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
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
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
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.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
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.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
Các quy định về hậu lưu hành thuốc ở Nhật Bản sử dụng dữ liệu thế giới thực để đánh giá và kiểm soát. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU
SVMPharma Real World Evidence – Real World Evidence & Adaptive PathwaysSVMPharma Limited
SVMPharma Real World Evidence (RWE) – In this paper, we are talking about Adaptive Pathways (AP), an ambitious and evolving new initiative by the European Medicines Agency (EMA) which incorporates Real World Evidence into regulatory approvals and market authorisation.
For more resources on RWE visit us at www.svmpharma.com
Challenges and Opportunities Around Integration of Clinical Trials DataCitiusTech
Conducting a Clinical Trial is a complex process, consisting of activities such as protocol preparation, site selection, approval of various authorities, meticulous collection and management of data, analysis and reporting of the data collected
Each activity is benefited from the development of point applications which ease the process of data collection, reporting and decision making. The recent advancements in mobile technologies and connectivity has enabled the generation and exchange of a lot more data than previously anticipated. However, the lack of interoperability and proper planning to leverage this data, still acts as a roadblock in allowing organizations truly harness their data assets. This document will help life sciences IT professionals and decision makers understand challenges and opportunities around clinical data integration
Introduction to Regulatory Affairs - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, June 14, our colleagues Fiorenzo Savoretti, Senior Regulatory and Quality Consultant at Pfizer and Nick Deschacht, Senior RA Consultant at GSK, gave an interesting “Introduction to Regulatory Affairs”.
Fiorenzo and Nick talked about RA and their projects, each from their unique angle. They delivered their presentations for ## attendees at our Brussels office at the Lambroekstraat 5a in Diegem.
Greetings from Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “5th Pharmacovigilance Congregation 2013” The conference will be held on 20th November 2013, Kohinoor Continental Hotel, Mumbai, India.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
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Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
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1. Presented By
Nipun Gupta 810501
Ankush 810512
Naveen 810499
Sudhir 810486
Sumit 810509
B. Pharmacy 8th Semester
2017-2021
Under the Supervision of
Mrs. Roopal Mittal
Assistant Professor (Pharmacology)
R.K.S.D. College of Pharmacy, Kaithal (Haryana)
2. Pharmacovigilance
Pathway of PvPI
Establishment of PV Programme in Hospital
Data Acquisition
Constitution and Functioning
Role of PV in Hospital
Establishment of PV Programme in Industry
Aim
Scientific Character
Pre marketing Surveillance
Post Marketing Surveillance
Contract Research Organization
Identification and Selection
Function of CRO
Establishment a National Programme
Organization
Function
Communication Process and flow of ADR
Contents
3. Pharmacovigilance Science and activities relating to the
Detection
Assessment
Understanding
Prevention
of adverse drug reaction or any other possible drug related problems
4. HISTORY AND DEVELOPMENT
1986 Initiation of PvPI by Name of ADRs Monitoring System
(12 regional center) under supervision of DCGI
1998 India Join WHO PIDM
2005 National Programme for PV launch
2010 PvPI come in force with NCC, AIIMS as well as 22 AMC
2011 NCC, AIIMS transferred to IPC, Ghaziabad
2017 250+ ADR monitoring center
7. Patient
ADE Monitoring
Suspected Medicines
Other Medicines
Risk Factors
Reporter
Data Acquisition/CRF
Reports of Suspected ADRs are taken in case report form CRF which include
minimum following Information
9. Role of PV in Hospital
Role of
PV in
Hospitals
Informatio
n Service
Reachi
ng out
Appraisal
Secondar
y
preventio
n of ADRs
Data
Processi
ng
Hypothesizi
ng
Medicine
Regulatio
n
10. Improve patient care and safety in relation to use of medicine
Protect patient from unnecessary harm by previously unrecognized drug
hazards
Elucidating pre disposing factors
Refuting false safety signal
To quantifying risk in relation to benefit
Aim
13. Post Marketing Surveillance
Spontaneous Reporting
Unsolicited communication by healthcare professionals or consumers to a
company, regulatory authority or other organisation (e.g., WHO, CDSCO etc.)
that describes one or more adverse drug reactions in a patient who was given
one or more medicinal products
Targeted Spontaneous Reporting
To learn more about the ADR profile of specific medicine(s) in your
population Or To estimate the incidence of a known ADR to a specific
medicine in your population
Cohort Study
Cohort study of adverse events associated with one or more monitored medicines.
It is related to class of medicine that has previously caused ADRs Potentially
significant adverse event observed during post-marketing surveillance
Like Retrospective, Prospective
14. Ensure patient safety and
product efficacy
Part of the solution in healthcare delivery
Embrace rnulli0lJannel strategy and digital systems
Drive patient-centric approaches
A new plan for effective Implementation of Pharmacovigilance in the Industry
Future Goal
15. CONTRACT RESEARCH ORGANISATION
A CRO is an organisation contracted by another company to manage and lead the
company's trials, duties and functions.
CRO Identification and Selection
Preparing study designs for each of the research studies to be outsourced.
Determining which CROs should be considered as potential contractors.
Soliciting cost and time proposals which include determining if the CROs understands
the study design and selecting those CRO to be consider further.
Scheduling and conducting site visits to ensure the CROs are qualified.
Negotiating time and cost for completion of research studies.
Selecting the CROs and awarding the contracts for each study to be outsourced.
16. Function of CRO
CRO
Project
Initiation
Concept and
feasibility
Product
Development and
Pre Clinical Testing
Prototyping,
Development,
Validation,
Bench test etc.
Clinical Trial
Protocol
Development,
Initiation &
Monitoring,
Investigation,
Data analysis,
Reporting
Regulatory
Submission
Post-
Marketing
Surveillance
Monitoring
17. Indian
Pharmacopoeia
Commission
NCC PvPI
CDSCO
Headquarter
New Delhi
AEFI and
ITSU
MoHFW
NIB
MoHFW
Noida
Uppsala
Monitoring
Centre,
Sweden
Adverse
Drug
Monitoring
Centre
WHO India
(Country
Office)
National
Health
Programme
MoHFW
Govt. of
India
Establishment of National Pharmacovigilance
Programme
Organization