This document provides an overview of the International Council for Harmonisation (ICH). It explains that ICH aims to reduce differences between countries' regulatory guidelines for pharmaceuticals through harmonization. It describes ICH's organization, including its members, observers, and management committees. Finally, it outlines ICH's harmonization process and lists some of its guidelines and successes in harmonizing technical requirements to help ensure safe, effective medicines for patients worldwide.
Registration of Indian Drug Product in Overseas Market.pptxNipun Gupta
This includes the following contents:
1. Introduction
2. Procedure for Export of products
3. Technical Documentations
MFR, BMR, COA, COPP
4. Drug Master File
5. Common Technical Document
6. Electronic Common Technical Documents
7. ASEAN Common Technical Document
What is a Variation…?
Variation regulations and guidelines
Types of variations
Type-IA
Type-IB
Type-II
Extension
Unforeseen variations (Z category)
Grouping of variations
Work sharing of variations
Fee
eAF
Renewals
TSE/BSE is a type of disease affected to the animals which may transmit to the humans if any products obtained by the disease caused animal may affect to humans also
The many biologic products are expracted from the animal source so before the extraction the animal should be tested for TSE/BSE organism in their source/Body
IIMPORT AND REGISTRATION AS PER DRUG AND COSMETIC ACT Sagar Savale
The drug and cosmetic act was passed on 10th April, 1940.
Objective : To regulate the import, manufacture, distribution, and sale of Drug and Cosmetics.
All classes of the drugs and cosmetics imported into India, shall comply with the prescribed standards and labels.
Manufacture of all classes of drug require prior license.
ICH -International Council for Harmonization overview ,and guidelinesDivy Patel
ICH -International Council for Harmonization overview , organizational chart and guidelines including photos , websites and insider infos, including members with their native regions...
Registration of Indian Drug Product in Overseas Market.pptxNipun Gupta
This includes the following contents:
1. Introduction
2. Procedure for Export of products
3. Technical Documentations
MFR, BMR, COA, COPP
4. Drug Master File
5. Common Technical Document
6. Electronic Common Technical Documents
7. ASEAN Common Technical Document
What is a Variation…?
Variation regulations and guidelines
Types of variations
Type-IA
Type-IB
Type-II
Extension
Unforeseen variations (Z category)
Grouping of variations
Work sharing of variations
Fee
eAF
Renewals
TSE/BSE is a type of disease affected to the animals which may transmit to the humans if any products obtained by the disease caused animal may affect to humans also
The many biologic products are expracted from the animal source so before the extraction the animal should be tested for TSE/BSE organism in their source/Body
IIMPORT AND REGISTRATION AS PER DRUG AND COSMETIC ACT Sagar Savale
The drug and cosmetic act was passed on 10th April, 1940.
Objective : To regulate the import, manufacture, distribution, and sale of Drug and Cosmetics.
All classes of the drugs and cosmetics imported into India, shall comply with the prescribed standards and labels.
Manufacture of all classes of drug require prior license.
ICH -International Council for Harmonization overview ,and guidelinesDivy Patel
ICH -International Council for Harmonization overview , organizational chart and guidelines including photos , websites and insider infos, including members with their native regions...
International Federation of Accountants-IFACSultan Mahmood
IFAC
is the global organization
for the accountancy
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serving the public interest
by strengthening the
profession and contributing to the development of strong
international economies.
IFAC
is comprised of over 175
members and associates in
more than 130 countries and
jurisdictions, representing almost
3 million accountants in public
practice, education,
government service, industry,
and commerce.
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.
Presented by Leen Meulenbergs
WHO Representative to the European Union and
Executive Manager for Strategic Partnerships (PAR) in the WHO European Union, at the 66th Session of the WHO Regional Committee for Europe.
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.
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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!
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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.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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.
- 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
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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
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
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
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.
2. • What does ICH stand for?
• Initiation of ICH
• The Evolution of ICH
• What is the purpose of ICH?
• Organisation of ICH
• Members & Observers
• ICH Harmonization Process
• ICH Guidelines
3. What does ICH stand for?
The International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH)
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use
The International Council for Harmonisation (ICH), formerly the International
Conference on Harmonisation (ICH) held the inaugural Assembly meetings on 23
October 2015 establishing ICH as an international association, a legal entity under
Swiss law
What for
• Decrease country-to-country differences in guidelines
• Decrease differences between regulatory authorities
4. Initiation of ICH
Harmonisation of regulatory requirements was started by the EC, Europe, in the
1980s, as the EC, Europe moved towards the development of a single market for
pharmaceuticals.
At the same time there were discussions between Europe, Japan and the US on
possibilities for harmonisation.
It was, however, at the WHO Conference of Drug Regulatory Authorities (ICDRA),
in Paris, in 1989, that specific plans for action began to materialise. Soon
afterwards, the authorities approached International Federation of Pharmaceutical
Manufacturers and Associations (IFPMA) to discuss a joint regulatory-industry
initiative on international harmonisation, and ICH was conceived.
The birth of ICH took place at a meeting in April 1990, hosted by EFPIA in
Brussels.
5. The Evolution of ICH
Since ICH's inception in 1990, the ICH process has gradually evolved.
ICH's first decade saw significant progress in the development of ICH Guidelines on
Safety, Quality and Efficacy topics. Work was also undertaken on a number of
important multidisciplinary topics, which included MedDRA (Medical Dictionary
for Regulatory Activities) and the CTD (Common Technical Document).
As ICH started into a new millennium, the need to expand communication and
dissemination of information on ICH Guidelines with non-ICH regions became a
key focus.
6. What is the purpose of ICH?
Promotion of public health through international harmonisation that contributes to:
• Prevention of unnecessary duplication of clinical trials and post market clinical
evaluations
• Development and manufacturing of new medicines
• Registration and supervision of new medicines
• Reduction of unnecessary animal testing without compromising safety and
effectiveness
Accomplished through Technical Guidelines that are implemented by the regulatory
authorities.
7. • Faster access to medicines around the world
• Better use of limited resources
• Reduced duplication
• Sharing experience and knowledge
• Fewer clinical trials needed
• Fewer animals needed for basic research
• Training and capacity building with regulators and industry will be key
What is the purpose of ICH?
9. The Auditors are appointed for a period of two years and may be re-appointed. The responsibility of
the Auditors is to audit the financial statements of the Association upon conclusion of each Fiscal
Year.
ICH Assembly brings together all Members and Observers of the ICH Association as the overarching
governing body of ICH.
ICH Management Committee (MC) is the body that oversees operational aspects of ICH on behalf of
all Members, including administrative and financial matters and oversight of the Working Groups
(WGs). The MC is responsible for submitting recommendations or proposals to the Assembly in
preparation of Assembly discussions
MedDRA Management Committee (MC) has responsibility for direction of MedDRA, an ICH
standardised dictionary of medical terminology.
ICH Secretariat is responsible for day-to-day management of ICH, coordinating ICH activities as
well as providing support to the Assembly, the ICH Management Committee and its Working Groups.
The ICH Secretariat also provides support for the ICH MedDRA Management Committee. The
Secretariat is located in Geneva, Switzerland
10. ICH Coordinators
Fundamental to the smooth running of ICH has been the designation of an ICH Coordinator per ICH
Member to act as the main contact point with the ICH Secretariat. Coordinators ensure proper
distribution of ICH documents to the appropriate persons from their organisation and are responsible
for the follow up on actions within their respective organisation within assigned deadlines. They also
assist communication between the ICH Management Committee and/or Assembly and the ICH
Working Groups as needed.
An ICH Working Group (WG) is established for each technical topic selected for harmonisation.
• There are several different types of ICH working group:
• EWG: Expert Working Group is charged with developing a harmonised guideline that meets the
objectives in the Concept Paper and Business Plan.
• IWG: Implementation Working Group is tasked with developing Q&As to facilitate
implementation of existing guidelines.
• Informal Working Group: Is formed prior to any official ICH harmonisation activity with the
objectives of developing/finalising a Concept Paper, as well as developing a Business Plan.
• Discussion Group: Is a group established to discuss specific scientific considerations or views i.e.
Gene Therapy Discussion Group (GTDG), and ICH & Women Discussion Group.