This presentation explores the origin of good Clinical Practice, Need of GCP. Principals of Good Clinical Practices. Its a ICH guideline E6.This presentation is very useful to prepare for interviews in the field of Clinical Research.
Elite Institute of Pharma Skills gives quality Education to Pharmacy and Life Science graduates in the field of Regulatory Affairs, Clinical Research, Pharmacovigilance and Medical Coding.
for more details log on to
www.elite-pharmaskills.com
7028042239
Describes in detail definition, purpose, participants and goal of good clinical practices (GCP). Gives history of GCP staring form Nuremberg code in 1948 to implementation of GCP guidance via WHO handbook in 2005. Also describes Nuremberg's code, declaration of Helsinki and Thirteen principles of GCP.
Describes in detail definition, purpose, participants and goal of good clinical practices (GCP). Gives history of GCP staring form Nuremberg code in 1948 to implementation of GCP guidance via WHO handbook in 2005. Also describes Nuremberg's code, declaration of Helsinki and Thirteen principles of GCP.
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Kiosk-Style Slide Presentation with some interactivity presented at Purdue University Teaching, Learning, and Technology Conference 2003. Must download to fully experience.
Ethics in Clinical Research and Historical Perspective of Nazi Trials, Nuremb...ShantanuThakre3
What is Ethics ?
The word ‘ethics’ is derived from the Greek word,
ethos, which means custom or character. Ethics is
the systematic study of values, so as to decide
what is right and what is wrong. Ethics is concerned
with what is good for individuals and society.
What is Clinical Research ?
Clinical Research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.
Importance of Ethics in Clinical Research :-
1. Ethics is important in clinical research because it keeps the researcher from committing errors while seeking knowledge and truth.
2. Ethical guidelines for clinical research were formulated only after discovery of inhumane behavior with participants during research experiments.
3. In clinical research human beings are involved, as opposed to animals, atoms or asteroids, as the object of study.
4. It focuses on improving human health and well-being, typically by identifying better methods to treat, cure or prevent illnesses.
5. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country
Introduction and History of Clinical ResearchClinosolIndia
Clinical research refers to the scientific study of the safety, efficacy, and effectiveness of medications, medical devices, and treatment interventions in humans. It plays a vital role in advancing medical knowledge, improving patient care, and informing healthcare decision-making. Clinical research encompasses a wide range of studies, including clinical trials, observational studies, and epidemiological research.
Clinical research has a long history, with significant milestones that have shaped its development over time. Here are some key moments in the history of clinical research
1. Origin Of Epidemiology.
2. Definitions Of Epidemiology.
3. Objectives Of Epidemiology.
4. Branches Of Epidemiology.
5. Timeline Of Epidemiology.
6. John Graunt- The First Epidemiologist.
7. James Lind And Scurvy.
8. Edward Jenner And Small Pox.
9. Ignaz Semmelweis And Childbed Fever.
10. John Snow And Cholera
11. Conclusion
Similar to Bhagyashri taralkar elite topic ppt (20)
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.
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.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
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.
Honest Reviews of Tim Han LMA Course Program.pptxtimhan337
Personal development courses are widely available today, with each one promising life-changing outcomes. Tim Han’s Life Mastery Achievers (LMA) Course has drawn a lot of interest. In addition to offering my frank assessment of Success Insider’s LMA Course, this piece examines the course’s effects via a variety of Tim Han LMA course reviews and Success Insider comments.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
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.
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.
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.
1. Name : Bhagyashri Dnyaneshwar Taralkar.
Student of The Elite Institute Of Pharma Skills,Pune.
(www.elite.pharmaskills.com)
Guided By :Mrs. Archana Gawade .
History and Background of Good Clinical Practice
2. History and Background of Good Clinical Practice
Sulfanilamide Disaster
( 1937 )
Thalidomide Disaster
(1962)
Nazi experiments
(1940-1945)
Nurembergs Code
(1947)
1 2
3 4
5 6Tuskegee syphilis Study
(1932-1972)
Belmont Report
(1979)
3. Gerhard Domagk (1932) : Discovered Red Azo Dye Prontosil a
Derivative of Sulfanilamide(1908).
It protected mice from lethal dose of staph and hemolytic
strep He got Nobel prize
January 1932 Animal and Human studies demonstrated
sulfanilamide efficacy in streptococcal infection because first
synthesized in 1908 sulfanilamide was not patentable. Within
months Squib , Merck , Eli lily , Parke Davis each had received
AMA endorsement .
In 1937 S.E Massengill Company of Bristol,
Tennesse , Founded by Samuel E . Massengill
began to produce sulfanilamide solution that had
not been available due to lack of appropriate
vehicle.
Sulfanilamide Disaster
S
1
4. The FDA was notified , and an extensive
research was conducted to recover the
distributed medicines massengill company sent
out 1100 telegrams requesting the return of elixi
.FDA prohibited elixir .
Ys
s
.
After investigating several possible solvents
Harold Watkins ,Massengill chief chemist formulated
raspberry flavor dissolved in
DEG added to sulfa drugs and it was
called Elixir Sulfanilamide and
company marketed the product.
Using DEG as a solvent which is
poisonous To humans but Watkins
the company's chief pharmacist
was not aware of it
(although it was known at time)
The toxicity of the product was never
tested and there were no regulations‘
requiring premarket safety testing of new drugs
By early September1937 ,240 gallons of elixir
sulfanilamide had been manufactured by the
massengill company. The company started
distributing the medication in September 1937.
One of the major points of delivery of the drugs was
Tulsa, Oklahoma.
By October 11, The American
Medical Association received a
report of several deaths caused by
medication
7. The drug was found to be
associated with a congenital
abnormality causing severe birth
defects
Thalidomide was marketed in USA
1957 for morning sickness and
nausea and soon became the drug of
choice to help pregnant women in
first trimester
In 1964 (WMA) World Medical
Assembly has developed guidelines
called as Declaration of Helsinki(DOH)
for ethical conduct of studies
Children's were born with
missing ( amelia ) or abnormal
( phocomelia )legs, arms , feet
and hands
A series of law demonstrated that
large prescriber's had been relying
on manufacturers for the
information about drugs which was
based on inadequate testing
Thalidomide syndrome triggered
world wide response Safety
monitoring system were set to
prevent this tragedy
8. FINLAND
Set of ethical principles
Regarding human experimentation
developed for the medical
community by the world medical
association (WMA).
WMA encourages other participants in medical research involving
human subject to adopt these principles
Declaration is addressed primarily to physician,
The Declaration of Geneva of the wma binds the physicians with
words
It is duty of physician to promote and safeguard the
health of patients including who are involved in research
And the International code of medical ethics declares that ,
A physician shall act in the patients best interest when providing
medical healthcare
The health of my patients will be my first consideration
main purpose: to understand causes , development and effect of
disease and improve preventive, diagnostic and therapeutic
intervention like safety , effectiveness , efficiency , accessibility
Declaration Of Helsinki
9. Many of subject dies as a result of
experiments conducted by Nazis while many
others where after tests where completed
In response , Drs . Leo Alexander and
Andrew Conway Ivy drafted a ten point
memorandum entitled permissible medical
Experiment that went to be known as
Nuremberg code
The code called for such standards as
voluntary consent of patients, avoidance of
unnecessary pain and suffering and that must
be a belief that experimentation will not end
as death
Outcome of Nazi experiments
Nazi Experiment3
10. Freezing Experiments
High Altitude Experiments
Experiments of twins
Experiments with Poisons
Incendiary Bomb Experiments
High Altitude Experiments
Malaria Experiments
Mustard gas Experiments
Sulfonamide Experiments
Sea water Experiments
Sterilization Experiments
List of Nazi experiments
11. Experimentation on twin children's in concentration
camp were created to show similarities and
differences in genetic of twins also to see human
body can be unnaturally manipulated.
It was performed on over 1,500 sets of imprisoned
twins, fewer than 200 survived.
Twins were arranged by age and sex and kept in
barracks between experiments which ranged from
injection of diiferent chemical sinto eye of twins to see
whether it could change the color and literally try
creating conjoined twins at Auschwitz concentration
camp in Poland in may1943
.Twins Experiments
12. Sea Water Experiment
From about July 1944 to about
september1944 Experiment
were conducted in Dachau
concentration camp to study
various method of making sea
water Drinkable
High Altitude Experiment
In early 1942 prisoners at
Dachau camp were used in
experiments to aid German
pilots who had eject at high
altitudes of the 200subjects ,
80 died outright others were
executed
Freezing Experiments
The result of this experiment
were publicized at the 1942
medical conference entitled
Medical Problems Arising from
Sea and winter
Sterilization experiments
From march 1941 to about Jan
1945, Sterilization experiments
were conducted at Auschwitz
,Ravvensbruck ,
It was a try to make a method of
minimum time and efforts for
sterilizing million of peoples
13. Animals experiments first.
Avoid suffering.
Protected from harm.
No intentional death or disability.
Subject free to stop.
Qualified,investigator.
Investigator will stop if harm occurs.
PRINCIPLES OF NUREMBERG CODE
Voluntary Consent.
Anticipate scientific benefits.
Nuremberg Code (1947)4
14. Clinical study conducted in
Tuskegee , Alabama by US
public health service
.Tuskegee Syphilis Study(1932-1972)5
Investigator recruited 399 poor, mostly
illiterate African American sharecroppers
with syphilis for research.
Study began as clinical trial of syphilis in the
Macon County Population.
Initially subjects studied for six to eight months
then treated with contemporary methods
This included Salvarsan , mercurial
ointments and bismuth which were
somewhat effective , but quite toxic
, they were all that was available
People were uninformed about disease
and said to be treated
for bad blood by 1947 penicillin
had become standard treatment for syphilis
15. White people were given penicillin and black
were given placebo just to observe the
progression of fatal disease
By end of the study in 1972, only 74 of test
subjects were alive, 28of the original
And write regulation governing studies invlving human participants On may16,
1997 president Bill Clinton formally apologized and held ceremony for Tuskegee
participants
399 men had died of syphilis , 100 were dies of
related complications , 40 of their wives had been
infected and 19 children's were born with
congenital syphilis in 1974 congress passed the
National research act and created a commission to
study
Tuskegee Syphilis Study(1932-1972)
16. The report was issued on 30 September 1978 and published in federal register on 18
april1979 the report took its name from the Belmont conference center where the document
was drafted as a part
Three core principles are : respect for people, beneficence, and justice Three primary
applications like informed consent, assessment of risks and benefits and selection of
subjects
Today the Belmont report continues as an essential reference for institutional review board
That review HHS conducted proposal involving human subjects meets ethical foundation of
regulation
Created by the National Commission for the protection of human subjects of biomedical And
behavioral Research ,Ethical principles and guidelines for the protection of the human subjects of
research , report of the national commission for the protection of human subjects of biomedical and
behavioral research
Belmont Report6