The document provides an overview of the International Conference on Harmonisation (ICH), which brings together regulatory authorities and pharmaceutical experts from Europe, Japan, and the United States to discuss scientific and technical aspects of drug registration. The ICH was established in 1990 to improve efficiency and make new drugs available more quickly by harmonizing technical requirements for registration. It covers topics related to quality, safety, efficacy, and multidisciplinary issues. The overview describes the ICH parties and objectives, and provides examples of guidelines developed within each of the four main categories.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
The presentation will give an insight into ICH Q1A Stability testing of New drug products. Here the ppt is much focused on stability requirements for ANDA, no: of batches, storage conditions, testing frequency.
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
The presentation will give an insight into ICH Q1A Stability testing of New drug products. Here the ppt is much focused on stability requirements for ANDA, no: of batches, storage conditions, testing frequency.
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
Key importance of ICH guideline, a brief summary on the international guidelines for new drug development.
Specifically for regulatory affairs student of MPharm
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
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 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.
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.
A Strategic Approach: GenAI in EducationPeter 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.
Executive Directors Chat Leveraging AI for Diversity, Equity, and InclusionTechSoup
Let’s explore the intersection of technology and equity in the final session of our DEI series. Discover how AI tools, like ChatGPT, can be used to support and enhance your nonprofit's DEI initiatives. Participants will gain insights into practical AI applications and get tips for leveraging technology to advance their DEI goals.
How to Add Chatter in the odoo 17 ERP ModuleCeline George
In Odoo, the chatter is like a chat tool that helps you work together on records. You can leave notes and track things, making it easier to talk with your team and partners. Inside chatter, all communication history, activity, and changes will be displayed.
Thinking of getting a dog? Be aware that breeds like Pit Bulls, Rottweilers, and German Shepherds can be loyal and dangerous. Proper training and socialization are crucial to preventing aggressive behaviors. Ensure safety by understanding their needs and always supervising interactions. Stay safe, and enjoy your furry friends!
A workshop hosted by the South African Journal of Science aimed at postgraduate students and early career researchers with little or no experience in writing and publishing journal articles.
A review of the growth of the Israel Genealogy Research Association Database Collection for the last 12 months. Our collection is now passed the 3 million mark and still growing. See which archives have contributed the most. See the different types of records we have, and which years have had records added. You can also see what we have for the future.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
This presentation includes basic of PCOS their pathology and treatment and also Ayurveda correlation of PCOS and Ayurvedic line of treatment mentioned in classics.
3. INTRODUCTION
The International Conference on
Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human
Use (ICH) is a unique 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 of product registration.
4. AIM
The International Conference on Harmonisation of Technical
Requirements for the Registration of Pharmaceuticals for
Human Use (ICH) was established in 1990 as a joint
regulatory/industry project to improve, through
harmonisation, the efficiency of the process for developing
and registering new medicinal products in Europe, Japan
and the United States, in order to make these products
available to patients with a minimum of delay.
The six parties to ICH represent the regulatory bodies and
research based industry in the three regions, Europe, Japan
and the USA, where the vast majority of new medicines are
currently developed.
5. ICH PARTIES
European Commission European Union (EU)
European Federation of Pharmaceutical Industries and
Associations (EFPIA)
Ministry of Health, Labour and Welfare, Japan (MHLW)
Japan Pharmaceutical Manufacturers Association (JPMA)
US Food and Drug Administration (FDA)
Pharmaceutical Research and Manufacturers of America
(PhRMA)
6. OBJECTIVES
More economical use of human, animal, and
material resources
Elimination of unnecessary delay in the
global development & availability of new
medicines.
Maintaining safeguards on Quality, safety,
efficacy and regulatory obligations to protect
public health.
7. TOPIC OF ICH
Four Broad Categories - QSEM
Quality (Q): those relating to chemical and pharmaceutical Quality
Assurance (Stability Testing, Impurity Testing, etc.)
Safety (S): those relating to in vitro and in vivo pre-clinical studies
(Carcinogenicity Testing, Genotoxicity Testing, etc.)
Efficacy (E): those relating to clinical studies in human subject (Dose
Response Studies, Good Clinical Practices, etc.)
Multidisciplinary (M): cross-cutting Topics which do not fit uniquely
into one of the above categories (MedDRA, ESTRI, M3, CTD, M5)
8. OVERVIEW OF ICH
1. QUALITY
Q1A (R2): STABILITY TESTING OF NEW DRUGS
AND PRODUCTS
QIB: PHOTOSTABILITY TESTING
Q1C: STABILITY TESTING OF NEW DOSAGE
FORMS
Q1D: BRACKETING AND MATRIXING DESIGNS
FOR STABILITY TESTING OF DRUG
SUBSTANCES AND DRUG PRODUCTS.
9. Q1E: EVALUATION OF STABILITY DATA
QIF: STABILITY DATA PACKAGE FOR
REGISTRATION IN CLIMATIC ZONES III AND IV
Q2A: DEFINITIONS AND TERMINOLOGY:
ANALYTICAL VALIDATION
Q2B: METHODOLOGY
03A(R2) IMPURITIES IN NEW DRUG
SUBSTANCES
03B(R2): IMPURITIES IN NEW DRUG PRODUCT
03C(R3) IMPURITIES GUIDELINES FOR
RESIDUAL SOLVENTS
11. Q6A: SPECIFICATIONS, TEST PROCEDURES AND
ACCEPTANCE CRITERIA FOR NEW DRUG
SUBSTANCES AND PRODUCTS
Q6B : SPECIFICATIONS TEST PROCEDURES AND
ACCEPTANCE CRITERIA FOR
BIOTECHNOLOGICAL/ BIOLOGICAL PRODUCTS
Q7A: GMP FOR ACTIVE PHARMACEUTICAL
INGREDIENTS
Q8: PHARMACEUTICAL DEVELOPMENT
Q9: QUALITY RISK MANAGEMENT
Q10: PHARMACEUTICAL QUALITY SYSTEM
12. 2. SAFETY
SIA: GUIDELINE ON THE NEED FOR
CARCINOGENICITY STUDIES OF PHARMACEUTICALS
S1B: TESTING FOR CARCINOGENICITY OF
PHARMACEUTICALS
SIC(R2): DOSE SELECTION FOR CARCINOGENICITY
STUDIES OF PHARMACEUTICALS
S2(R1): GUIDANCE ON GENOTOXICITY TESTING AND
DATA INTERPRETATION FOR PHARMACEUTICALS
INTENDED FOR HUMAN USE
13. S3A: NOTE FOR GUIDANCE ON
TOXICOKINETICS: THE ASSESSMENT OF
SYSTEMIC EXPOSURE IN TOXICITY
STUDIES
S3B: PHARMACOKINETICS:GUIDANCE
FOR REPEATED DOSE TISSUE
DISTRIBUTION STUDIES
S4: DURATION OF CHRONIC TOXICITY
TESTING IN ANIMALS (RODENT AND NON
RODENT TOXICITY TESTING)
14. S5(R2): DETECTION OF TOXICITY TO
REPRODUCTION FOR MEDICINAL
PRODUCTS & TOXICITY TO MALE
FERTILITY
S6(R1): ADDENDUM TO ICH S6:
PRECLINICAL SAFETY EVALUATION OF
BIOTECHNOLOGY-DERIVED
PHARMACEUTICALS
S6: PRECLINICAL SAFETY EVALUATION
OF BIOTECHNOLOGY DERIVED
PHARMACEUTICALS
15. S7A SAFETY PHARMACOLOGY STUDIES
FOR HUMAN PHARMACEUTICALS
S7B: THE NON-CLINICAL EVALUATION OF
THE POTENTIAL FOR DELAYED
VENTRICULAR REPOLARIZATION (QT
INTERVAL PROLONGATION) BY HUMAN
PHARMACEUTICALS
S8: IMMUNOTOXICITY STUDIES FOR
HUMAN PHARMACEUTICALS
S9: NONCLINICAL EVALUATION FOR
ANTICANCER PHARMACEUTICALS
16. 3. EFFICACY
E1: THE EXTENT OF POPULATION EXPOSURE TO ASSESS
CLINICAL SAFETY
E2A: CLINICAL SAFETY DATA MANAGEMENT
E2B(R2): MAINTENANCE OF THE ICH GUIDELINE ON CLINICAL
SAFETY DATA MANAGEMENT
E2B(R3): REVISION OF THE ICH GUIDELINE ON CLINICAL
SAFETY DATA MANAGEMENT & DATA ELEMENTS FOR
TRANSMISSION OF INDIVIDUAL CASE SAFETY REPORTS
E2C(R1): CLINICAL SAFETY DATA MANAGEMENT: PERIODIC
SAFETY UPDATE REPORTS FOR MARKETED DRUGS
E2D: POST-APPROVAL SAFETY DATA MANAGEMENT:
DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING
17. E2E: PHARMACOVIGILANCE PLANNING
E2F: DEVELOPMENT SAFETY UPDATE REPORT
E3: STRUCTURE AND CONTENT OF CLINICAL
STUDY REPORTS
E4: DOSE-RESPONSE INFORMATION TO SUPPORT
DRUG REGISTRATION
E5(R1): ETHNIC FACTORS IN THE ACCEPTABILITY
OF FOREIGN CLINICAL DATA
E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE
E7: STUDIES IN SUPPORT OF SPECIAL
POPULATIONS:GERIATRICS
18. E8: GENERAL CONSIDERATIONS FOR CLINICAL TRIALS
E9: STATISTICAL PRINCIPLES FOR CLINICAL TRIALS
E10: CHOICE OF CONTROL GROUP AND RELATED ISSUES IN
CLINICAL TRIALS
E11: CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE
PEDIATRIC POPULATION
E12: PRINCIPLES FOR CLINICAL EVALUATION OF NEW
ANTIHYPERTENSIVE DRUGS
E14: THE CLINICAL EVALUATION OF QT/QTC INTERVAL
PROLONGATION AND PROARRHYTHMIC POTENTIAL FOR NON-
ANTIARRHYTHMIC DRUGS
E15: DEFINITIONS FOR GENOMIC BIOMARKERS,
PHARMACOGENOMICS PHARMACOGENETICS, GENOMIC DATA AND
SAMPLE CODING CATEGORIES
E16: GENOMIC BIOMARKERS RELATED TO DRUG RESPONSE:
19. 4. MULTIDISCIPLINARY
M1- MedDRA: Medical Terminology
M2-ESTRI: Electronic Standards for the Transfer of Regulatory
Information
M3- (R2): Nonclinical Safety Studies for the Conduct of Human
Clinical Trials and Marketing Authorization for Pharmaceuticals
M4-CTD: The Common Technical Document
M5 Data Elements and Standards for Drug Dictionaries