trial process involves studying these products in a relatively small number of selected individuals for a short period of time.
Certain side effects may only emerge once these products have been used by a heterogenous population, including people with other concurrent diseases, and over a long period.
PHARMACOVIGILANCE - A Worldwide masterkey for Drug MonitoringVenugopal N
Pharmacovigilance is the pharmacological science that aims at the detection, assessment, monitoring, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines to ensure drug safety.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
pharmacovigilance from pharmaceutical administration topic presented by konatham kumar reddy from chilkur balaaji college of pharmacy hyderabad telangana
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The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
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Acetabularia Information For Class 9 .docxvaibhavrinwa19
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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.
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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.
3. •Pharmacovigilance(PV) is the pharmacological
science relating to the detection, evaluation,
understanding and prevention of adverse drug
reactions or any other drug-related problems .
•As such, pharmacovigilance heavily focuses
on adverse drug reactions, or ADRs.
PHARMACOVIGILANCE
4. •To role pharmacovigilance they receiving
information data from patients and health care
providers via pharmacovigilance agreements
(PVAs), as well as other sources such as the medical
literature.
•Ultimately, pharmacovigilance is concerned with
identifying the hazards associated with
pharmaceutical products and with minimizing the
risk of any harm that may come to patients.
PHARMACOVIGILANCE
5. Pharmacovigilance
Major Aims
• early detection of unknown safety problems
• identification of risk factors
• quantifying risks
• preventing patients from being affected
unnecessarily
Rational and Safe use of Medicines
5
8. Why Pharmacovigilance?
Post Marketing Topics
• Unexpected adverse reactions
• Interactions
• Risk factors
• Quality of life
• Long-term efficacy
• Cost assessment
8
9. Why Pharmacovigilance?
10% of people of the some countries is admitted
in hospital due to ADR events .
Adverse Drug Reactions are among the top ten
causes of mortality.
9
11. GOVERNING BODIES
•The pharmaceutical industry.
•Regulatory authorities.
•WHO collaborating centre for international drug
monitoring.
•CIOMS(Council for International Organisation of
Medical Science).
12. WHO Programme for International Drug
Monitoring
12
WHO
HQ
WHO
Collaborating
Centre, Uppsala
National
Centres
•Policy.
•Exchange of Information.
•Technical support to
countries .
•Advisory Committee on
Safety of Medicinal Products.
ADR Reports
•Analysis
•Output
Feedback to National
Centres.
Signal documents.
13. Adverse event
•Any adverse change in health or side effect that occurs
while the patient is receiving the treatment.
Serious adverse event(SAE)
It is defined as any adverse event occurrence that at any
dose results.
•In death
•Is life threatening
•Requries inpatient hospitalization
•Birth defect
•Permanent damage
14. ADVERSE DRUG REACTION (ADR)
•An adverse drug reaction (ADR) is an injury caused
by taking a medication. ADRs may occur following a
single dose or prolonged administration of a drug or
result from the combination of two or more drugs.
•The study of ADRs is the concern of the field known
as pharmacovigilance.
15. ADVERSE DRUG REACTION (ADR)
REPORTING PROCEDURES
•Every country with a
developed pharmacovigilance
system has its own form.
National reporting Form
16. Yellow card scheme
•The Yellow Card Scheme is the UK system for
collecting information on suspected adverse
drug reactions (ADRs) to medicines.
•ADRs can be reported by anyone; this is usually
done by healthcare professionals – including
doctors, pharmacists and nurses – but patients
and carers can also make reports.
17. Yellow card scheme
It contains patient details , suspected drug and suspected reaction
18. Periodic safety update Report(PSURs)
Periodic Safety Update Reports (PSURs) is a
pharmacovigilance document intended to provide an
evaluation of the risk-benefit balance of a medicinal
product at defined time points post- authorization.
First 2 years: every 6 months.
Next 2 years: every year.
After that every 3 years.
But this (PSURs) now changes to PBRER (periodic
benefit risk evaluation report, on 21st Jul in 2012).
19. Pharmacovigilance program of
india (PVPI)
•Officially started on 23 November 2004 at new
Delhi.
PVPI is under control of-
1. CDSCO(Centarl Drugs Standard Control
Organization).
2. Directorate general of health services.
3. Indian pharmacopeia commission (Ghaziabad).
4. The programme is conducting by NCC(National
Coordinatinating Center)
20. Objectives :-
•To monitor the ADRs.
•To create awareness among health care
professionals about ADRs.
•To monitor benefits-rifts of the drug.
•Supports CDSCO.
•Communicate findings with all stake holders.
•Create a national centre.
21. PVPI will be administered and monitored by
the following committees.
1. Steering committee.
2. Strategic advisory committee.
Technical support by-
1. Signal review panel
2. Core training panel
3. Quality review panel
