Introduction to ICSR Narrative Writing 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
Introduction to ICSR Narrative Writing 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
breif notes on what is pharmacoepidemiology, why do we need pharmacoepidemiology, whats is its aim and its main applications, advantages and disadvantages
This Presentation contains an introduction to clinical research.
* Basic definition of Clinical Research.
* Steps involved in clinical Research.
* Phases in Clinical Research.
* Types of clinical Trials.
Pharmacovigilance - Defination, Aim, Need ,Importance ,history, workflow, co...MADHAV JAJNURE
pharmacovigilance(PV)
Defination of pharmacovigilance
Aims of pharmacovigilance
Origin of pharmacovigilance
History of pharmacovigilance
Importance of pharmacovigilance
Work flow of Pharmacovigilance
Conclusion
breif notes on what is pharmacoepidemiology, why do we need pharmacoepidemiology, whats is its aim and its main applications, advantages and disadvantages
This Presentation contains an introduction to clinical research.
* Basic definition of Clinical Research.
* Steps involved in clinical Research.
* Phases in Clinical Research.
* Types of clinical Trials.
Pharmacovigilance - Defination, Aim, Need ,Importance ,history, workflow, co...MADHAV JAJNURE
pharmacovigilance(PV)
Defination of pharmacovigilance
Aims of pharmacovigilance
Origin of pharmacovigilance
History of pharmacovigilance
Importance of pharmacovigilance
Work flow of Pharmacovigilance
Conclusion
The safe use of medicines is perhaps the single most important criteria that any regulatory authority within a given country has to ensure in order both to protect the public health and the integrity of its health care system. For the same purpose pharmacovigilance was established. According to WHO, Pharmacovigilance is the science and activities related to the collection, detection, and assessment of ADR’s. It promotes the systematic, rational use and assures the confidence for the safety of drugs. It improves patient care and safety. Significance of pharmacovigilance is growing as the patients or consumers have become more responsive about the advantage and hazard of medicines. Pharmacovigilance is a complex process and a robust system is essential to undertake the activity. A good pharmacovigilance system will identify the hazard aspects in the short period of time. This review article tries to explain the some basic principles, history and developments, methods and some scope of this developing field i.e. Pharmacovigilance in India.
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
The Role of Pharmacovigilance in Ensuring Drug Safety and EfficacyClinosolIndia
Pharmacovigilance plays a vital role in ensuring drug safety and efficacy throughout the entire lifecycle of a pharmaceutical product. Here are the key aspects of pharmacovigilance in safeguarding public health:
Early Detection of Adverse Drug Reactions (ADRs): Pharmacovigilance systems collect and analyze data on ADRs reported by healthcare professionals and patients. This enables the early detection of potential safety concerns associated with drugs, including known and previously unrecognized adverse effects.
Signal Detection and Evaluation: Pharmacovigilance activities involve the systematic identification and evaluation of safety signals, which are indications of potential risks associated with a drug. Signals are assessed by analyzing data from various sources, such as spontaneous reports, clinical trials, literature, and real-world evidence, to determine their clinical significance and inform regulatory action if necessary.
Risk Assessment and Benefit-Risk Evaluation: Pharmacovigilance assesses the balance between the benefits and risks of drugs. The collected data are evaluated to determine whether the benefits of a drug outweigh its risks or if any additional safety measures are required. This information guides regulatory decisions, such as labeling changes, restrictions, or even withdrawal of the drug from the market.
Post-Marketing Surveillance: Pharmacovigilance is crucial in monitoring the safety of drugs after they have been approved and marketed. It involves ongoing surveillance and analysis of real-world data, including ADR reports, electronic health records, and other sources, to identify new or rare adverse effects that may emerge in larger patient populations or specific subgroups.
Pharmacovigilance is defined as, The pharmacological science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines or Pharmacovigilance is the name given to the mechanisms and controls that together map and ensure the safety of a medicine throughout its life span – from test tube to patient.
pharmacovigilance from pharmaceutical administration topic presented by konatham kumar reddy from chilkur balaaji college of pharmacy hyderabad telangana
Patient-centered pharmacovigilance represents a pivotal shift in the landscape of healthcare, emphasizing the active involvement of patients in the monitoring and reporting of adverse drug reactions. Unlike traditional pharmacovigilance, which primarily relies on healthcare professionals to identify and document adverse events, this approach recognizes patients as critical stakeholders in ensuring medication safety. By empowering patients to share their experiences, concerns, and observations regarding medication effects, whether positive or negative, healthcare systems can gain a comprehensive understanding of drug safety and efficacy in real-world settings. Patient-centered pharmacovigilance fosters a collaborative partnership between patients, healthcare providers, and regulatory agencies, promoting transparency, accountability, and ultimately, better patient outcomes. Through increased patient engagement and the utilization of patient-reported data, this approach enables healthcare systems to identify potential safety issues earlier, tailor treatment strategies to individual needs, and enhance overall drug safety surveillance efforts.
Struggling with intense fears that disrupt your life? At Renew Life Hypnosis, we offer specialized hypnosis to overcome fear. Phobias are exaggerated fears, often stemming from past traumas or learned behaviors. Hypnotherapy addresses these deep-seated fears by accessing the subconscious mind, helping you change your reactions to phobic triggers. Our expert therapists guide you into a state of deep relaxation, allowing you to transform your responses and reduce anxiety. Experience increased confidence and freedom from phobias with our personalized approach. Ready to live a fear-free life? Visit us at Renew Life Hypnosis..
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
QA Paediatric dentistry department, Hospital Melaka 2020Azreen Aj
QA study - To improve the 6th monthly recall rate post-comprehensive dental treatment under general anaesthesia in paediatric dentistry department, Hospital Melaka
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
R3 Stem Cells and Kidney Repair: A New Horizon in Nephrology" explores groundbreaking advancements in the use of R3 stem cells for kidney disease treatment. This insightful piece delves into the potential of these cells to regenerate damaged kidney tissue, offering new hope for patients and reshaping the future of nephrology.
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptx
Outlining pharmacovigilance
1. Define Pharmacovigilance. Explain the meaning of ADR, AE, and SAEs. On the basis of your own
internet research explain why pharmacovigilance is important in drug discovery and healthcare
1
Define Pharmacovigilance. Explain the meaning
of ADR, AE, and SAEs. On the basis of your own
internet research explain why pharmacovigilance
is important in drug discovery and healthcare
Fernanda Ferreira, f.lima22
Student of Advanced Post Graduate Diploma in Pharmacovigilance & Medical Writing,
James Lind Institute, Jul-2016
The objective of this paper is to outline pharmacovigilance (and related terms) and why it is
important in drug discovery and healthcare
Background
The World Health Organization (WHO)
defines Pharmacovigilance as the science and
activities relating to the detection, assessment,
understanding and prevention of adverse
effects or any other drug-related problem1
.
Recently, its concerns have been widened to
include:
• herbals
• traditional and complementary
medicines
• blood products
• biologicals
• medical devices
• vaccines 2
.
Over the past 50 years, pharmacovigilance has
evolved as an international initiative as well as
a scientific practice. The international
recognition of the pressing need for worldwide
collaboration on medicines safety monitoring
came about largely as a result of the
thalidomide tragedy in the early 1960s, in
which many thousands of congenitally
deformed infants were born as the result of in
uterus exposure to a medicine.7 Following this
tragedy, the Sixteenth World Health Assembly
in 1963 adopted a resolution (WHA 16.36)
that reaffirmed the need for early action with
regard to the rapid dissemination of
information on Adverse Drug Reaction
(ADR). This resolution led to the creation of
the WHO Pilot Research Project for
International Drug Monitoring in 1968, which
purpose was to develop an internationally-
applicable system for detecting previously
unknown or poorly understood adverse effects
of medicines. The initiative currently has 118
official member states, and 29 associate
member states 3
.
From these beginnings emerged the practice
and science of pharmacovigilance. Systems
were developed in Member States for the
collection of individual case histories of ADRs
and evaluation of them. The collection of
international ADR reports in a central
database, would serve the important function
of contributing to the work of national drug
regulatory authorities, improve the safety
profile of medicines, and help avoid further
disasters2
.
Important pharmacovigilance terms
• Adverse Event (AE)
Any untoward medical occurrence in a patient
or clinical investigation subject administered a
pharmaceutical product and which does not
necessarily have to have a causal relationship
with this treatment. An AE can therefore be
any unfavourable and unintended sign
(including an abnormal laboratory finding, for
example), symptom, or disease temporally
associated with the use of a medicinal product,
whether or not considered related to the
medicinal product4
.
2. Define Pharmacovigilance. Explain the meaning of ADR, AE, and SAEs. On the basis of your own
internet research explain why pharmacovigilance is important in drug discovery and healthcare
2
• Adverse Drug Reaction (ADR)
A response which is noxious and unintended,
and which occurs at doses normally used in
humans for the prophylaxis, diagnosis, or
therapy of disease, or for the modification of
physiological function. (WHO, 1972). An
adverse drug reaction, contrary to an adverse
event, is characterized by the suspicion of a
causal relationship between the drug and the
occurrence, i.e. judged as being at least
possibly related to treatment by the reporting
or a reviewing health professional. In the
European Union (EU) Directive 2010/84,
which became applicable in July 2012 an
adverse reaction is defined as: A response to a
medicinal product which is noxious and
unintended5
.
• Serious adverse event (SAE)
An adverse event or suspected adverse
reaction is considered "serious" if, in the view
of either the investigator or sponsor, it results
in any of the following outcomes: Death, a
life-threatening adverse event, inpatient
hospitalization or prolongation of existing
hospitalization, a persistent or significant
incapacity or substantial disruption of the
ability to conduct normal life functions, or a
congenital anomaly/birth defect. Important
medical events that may not result in death, be
life-threatening, or require hospitalization may
be considered serious when, based upon
appropriate medical judgment, they may
jeopardize the patient or subject and may
require medical or surgical intervention to
prevent one of the outcomes listed in this
definition. Examples of such medical events
include allergic bronchospasm requiring
intensive treatment in an emergency room or at
home, blood dyscrasias or convulsions that do
not result in inpatient hospitalization, or the
development of drug dependency or drug
abuse6
.
The importance and objectives of
pharmacovigilance
Conceptually, pharmacovigilance is most
commonly thought of in terms of post-
marketing surveillance through ADRs
reporting and through so-called phase IV
clinical trials, however, pharmacovigilance is
actually an integral part of a biopharmaceutical
product’s entire life cycle, from clinical
development to the introduction of follow-on
generic products2
.
Therefore, pharmacovigilance is a much wider
practice than simply monitoring ADRs. In fact,
pharmacovigilance encompasses all the
aspects within a biopharmaceutical product or
technology’s life-cycle which concerns its
safety and quality. As such, an effective
pharmacovigilance system necessitates the
active involvement of regulatory authorities,
manufacturers and distributors, healthcare
institutions and professionals, as well as
patients3
.
The specific aims of pharmacovigilance are to:
• improve patient care and safety in relation to
the use of medicines and all medical and
paramedical interventions,
• improve public health and safety in relation
to the use of medicines,
• contribute to the assessment of benefit, harm,
effectiveness and risk of medicines,
encouraging their safe, rational and more
effective (including cost-effective) use, and
• promote understanding, education and
clinical training in pharmacovigilance and its
effective communication to the public2
.
In countries and regions such as the US, EU,
Japan, Canada and Australia,
pharmacovigilance is not a new concept but an
established and essential part of the drug
regulatory framework. However, even for the
most advanced drug regulatory authorities,
new gaps and challenges are constantly
emerging which necessitate closer attention, as
these gaps potentially pose patient safety and
public health concerns3
.
References
1. Pharmacovigilance. World Health
Organization website.
http://www.who.int/medicines/areas/qualit
y_safety/safety_efficacy/pharmvigi/en/.
Accessed on 07/28/16.
3. Define Pharmacovigilance. Explain the meaning of ADR, AE, and SAEs. On the basis of your own
internet research explain why pharmacovigilance is important in drug discovery and healthcare
3
2. The Importance of Pharmacovigilance -
Safety Monitoring of medicinal products.
Essential Medicines and Health Products
Information Portal - World Health
Organization.
apps.who.int/medicinedocs/pdf/s4893e/s48
93e.pdf. Accessed on 07/28/16.
3. Pugatch M, Torstensson D, Laufer M. The
Evolution of Pharmacovigilance -
Labeling, Packaging and Pharmacopeia
Standards. 2015; http://www.pugatch-
consilium.com/reports/The%20Evolution%
20of%20Pharmacovigilance.pdf.
Accessed on 07/28/16.
4. ICH Topic E2A Clinical Safety Data
Management: Definitions and Standards
for Expedited Reporting. European
Medicines Agency website.
http://www.ema.europa.eu/docs/en_GB/do
cument_library/Scientific_guideline/2009/
09/WC500002749.pdf. Accessed on
07/28/16.
5. Glossary of terms used in
Pharmacovigilance. World Health
Organization website. www.who-
umc.org/graphics/25301.pdf. Accessed on
07/28/16.
6. CFR - Code of Federal Regulations Title
21 - Sec. 312.32 IND safety reporting. US
FDA website.
http://www.accessdata.fda.gov/scripts/cdrh
/cfdocs/cfcfr/CFRSearch.cfm?fr=312.32.
Accessed on 07/22/16.