The International Council for Harmonisation (ICH) brings together regulatory authorities and the pharmaceutical industry to discuss technical requirements for drugs. Formed in 1990, ICH aims to harmonize regulations globally to ensure safe, effective, high-quality medicines are developed efficiently. ICH guidelines cover Quality, Safety, Efficacy, and Multidisciplinary topics related to drug development and approval processes. The document provides an overview of ICH guidelines for each of these areas.
Key importance of ICH guideline, a brief summary on the international guidelines for new drug development.
Specifically for regulatory affairs student of MPharm
In this slide contains a ICH guideleine for Quality, Safety , Efficacy and Multidisciplinary
Quality
Guidelines
Safety Guidelines
Efficacy Guidelines
Multidisciplinary
Guidelines
It is unique in bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
The International Classification of Diseases (ICD) is a globally recognized system for classifying and coding diseases, health conditions, and related factors. It is maintained and updated by the World Health Organization (WHO) and serves several critical functions in healthcare and epidemiology. To describe the ICD comprehensively within 3000 characters, we'll cover its history, purpose, structure, and significance.
**History:**
The roots of the ICD can be traced back to the mid-19th century when various countries began documenting statistics on causes of death. The need for a standardized classification system became evident as different nations used their own systems, hindering international comparisons. The ICD was officially established in its modern form in 1948, with subsequent revisions and updates.
**Purpose:**
The primary purposes of the ICD are as follows:
1. **Disease Classification:** The ICD provides a systematic way to categorize diseases and health conditions. Each condition is assigned a unique code, which simplifies data collection and reporting.
2. **Clinical Diagnosis:** Healthcare professionals use the ICD to document and communicate diagnoses. This aids in patient care, medical billing, and insurance claims processing.
3. **Epidemiology:** The ICD is crucial for monitoring and analyzing disease patterns on a global scale. It helps identify emerging health threats, allocate resources, and develop public health policies.
4. **Health Statistics:** Governments and health organizations use the ICD to compile health statistics, such as causes of death and disease prevalence. This information guides healthcare planning and resource allocation.
**Structure:**
The ICD is organized into chapters, sections, and codes. The current version, ICD-10, is divided into 22 chapters, covering a wide range of health-related topics. Here's an overview of some key chapters:
- **Chapter I:** Certain infectious and parasitic diseases
- **Chapter II:** Neoplasms (cancers)
- **Chapter III:** Diseases of the blood and blood-forming organs
- **Chapter IV:** Endocrine, nutritional, and metabolic diseases
- **Chapter V:** Mental and behavioral disorders
- **Chapter VI:** Diseases of the nervous system
- **Chapter VII:** Diseases of the eye and adnexa
- **Chapter VIII:** Diseases of the ear and mastoid process
- **Chapter IX:** Diseases of the circulatory system
- **Chapter X:** Diseases of the respiratory system
- **Chapter XI:** Diseases of the digestive system
- **Chapter XII:** Diseases of the skin and subcutaneous tissue
- **Chapter XIII:** Diseases of the musculoskeletal system and connective tissue
- **Chapter XIV:** Diseases of the genitourinary system
- **Chapter XV:** Pregnancy, childbirth, and the puerperium
- **Chapter XVI:** Certain conditions originating in the perinatal period
- **Chapter XVII:** Congenital malformations, deformations, and chromosomal abnormalities
- **Chapter XVIII:** Symptoms, signs, and abnormal clinical and labor
Key importance of ICH guideline, a brief summary on the international guidelines for new drug development.
Specifically for regulatory affairs student of MPharm
In this slide contains a ICH guideleine for Quality, Safety , Efficacy and Multidisciplinary
Quality
Guidelines
Safety Guidelines
Efficacy Guidelines
Multidisciplinary
Guidelines
It is unique in bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
The International Classification of Diseases (ICD) is a globally recognized system for classifying and coding diseases, health conditions, and related factors. It is maintained and updated by the World Health Organization (WHO) and serves several critical functions in healthcare and epidemiology. To describe the ICD comprehensively within 3000 characters, we'll cover its history, purpose, structure, and significance.
**History:**
The roots of the ICD can be traced back to the mid-19th century when various countries began documenting statistics on causes of death. The need for a standardized classification system became evident as different nations used their own systems, hindering international comparisons. The ICD was officially established in its modern form in 1948, with subsequent revisions and updates.
**Purpose:**
The primary purposes of the ICD are as follows:
1. **Disease Classification:** The ICD provides a systematic way to categorize diseases and health conditions. Each condition is assigned a unique code, which simplifies data collection and reporting.
2. **Clinical Diagnosis:** Healthcare professionals use the ICD to document and communicate diagnoses. This aids in patient care, medical billing, and insurance claims processing.
3. **Epidemiology:** The ICD is crucial for monitoring and analyzing disease patterns on a global scale. It helps identify emerging health threats, allocate resources, and develop public health policies.
4. **Health Statistics:** Governments and health organizations use the ICD to compile health statistics, such as causes of death and disease prevalence. This information guides healthcare planning and resource allocation.
**Structure:**
The ICD is organized into chapters, sections, and codes. The current version, ICD-10, is divided into 22 chapters, covering a wide range of health-related topics. Here's an overview of some key chapters:
- **Chapter I:** Certain infectious and parasitic diseases
- **Chapter II:** Neoplasms (cancers)
- **Chapter III:** Diseases of the blood and blood-forming organs
- **Chapter IV:** Endocrine, nutritional, and metabolic diseases
- **Chapter V:** Mental and behavioral disorders
- **Chapter VI:** Diseases of the nervous system
- **Chapter VII:** Diseases of the eye and adnexa
- **Chapter VIII:** Diseases of the ear and mastoid process
- **Chapter IX:** Diseases of the circulatory system
- **Chapter X:** Diseases of the respiratory system
- **Chapter XI:** Diseases of the digestive system
- **Chapter XII:** Diseases of the skin and subcutaneous tissue
- **Chapter XIII:** Diseases of the musculoskeletal system and connective tissue
- **Chapter XIV:** Diseases of the genitourinary system
- **Chapter XV:** Pregnancy, childbirth, and the puerperium
- **Chapter XVI:** Certain conditions originating in the perinatal period
- **Chapter XVII:** Congenital malformations, deformations, and chromosomal abnormalities
- **Chapter XVIII:** Symptoms, signs, and abnormal clinical and labor
ICH is stand for the “International Conference on Harmonization of Technical Requirement for Pharmaceuticals for Human Use”
Goal of ICH. ICH Guidelines.
Q (Quality) S (Safety)
Related to chemical & pharmaceutical Quality Assurance ( Stability Testing, Impurity Testing etc.)
Related to in vitro & in vivo pre-clinical studies (Carcinogenicity Testing, genotoxicity Testing, etc.)
Stability testing of new drug substances and products.
Validation of Analytical Procedures : Text & Methodology
Regulatory Acceptance of Analytical Procedure &Acceptance Criteria (RAAPAC)
Carcinogenicity Studies (S1A-S1C)
ICH Guidelines of Quality, Safety, Efficacy and Multidisciplinary guidelines that implemented by International Council for Harmonisation. ich stands for the harmonisation of Technical requirements of Pharmaceuticals for Human use.
ICH GUIDELINES, ICH, INTERNATIONAL CONFERENCE ON HARMONIZATION, B PHARMA 6TH SEM, PHARMACEUTICAL QUALITY ASSURANCE
ICH and ICH guidelines
Need
Origin of ICH
Evolution of ICH
ICH members
Steps of ICH
STEP 1: Building Scientific Consensus
STEP 2: Agreeing on Draft Text
STEP 3: Consulting Regional Regulatory Agencies
STEP 4: Adopting Harmonized Guidelines
STEP 5: Implementing Guidelines in ICH Regions
Categories of ICH guidelines
ICH's mission to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration thereby reducing duplication of testing and reporting carried out during research and development of new medicines.
Regulatory guidelines for conducting toxicity studies by ichAnimatedWorld
ICH is the “International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for
Human Use”
ICH is a joint initiative involving both regulators and research based industry representatives of the EU, Japan and the US in
scientific and technical discussions of the testing procedures required
to assess and ensure the safety, quality and efficacy of medicines
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.
ICH is stand for the “International Conference on Harmonization of Technical Requirement for Pharmaceuticals for Human Use”
Goal of ICH. ICH Guidelines.
Q (Quality) S (Safety)
Related to chemical & pharmaceutical Quality Assurance ( Stability Testing, Impurity Testing etc.)
Related to in vitro & in vivo pre-clinical studies (Carcinogenicity Testing, genotoxicity Testing, etc.)
Stability testing of new drug substances and products.
Validation of Analytical Procedures : Text & Methodology
Regulatory Acceptance of Analytical Procedure &Acceptance Criteria (RAAPAC)
Carcinogenicity Studies (S1A-S1C)
ICH Guidelines of Quality, Safety, Efficacy and Multidisciplinary guidelines that implemented by International Council for Harmonisation. ich stands for the harmonisation of Technical requirements of Pharmaceuticals for Human use.
ICH GUIDELINES, ICH, INTERNATIONAL CONFERENCE ON HARMONIZATION, B PHARMA 6TH SEM, PHARMACEUTICAL QUALITY ASSURANCE
ICH and ICH guidelines
Need
Origin of ICH
Evolution of ICH
ICH members
Steps of ICH
STEP 1: Building Scientific Consensus
STEP 2: Agreeing on Draft Text
STEP 3: Consulting Regional Regulatory Agencies
STEP 4: Adopting Harmonized Guidelines
STEP 5: Implementing Guidelines in ICH Regions
Categories of ICH guidelines
ICH's mission to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration thereby reducing duplication of testing and reporting carried out during research and development of new medicines.
Regulatory guidelines for conducting toxicity studies by ichAnimatedWorld
ICH is the “International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for
Human Use”
ICH is a joint initiative involving both regulators and research based industry representatives of the EU, Japan and the US in
scientific and technical discussions of the testing procedures required
to assess and ensure the safety, quality and efficacy of medicines
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.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
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
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
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.
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.
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
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!
2. PHARMA
BABA
INTRODUCTION
The International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH) is
unique in bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and technical
aspects of pharmaceuticals and develop ICH guidelines.
Inception in 1990.
ICH's mission is to achieve greater harmonisation worldwide
to ensure that safe, effective and high quality medicines are
developed, and registered and maintained in the most resource
efficient manner whilst meeting high standards.
2
3. PHARMA
BABA
INTRODUCTION
ICH GUIDELINES (Q S E M)
Q Quality for e. g. conduct of stability studies, defining
relevant thresholds for impurities testing and a more flexible
approach to pharmaceutical quality based on Good
Manufacturing Practice (GMP) risk management.
3
S Safety to uncover potential risks like carcinogenicity,
genotoxicity and reprotoxicity. A recent breakthrough has been a
non-clinical testing strategy for assessing the QT interval
prolongation liability: the single most important cause of drug
withdrawals in recent years.
4. PHARMA
BABA
INTRODUCTION
ICH GUIDELINES (Q S E M)
E Efficacy is concerned with the design, conduct, safety and
reporting of clinical trials. It also covers novel types of
medicines derived from biotechnological processes and the use
of pharmacogenetics/genomics techniques to produce better
targeted medicines.
4
M Multidisciplinary Those are the cross-cutting topics which
do not fit uniquely into one of the Quality, Safety and Efficacy
categories. It includes the ICH medical terminology (MedDRA),
the Common Technical Document (CTD) and the development
of Electronic Standards for the Transfer of Regulatory
Information (ESTRI).
5. PHARMA
BABA
Stability Q1A-Q1F
Analytical Validation Q2
Impurities Q3A-Q3E
Pharmacopoeias Q4A-Q4B
Quality of Biotechnological Products Q5A-Q5B
Specifications Q6A-Q6B
Good Manufacturing Practice Q7
Pharmaceutical Development Q8
Quality Risk Management Q9
Pharmaceutical Quality System Q10
Development and Manufacture of Drug substances Q11
Life cycle management Q12
Continuous manufacturing of Drug substances and Drug products Q13
Analytical procedure development Q14
5
Quality
Guidelines
7. PHARMA
BABA
Clinical safety for drugs used in long-term treatment E1
Pharmacovigilance E2A-E2F
Clinical study reports E3
Dose-response studies E4
Ethnic factors E5
Good clinical practice E6
Clinical trials in geriatric population E7
General considerations for clinical trials E8
Statistical principals for clinical trials E9
Choice of control group in clinical trials E10
Clinical trials in pediatric population E11-E11A
Clinical evaluation by therapeutic category E12
Clinical evaluation of QT E14
Definitions in Pharmacogenetics / Pharmacogenomics E15
Qualification of genomic biomarkers E16
Multi-Regional clinical trials E17
Genomic sampling E18
Safety data collection E19
Adaptive clinical trials E20
7
Efficacy
Guidelines
8. PHARMA
BABA MedDRA terminology M1
Electronic standards M2
Nonclinical safety studies M3
Common technical document M4
Data elements and standards for drug dictionaries M5
Gene therapy M6
Mutagenic impurities M7
Electronic common technical document (eCTD) M8
Biopharmaceutics classification system based biowaviers M9
Bioanalytical method validation and study sample analysis M10
Clinical electronic structured harmonized protocol (CeSHarP) M11
Drug interaction studies M12
Bioequivalence for Immediate-Release Solid Oral Dosage Forms M13
Use of real-world data in pharmacological studies M14
8
Multidisciplinary
Guidelines