ICH GCP guidelines for mpharmacy 2nd sem 204T subject.
topic include the brief description regarding ICH GCP
THE GOOD CLINICAL PRACTICES AND
THE INTERNATIONAL CONFERENCE OF HORMONIZATION.
THAT INCLUDE the regulation of all pharmaceutical industries.
Laws and Guidelines on Clinical Trials in India.pptxmehulsarathy
Diving into the Regulatory Framework: Navigating Clinical Trial Laws & Guidelines in India. This academic presentation offers an in-depth analysis of the legal landscape governing clinical research in India. Delve into the intricate web of regulations, ethical principles, and participant protection measures outlined by the Drugs and Cosmetics Act, ICMR guidelines, and recent amendments.
Clinical research plays a vital role in advancing medical knowledge, developing new treatments, and improving patient care. However, conducting clinical trials involves numerous ethical and regulatory considerations to ensure participant safety, data integrity, and compliance with applicable laws and guidelines.
Introduction to Clinical Research RegulationsClinosolIndia
Clinical research plays a vital role in advancing medical knowledge, developing new treatments, and improving patient care. However, conducting clinical trials involves numerous ethical and regulatory considerations to ensure participant safety, data integrity, and compliance with applicable laws and guidelines.
ICH GCP guidelines for mpharmacy 2nd sem 204T subject.
topic include the brief description regarding ICH GCP
THE GOOD CLINICAL PRACTICES AND
THE INTERNATIONAL CONFERENCE OF HORMONIZATION.
THAT INCLUDE the regulation of all pharmaceutical industries.
Laws and Guidelines on Clinical Trials in India.pptxmehulsarathy
Diving into the Regulatory Framework: Navigating Clinical Trial Laws & Guidelines in India. This academic presentation offers an in-depth analysis of the legal landscape governing clinical research in India. Delve into the intricate web of regulations, ethical principles, and participant protection measures outlined by the Drugs and Cosmetics Act, ICMR guidelines, and recent amendments.
Clinical research plays a vital role in advancing medical knowledge, developing new treatments, and improving patient care. However, conducting clinical trials involves numerous ethical and regulatory considerations to ensure participant safety, data integrity, and compliance with applicable laws and guidelines.
Introduction to Clinical Research RegulationsClinosolIndia
Clinical research plays a vital role in advancing medical knowledge, developing new treatments, and improving patient care. However, conducting clinical trials involves numerous ethical and regulatory considerations to ensure participant safety, data integrity, and compliance with applicable laws and guidelines.
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (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.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
Ethical Dimensions in the Biomedical Innovations in India: An AnalysisAnup Kumar Das
Presentation titled "Ethical Dimensions in the Biomedical Innovations in India: An Analysis" was presented in the Second International Convention on Ethics in Research on Human Participants: Evolving Norms and Guidelines for the Indian Context, 2-4 September 2014, at JNU Convention Centre, New Delhi; Organized by Institutional Ethics Review Board, JNU, India.
What is The Clinical Trial Approval Process In India.pdfPranshuCorpseed
Clinical trials are critical in the development of novel medications and cures, advancing medical science and patient care. The clinical trial ecosystem in India has grown dramatically, making it an appealing destination for pharmaceutical research. This article explores the regulatory framework, ethical concerns, phases of clinical trials, application processes, review, post-approval requirements, obstacles, case studies, and future prospects of clinical trial approval in India.
International Conference on Harmonisation (ICH) was created in 1990
Agreement between the EU, Japan, and the USA to harmonize different regional requirements for registration of pharmaceutical drug products.
This document describes the detailed information of clinical trial protocol and protocol design. The protocol includes the key information of study designs. This document is downloaded as a PDF and viewed online.
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (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.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
Ethical Dimensions in the Biomedical Innovations in India: An AnalysisAnup Kumar Das
Presentation titled "Ethical Dimensions in the Biomedical Innovations in India: An Analysis" was presented in the Second International Convention on Ethics in Research on Human Participants: Evolving Norms and Guidelines for the Indian Context, 2-4 September 2014, at JNU Convention Centre, New Delhi; Organized by Institutional Ethics Review Board, JNU, India.
What is The Clinical Trial Approval Process In India.pdfPranshuCorpseed
Clinical trials are critical in the development of novel medications and cures, advancing medical science and patient care. The clinical trial ecosystem in India has grown dramatically, making it an appealing destination for pharmaceutical research. This article explores the regulatory framework, ethical concerns, phases of clinical trials, application processes, review, post-approval requirements, obstacles, case studies, and future prospects of clinical trial approval in India.
International Conference on Harmonisation (ICH) was created in 1990
Agreement between the EU, Japan, and the USA to harmonize different regional requirements for registration of pharmaceutical drug products.
This document describes the detailed information of clinical trial protocol and protocol design. The protocol includes the key information of study designs. This document is downloaded as a PDF and viewed online.
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.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
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.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
- 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
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
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ICH & ICMR
1. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
Subject : Modern bio analytical techniques
Topic : ICH Guidelines and ICMR Guidelines
Presented By,
VENKATESAN R
(Reg No : 22PA023) (2nd Sem)
M. Pharm Pharmaceutical analysis,
Presented to,
Dr. Harsha K Tripathy,
Department of Pharmaceutical analysis
2. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
Content:
• Guidelines of ICH
• Guidelines of ICMR
2
3. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
1. ICH
• Definition:
International Council for Hormonization of technical
requirements for pharmaceutical for human use.
Regulatory authorities Pharmaceutical Industry
ICH Bring together
to scientific and technical aspects of drug registration
3
ICH is a joint initiative involving both the regulators and the industry
as equal partners in the scientific and technical discussions of the
testing procedures which are required to ensure and assess the safety,
quality and efficacy of medicines.
4. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
The ICH topics are divided into four categories and ICH topic codes are assigned
according to these categories.
1. Efficacy (E1-E20):
clinical trials etc
2. Safety (S1-S11):
pharmacovigilance, adverse drug reaction reporting
3. Quality (Q1-Q14):
raw materials, impurities, residual solvents etc
4. Multidisciplinary (M1- M12):
common technical document, electronic submission, coding systems.
4
5. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
ICH Member / Parties:
6 parties
• EU
• EFPIA (European federation of pharmaceutical industries Associations)
• MHLW (Ministry of health, Labor and welfare), Japan
• JPMA (Japan Pharmaceuticals manufacturers Association)
• US FDA
• PhRMA ( Pharmaceutical Research and Medical Association)
• Observers : WHO, TPP (canada)
• International federation of Pharmaceutical manufacturer’s association
5
6. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
ICH GCP guideline
1. Glossary:
Common language for investigators/sponsors/ethics committees
2. Principles of Good Clinical Practice:
13 tenets of ICH GCP
3. Requirements for IRB/IEC
Roles responsibilities and composition
4. Responsibilities of the investigator
5. Responsibilities of the sponsor
6
7. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
6. Requirements for clinical trial protocol
and protocol amendments
7. Responsibility of the sponsor in the development of investigator’s
brochure.
8. Essential documents.
7
9. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
Good Clinical Practices (GCP) is an international ethical &scientific
quality standard for designing, conducting, recording &reporting
trials that involve the participation of human subjects.
• To ensure the rights, safety and well being of the trial subjects are
protected.
• Ensure the credibility of clinical trial data.
9
10. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
10
1. ICMR -Indian Council of Medical Research
• One of the oldest medical research body in the world ICMR, New
Delhi.
• It is national agencies for planning, formulation, co-ordination,
implementation.
• In 1911, government of india set up the Indian research fund association
sponsoring and co ordinating medical research in country.
• After independence, several important changes made in IRFA.
11. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
• It was redesigned the ICMR in 1949 with expanded scope of function
and responsibilities
• ICMR funded by Government of india through Ministry of Health,
Family and welfare.
• It is not only planning and promoting it build strong national group.
• Rapid advances in science and technology have brought in new
technologies to understand the disease process and find strategies for
prevention and cure.
11
12. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
Guidelines:
• Guidelines on transfer of human biological material for research
• Dietary guidelines for Indians.
• Cancer management guidelines.
• Guidelines for good clinical laboratory practices.
• Ethical guidelines for biomedical research on human participants.
• Control and management of communicable disease, facility control,
maternal and child health.
12
13. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
Objective:
ICMR, with its 30 state of the art institutes/centers, is amongst
research organizations in the field of bio medical sciences.
• The Indian council of medical research provides financial assistance to
promote biomedical and health research.
• Proposals in fundamental research, development and evaluation of a tool,
clinical and operational research are considered for ICMR support.
13
14. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
Indian Council of Medical Research
Abbreviation ICMR
1. Type Professional Organization
2. Headquarters New Delhi
3. Region served India
4. Secretary and director general Dr. V. M. Katoch
5. Website http://www.icmr.nic.in/
14
15. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
Intramural Research
Intramural research is carried out currently through the council’s 30
research institutes/centers.
These includes,
1. 19 mission oriented national institutes.
2. 6 Regional Medical Research centers.
3. 5 Units/Centers
15
16. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
Extramural research
Extramural research is promoted by ICMR though setting up
• Centres for advanced research in selected departments of medical colleges,
universities and other non-ICMR research institites.
• Task force studies with goal oriented approach with clearly defined targets.
• Open ended research in non ICMR research institutes, medical colleges,
universities etc. located in different parts of the country
16
17. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
Fellowship and schemes
The ICMR encourage human resources development in biomedical
research through various schemes such as
1. Research fellowships
2. Short term visiting fellowships
3. Short term research studentships
17
18. KARNATAKA COLLEGE OF PHARMACY
BANGALORE
4. Various training program and workshops conducted by ICMR
institutes and headquarters.
National Health Programmes:
• National Malaria eradication programme
• National Filaria control Programme
• National leprosy control programme
• Diarrhoeal disease control programme
• National AIDS control programme
• National cancer control programme
• National tuberculosis programme
18
