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
Requirements And Guidelines For Permission To Import / or Manufacture of New Drugs For Sale or To Undertake Clinical Trials
Schedule Y was introduced under the Drugs and Cosmetics Act 1940, to
introduce requirements for countries to get permission for:
Importing
Manufacturing new drugs
Conducting Clinical Trials.
Application for permission
Clinical Trial
Studies in specific population
Post marketing surveillance
Special studies: BA/BE studies
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
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.
Vaccine:It’s Uses and Advantages & Disadvantages.HaladharHembram2
Therapeutics and Heath Management In Aquaculture: AQC:507
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms the microbe. The agent stimulates the body’s immune system to recognize the agent as foreign, destroy it, and “remember” it, so that the immune system can more easily recognize and destroy any of these microorganisms that it later encounters in future.
Aquaculture continues to expand, disease problems will increase. Therefore, disease research and the implementation of new disease control concepts are important to maintain sustainability.
The development of an effective vaccine is a complex process. One of the prerequisites understanding of basic epidemiology of diseases and the immune system of the target species is required.
The importance of disease control is increasingly recognized by both farmers and governments due to the significant economic losses caused by diseases and international pressure on the use of chemicals and antibiotics.
A number of vaccines have been in used by the salmonid industry for decades, however, commercial vaccine development for other aquaculture sectors, including warm water fish, is still quite limited.
Requirements And Guidelines For Permission To Import / or Manufacture of New Drugs For Sale or To Undertake Clinical Trials
Schedule Y was introduced under the Drugs and Cosmetics Act 1940, to
introduce requirements for countries to get permission for:
Importing
Manufacturing new drugs
Conducting Clinical Trials.
Application for permission
Clinical Trial
Studies in specific population
Post marketing surveillance
Special studies: BA/BE studies
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
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.
Vaccine:It’s Uses and Advantages & Disadvantages.HaladharHembram2
Therapeutics and Heath Management In Aquaculture: AQC:507
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms the microbe. The agent stimulates the body’s immune system to recognize the agent as foreign, destroy it, and “remember” it, so that the immune system can more easily recognize and destroy any of these microorganisms that it later encounters in future.
Aquaculture continues to expand, disease problems will increase. Therefore, disease research and the implementation of new disease control concepts are important to maintain sustainability.
The development of an effective vaccine is a complex process. One of the prerequisites understanding of basic epidemiology of diseases and the immune system of the target species is required.
The importance of disease control is increasingly recognized by both farmers and governments due to the significant economic losses caused by diseases and international pressure on the use of chemicals and antibiotics.
A number of vaccines have been in used by the salmonid industry for decades, however, commercial vaccine development for other aquaculture sectors, including warm water fish, is still quite limited.
A brief presentation on fish vaccination and its application particularly in Bangladesh. The overall process is described in a nutshell here. The types, procedure of formation, regulation, licensing and use are among them.
Inoculation with a specific biological substance (antigen) to stimulate resistance or immunity to a particular disease.
Purpose of vaccination
To prevent or reduce problems that can occur from infection of a field strain of a disease organism
To incite high levels of immunity to protect birds in the face of aggressive endemic disease challenges.
To prevent heavy losses in the form of high mortality, morbidity and lowered protective performance by building up resistance in birds
To hyper immunize hens to maximize maternally derived antibody passed through the egg to the hatching progeny.
Dossier Vaccination: what causes poultry vaccination to failHarm Kiezebrink
This is the third presentation on vaccination, posted recently by Dr. Ossama Motawae, an Egyptian veterinarian. In this presentation, he explains what causes vaccination programs to fail. An interesting presentation for those who are not so familiar with the day-to-day practice of poultry vaccination.
fish ecology and feed chain in aquatic enviromentwaleedelhawarry2
describe the aquatic ecosystem and different natural food and feeding habits of fish species, thus helping to quite clearly understand the requirements for successful fish farming
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
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.
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.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
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
Francesca Gottschalk - How can education support child empowerment.pptxEduSkills OECD
Francesca Gottschalk from the OECD’s Centre for Educational Research and Innovation presents at the Ask an Expert Webinar: How can education support child empowerment?
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.
Embracing GenAI - A Strategic ImperativePeter 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.
3. What is the vaccine ?
•
Is a biological preparation
(virl,bacterial,protozoan)which introduced to
the bird to improve its immunity to a
particular disease.
4. What is the vaccination ?
•
Administration of a biological preparation
(virl,bacterial,protozoan) to stimulate the
immunity system to produce specific anti body
levels against a particular disease by specific
methods according to the manufacturer
instructions.
5. What is the immunization ?
•
After vaccination ,the immune system of the
bird and its immune cells provoke the immune
response and present the anti gen to T
lymphocyte and by macrophage and from
there it is expressed to B lymphocyte where
response is initiated in term of anti body.
6. Why we vaccinate the poultry
flocks ?
•
to protect poultry flocks against field disease
organisms .
•
due to increase in no. of people all over the
world and there for their needs form meat
and eggs production increase so we need to
produce healthy protected flocks to produce
the people needs and to avoid money losses
by billions in case of infection occurs.
7. Types of poultry vaccines.
1-Live attenuated vaccines
through serial passage of alive pathogen as a
virus into S.P.F embryonated chicken egg or
tissue cultures
stimulating both cell and antibody mediated
immunity response.
2-killed inactivated vaccines
occurs by heat or chemical treatment and after
vaccination
stimulate only antibody mediated immunity
response
8. •
3-DNA vaccines
•
the DNA encoding an antigen of a pathogen
is
•
inserted to vector plasmid
•
elicit both cell and antibody mediated
immunity response.
•
4-Recombinant vaccines
•
Encoding proteins of specific viruses on pox
virus or marek's virus as vectors
•
elicit both cell and antibody mediated
immunity response.
9. How to apply the vaccine?
•
1-in ovo vaccination
•
applied in the hatchery by the Inovoject
system requires two well- trained persons at
18-day-old embryonated eggs,
•
reduce labor costs, stress of handling and
injection, earlier development of immunity
,for a live vaccines.
10. •
2-Drinking water vaccination
• applied in water which not contain sanitizer or add
the vaccine stabilizer(colored)
•
enough drinker, enough thirst time that allow the
bird consume the vaccinated water maximum in
two hours,
•
use of the vaccine as soon as possible after
reconstitution,
for a live vaccines.
11. •
3-spray method vaccination
•
apply of a live vaccine by spraying using cabinet
sprayers in the hatchery or we spraying the bird
in the farm.
•
should close the ventilation system before and
after applying of the live vaccine for short time to
adjust RH and make that the vaccine comes on
the bird, also decrease the light intensity or spray
at the night, the adjustment of the size of the
droplet according the age of the flock, take care
of the respiratory problems before spraying to
avoid the post vaccinal reaction, use of treated
water free from sanitizer or minerals.
13. •
4-Eye drop vaccine:
•
apply of a live vaccine into the eye ,costs labor,
time more accurate
5-Wing web vaccination: in case of pox vaccines
which reconstituted in special diluent and applied
by special forks with double needles.
15. What are our research Items ?
•
1- When the vaccination failure occurs?
•
2-Causes of vaccination failure .
•
3-Notes on mange mental causes of vaccination
failure.
•
And finely........
•
The research goal Is
•
How to overcome the causes of vaccination
failure.
16. 1-When vaccination failure
occurs?
•
A vaccination failure occurs when, following
vaccine administration, the chicken do not
develop adequate anti body titer level and /or
are susceptible to afield disease outbreak and
the tendency to blame the vaccine although
there are other factors must be evaluated to
determine the cause of vaccination failure.
17. 2-Causes of vaccination failure.
•
A--Causes related to the vaccine itself:
•
1-use of an expired vaccines which leads to no immunity
response.
•
2-use of a vaccine of poor antigenicity which means that
the live vaccine must be applied at the level or above the
minimum infective dose and also inactivated vaccines
should contain sufficient amount of antigen to stimulate an
immune response when applied to the bird
•
3-use of vaccine strain/serotype different from field strain
which leads to no protection against field strain
•
4-use of a vaccine that has been excessively attenuated
which leads to a lack of immunogenicity and enhances the
susceptibility to field challenge.
18. •
B—Mange mental causes of vaccination failure.
•
1- the vaccination program :use of one stable
vaccination program to the farm without any
considerations to the field strains challenge .
•
2- Improper storage and transportation of vaccine :
•
Most common
•
improper transportation from manufacture to
distributer to market or from market to farm.
•
Failure of electricity ,failure of refrigerator ,storage
in deep freezer ,exposure to sunlight ,ignoring use of
ice box ,coolers, using of translucent thin membrane
shopper permitting the sunlight exposure , and
exposure to viricidal disinfectant(phenol-alcohol)
this inactivate the vaccine
19. •
3-Improper handling of the vaccine:
•
: improper handling prior administration leads
to vaccine damage
•
4-Improper administration of the vaccine
•
: via inappropriate route/site
•
for example pox vaccine has mistakenly been
confused with I.L.T vaccine gives by eye drop
route which resulted in pox lesions in eye with
•
substantial losses.
20.
21. •
5-The effect of passive immunity(maternal
immunity)
•
If the breeder flock has high levels of circulating
antibodies which pass to the progeny through
egg this may interfere with replication of live
vaccine viruses
•
6-Environmental stress factor:
•
such as extreme heat produce high level of
steroid which decrease lymphocyte so antibody
not produced
22.
23. •
7-Health status of the flock:
•
: timing of vaccination
•
, avoid vaccination of sick flock because of their
immunity system is already functioning at
diminished capacity.
•
8-Immuno-suppressive conditions:
•
: such as infection with IBD-CIV-Marek's disease ,
mycotoxicosis means that both cellular and non-
cellular immunity not functioning properly result in
development of limited protection and excessive
vaccine reaction including morbidity and mortility.
24. •
9-Genetic resistance:
•
the major histocompatibity complex (MHC) varies
from bird to bird and its structure dictate if a bird
will respond to an antigen at all, due to some
structural lack in MHC it is possibility that birds
recognize one of antigen therefore that strain of
birds might be more susceptible to pathogen
•
10-excessive use of drugs:
•
lead to immune-suppressive bird causing poor
immunity development.
25. •
11-Interference:
•
interference between two vaccines cause
vaccination failure, for example live respiratory
vaccines (IB,ND,ILT)should not be given within 3-4
days if not combined by the manufacturer in
licensed combination ,reaction may be too great or
response to latter vaccine may compromised due to
interference.
26. 4-How to overcome vaccination
failure.
•
1-Biosecurity: means making of some preventive
measures to prevent the introduce the disease into the
farm by,
•
a-between 2 cycles;
•
•
1—proper cleaning and disinfection
•
2—water quality,water sanitation
•
3—insect control
•
4—rodent control.
•
5—feed sanitation(treatment)
27. •
b-when the flock in;
•
•
1—provide proper and good mange mental factor;
•
/provide suitable temperature.
•
/provide suitable relative humidity.
•
/provide suitable stocking density.
•
/provide good balanced ration.
•
/provide vitamins and mineral therapy
•
/decrease uses of drugs.
•
/provide suitable ventilation system.
28. •
c—vaccination;
•
/make suitable vaccination program according to diseases challenge in farm area
•
/follow the all instruction of manufacturer's in storage, transportation , handling , and
administration.
•
/use of well-trained persons.
•
/make vaccination records to each cycle to discover any failure.
•
d—control measures during the cycle
•
/strict control at the gates of the farm
•
/strict control on the vehicles
•
/strict control on visitors
•
/strict control on pets ,wild birds and rodents.
•
/put disinfectant in front gates, every poultry house.
•
/proper disposal of dead birds.
•
•