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 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
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 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 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.
Key importance of ICH guideline, a brief summary on the international guidelines for new drug development.
Specifically for regulatory affairs student of MPharm
intertnational council for harmonization The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects Details of the ICH guidelines for pharmaceutical quality from Q1 to Q12 including stability analysis, evaluation of impurities and quality risk management. ICH (Full form = International Conference on Harmonisation) is a committee that provides the pharmaceutical guidelines for industries.
It is unique in bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
ICH - International Conference on Harmonization of Technical Requirements for Registration
of Pharmaceuticals for Human Use. It was created in 1990.
ICH established in 1990 as a joint initiative involving both regulators and research-based
industry representatives of the European Union, Japan and the USA in scientific and technical
discussion of the testing procedures required to assess and ensure the safety, quality and
efficacy of medicines.
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.
Key importance of ICH guideline, a brief summary on the international guidelines for new drug development.
Specifically for regulatory affairs student of MPharm
intertnational council for harmonization The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects Details of the ICH guidelines for pharmaceutical quality from Q1 to Q12 including stability analysis, evaluation of impurities and quality risk management. ICH (Full form = International Conference on Harmonisation) is a committee that provides the pharmaceutical guidelines for industries.
It is unique in bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
ICH - International Conference on Harmonization of Technical Requirements for Registration
of Pharmaceuticals for Human Use. It was created in 1990.
ICH established in 1990 as a joint initiative involving both regulators and research-based
industry representatives of the European Union, Japan and the USA in scientific and technical
discussion of the testing procedures required to assess and ensure the safety, quality and
efficacy of medicines.
How to Split Bills in the Odoo 17 POS ModuleCeline George
Bills have a main role in point of sale procedure. It will help to track sales, handling payments and giving receipts to customers. Bill splitting also has an important role in POS. For example, If some friends come together for dinner and if they want to divide the bill then it is possible by POS bill splitting. This slide will show how to split bills in odoo 17 POS.
The Art Pastor's Guide to Sabbath | Steve ThomasonSteve Thomason
What is the purpose of the Sabbath Law in the Torah. It is interesting to compare how the context of the law shifts from Exodus to Deuteronomy. Who gets to rest, and why?
The Indian economy is classified into different sectors to simplify the analysis and understanding of economic activities. For Class 10, it's essential to grasp the sectors of the Indian economy, understand their characteristics, and recognize their importance. This guide will provide detailed notes on the Sectors of the Indian Economy Class 10, using specific long-tail keywords to enhance comprehension.
For more information, visit-www.vavaclasses.com
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
1.4 modern child centered education - mahatma gandhi-2.pptx
ICH PPT
1. PRESENTED BY:
APOORVA MISHRA
M.PHARM (PHARMACOLOGY)
Ist Semester
GUIDED BY:
DR. SAUMYA DA
ASSOCIATE PROFESSOR
NIET (PHARMACY INSTITUTE)
INTERNATIONAL COUNCIL FOR HARMONIZATION
2. ICH stands for "International Conference on
Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use".
ICH is a joint initiative of the regulatory authorities and
pharmaceutical industries of European Union, Japan
and the USA for the scientific and technical discussions
of the testing procedures required to assess and ensure
the safety, quality and efficacy of medicines.
3. To increase safety, efficacy and quality of medicine
To harmonize technical requirement for registration or
marketing approval.
To develop & register pharmaceutical in efficient &
cost effective manner.
To prevent unnecessary duplication of clinical trial on
human.
To minimize use of animal testing without
compromising safety & efficacy of drugs.
4. Promote public health by early availability of drug in the
market.
Maintaining safeguards on quality, safety and efficacy.
Improve efficiency of new drug development Reduce
registration cost.
Less expensive drugs for patients.
Prevent the duplication of clinical trails in humans.
Minimize the animal use with out compromising in safety
efficacy of the product.
Mutual acceptance of clinical data by regulatory authority.
Reducing testing duplication.
5. To promote international harmonization.
To discuss and establish common guidelines.
To provide information on ICH activities to other
countries.
To promote understanding of initiative and facilitate
harmonization globally.
To strengthen capacity of drug regulatory authorities
and industry to utilize them.
6. Harmonization of regulatory requirements was pioneered
by the EU, Europe, in the 1980s as the Europe move
towards the development of single market.
The success achieved in Europe demonstrated that
harmonization was feasibile. At the same time there were
discussions between Europe, Japan and the US on
possibilities for harmonization. The birth of ICH took place
at a meeting in April 1990. Topics selected for
harmonisation would be divided into safety, quality and
efficacy to reflect the three criteria which are the basis for
approving and authorising new medicinal products.
7. First decade : Significant progress in the development
of ICH Guidelines on Safety, Quality and Efficacy
topics and also work on a number of important
multidisciplinary topics.
Second decade : Implementation of ICH Guidelines in
the ICH regions. Expand communication and
information on ICH Guidelines with other regions.
Third decade : Extending the benefits of harmonisation
beyond the ICH regions. Training,as well as active
participation of other regions in Guideline development
is seen as key in this effort.
8. 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 manufacturers
association)
10. STEP 5-Implementing Guidelines in ICH Regions
STEP 4-Adopting Harmonized Guidelines
STEP 3-Consulting Regional Regulatory Agencies
STEP 2-Agreeing on Draft Text
STEP 1-Building Scientific Consensus
12. QUALITY: Harmonization achievements in the Quality
area include such as the 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.
SAFETY: ICH has produced a comprehensive set of
safety Guidelines to potential risks like carcinogenicity,
genotoxicity and reprotoxicity etc.
13. EFFICACY: The work carried out by ICH under the
Efficacy heading 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.
MULTIDISCPLINARY: These 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).
14. QIA-QIF: Stability
Q2: Analytical Validation
Q3A-Q3D: Impurities
Q4-Q4B: Pharmacopoeias
Q5A-Q5E: Quality of Biotechnological Products
Q6A-Q6B: Specifications
Q7: Good Manufacturing Practice
Q8: Pharmaceutical Development
Q9: Quality Risk Management
Q10: Pharmaceutical Quality System
Q11: Development and Manufacture of Drug Substances
Q12: Lifecycle Management
Q13: Continuous Manufacturing of Drug Substances and Drug Products
Q14: Analytical Procedure Development
16. E1: Clinical Safety for Drugs used in Long-Term Treatment
E2A - E2F : Pharmacovigilance
E3: Clinical Study Reports
E4: Dose-Response Studies
E5: Ethnic Factors
E6: Good Clinical Practice
E7 :Clinical Trials in Geriatric Population
E8: General Considerations for Clinical Trials
E9 Statistical Principles for Clinical Trials
E10: Choice of Control Group in Clinical Trials
E11: Clinical Trials in Pediatric Population
E12 Clinical Evaluation by Therapeutic Category
E14 Clinical Evaluation of QT
E15 Definitions in Pharmacogenetics / Pharmacogenomics
E17: Multi-Regional Clinical Trials
E18: Genomic Sampling
17. M1: MedDRA Terminology
M2: Electronic Standards
M3: Nonclinical Safety Studies
M4: Common Technical Document
M5: Data Elements and Standards for Drug Dictionaries
M6: Gene Therapy
M7: Mutagenic impurities
M8: Electronic Common Technical Document (eCTD)
M9: Biopharmaceutics Classification System-based
Biowaivers
M10: Bioanalytical Method Validation
