CTD is common technical document for submission of dossier and widely accepted format for ease of submission and evaluation purpose.
TRS 961, Annex 15, Guidelines on submission of documentation for a multisource (generic) finished product. General format: preparation of product dossiers in common technical document format
Objectives of CTD guidelines
To significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals
To facilitate regulatory reviews and communication with the applicant by a standard document of common elements
To simplify the exchange of regulatory information between Regulatory Authorities
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
Qbd is a technique of planing a safeguard for the formulation from the process of starting material to the final product , its main aim is to built the quality in the product not to testing.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
Qbd is a technique of planing a safeguard for the formulation from the process of starting material to the final product , its main aim is to built the quality in the product not to testing.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
Module 1: Introduction to FDA and Quality System RegulationsQAConsulting
An introduction to FDA and Quality System Regulations wherein participants will gain an understanding of the history of the Food and Drug Administration as well as an overview of Quality System Regulations.
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
IMPLANTS
MEDICAL DEVICES
REGULATIONS IN INDIA
CLASSIFICATION OF MEDICAL DEVICES{CDSCO, FDA}
IMPLANTS
CLASSIFICATION OF IMPLANTS
IMPLANTABLE MEDICAL DEVICES
RISKS RELATED TO IMPLANTS
ADVANTAGES & DISADVANTAGES
Change control is a formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might effect a validated status. The intent is to determine the need for the action that would ensure that the system is maintained in a validated state.
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
Successfully Responding to FDA Inspections (483s) & Warning LettersMichael Swit
November 10, 2015 webinar sponsored by Compliance2Go reviewing key issues and tactics associated with dealing with a company's reply to an FDA inspection and related warning letters. Includes lessons from actual responses.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
Module 1: Introduction to FDA and Quality System RegulationsQAConsulting
An introduction to FDA and Quality System Regulations wherein participants will gain an understanding of the history of the Food and Drug Administration as well as an overview of Quality System Regulations.
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
IMPLANTS
MEDICAL DEVICES
REGULATIONS IN INDIA
CLASSIFICATION OF MEDICAL DEVICES{CDSCO, FDA}
IMPLANTS
CLASSIFICATION OF IMPLANTS
IMPLANTABLE MEDICAL DEVICES
RISKS RELATED TO IMPLANTS
ADVANTAGES & DISADVANTAGES
Change control is a formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might effect a validated status. The intent is to determine the need for the action that would ensure that the system is maintained in a validated state.
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
Successfully Responding to FDA Inspections (483s) & Warning LettersMichael Swit
November 10, 2015 webinar sponsored by Compliance2Go reviewing key issues and tactics associated with dealing with a company's reply to an FDA inspection and related warning letters. Includes lessons from actual responses.
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
common technical document vs electronic common technical document MayankGupta851
This presentation deals with brief overview of common technical document and its electronic version that is implemented by three ICH regions and common format for the dossier preparation for NDA application and documents required to prepare types of modules in database in specified format as specified by regulatory authorities.
common technical document and electronic document by akshay trivedi
The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The Common Technical Document is divided into five modules: Administrative and prescribing information
The Common Technical Document (CTD) was designed to provide a common format between Europe, USA, and Japan for the technical documen- tation included in an application for the registration of a human pharmaceutical product..
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
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
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
Title: Sense of Smell
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 primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
- 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
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.
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
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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
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
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.
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
3. ICH
• Harmonization of regulatory requirements was pioneered by the
EC, Europe, in the 1980s
• Formed in 1990 as International Conference on Harmonization with
agreement between regulatory agencies and industry associations
of Europe, Japan and the US- tripartite agreement
• Currently International Council for Harmonization of Technical
Requirements for Pharmaceuticals for Human Use.
• A legal entity under Swiss law from 23 October 2015 as an
international association
3
4. ICH
• Evolved to respond to increasingly global developments in the
pharmaceutical sector.
• ICH guidelines are applied by a growing number of regulatory
authorities
• ICH's mission is to achieve greater harmonization 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.
• Includes 19 Members and 35 Observers.
4
5. ICH Guidelines
ICH guidelines are divided into 4 categories
Q: Quality (14 guidelines)
S: safety (12 guidelines)
E: Efficacy (20 guidelines)
M: Multi disciplinary (14 guidelines)
5
6. Q Guidelines
Q1A- Q1F Stability
Q2 Analytical Validation
Q3A-Q3E Impurities
Q4A-Q4B Pharmacopeia
Q5A-Q5E Quality of Biotechnology Products
Q6A-Q6B Specifications
Q7 Good Manufacturing Practices
Q8 Pharmaceutical Development
Q9 Quality Risk Management
Q10 Pharmaceutical Quality System
Q11 Development and Manufacture of Drug Substances
Q12 Lifecycle Management
Q13 Continuous Manufacture of Drug Substance and Drug Products
Q14 Analytical Procedure Development
6
7. Basics of CTD
• CTD is common technical document for submission of dossier and widely
accepted format for ease of submission and evaluation purpose.
• TRS 961, Annex 15, Guidelines on submission of documentation for a
multisource (generic) finished product. General format: preparation of
product dossiers in common technical document format
• ASEAN has A-CTD format
• ICH M4 is the CTD guidelines
• May be submitted as printed format as CTD or electronic version as e-CTD
7
8. Basics of CTD
• CTD is not a global dossier.
• It is an internationally agreed format for the preparation of applications to
be submitted to regulatory authorities
• The CTD indicates an appropriate format for the data that have been
required in an application
• The CTD-format is applicable for all types of products (new chemical
entities, radiopharmaceuticals, vaccines, herbals etc.)
• Contains 5 modules. All modules are harmonized except module 1-
regional specific
8
9. Objectives of CTD guidelines
• To significantly reduce the time and resources needed to
compile applications for registration of human pharmaceuticals
• To facilitate regulatory reviews and communication with the
applicant by a standard document of common elements
• To simplify the exchange of regulatory information between
Regulatory Authorities
9
10. Overview
The CTD is organized into five
modules
Module 1 is region specific
Modules 2, 3, 4 and 5 are intended to
be common for all regions
In July 2003, the CTD became the
mandatory format for new drug
applications in the EU and Japan, and
the strongly recommended format of
choice for NDAs submitted to FDA,
United States
10
11. Module 1: Regional Administrative Information
Covers Administrative and Prescribing Information
1.1 Table of Contents of the Submission Including Module 1
1.2 Documents Specific to each Region
CTD - Module 1
12. CTD - Module 1: Regional Administrative
Information
1.0 Cover Letter
1.1 TOC
1.2 Application Information
1.3 Product information
1.4 Regional summaries
1.5 Electronic Review
1.6 Samples
1.2.1 EOI
1.2.2 MA
1.2.3 CEP and LOA
1.2.4 LOA
1.2.5 GMP Certificate
1.2.6 Biowaiver request
1.3.1 SMPC
1.3.2 Labelling
1.3.3. PIL
1.4.1 BTIF (Bioequivalence trial
information form)
1.4.2 QIS
13. Common Technical Document Summaries
2.1 Common Technical Document Table of Contents (Modules 2-5)
2.2 CTD Introduction
2.3 Quality Overall Summary
2.4 Nonclinical Overview
2.5 Clinical Overview
2.6 Nonclinical Written and Tabulated Summaries
2.7 Clinical Summary
CTD: Module 2
15. • A summary that follows the scope and outline of the body of data in Module 3
• Should not include information that was included in Module 3
• Emphasize and discuss critical key parameter of the product
• Discuss key issues to integrate information from Module 3 and other modules
• Typically, 40 pages, excluding tables and figures
CTD: Module 2.3 QOS
16. • 2.3 Introduction
• 2.3.S Drug Substance (2.3.S1- S.7)
• 2.3.P Drug Product (2.3.P.1-P.8)
• 2.3.A Appendices (2.3.A.1-A.3)
• 2.3.R Regional information
CTD: Module 2.3 QOS Format
17. CTD - Module
2.3: QOS Format
2.3 S 1-7
2.3 P 1-8
2.3 A
2.3 R 1-2
S.1 General information
S.2 Manufacture
S.3 Characterization
S.4 Control of the API
S.5 Reference Standard
S.6 Container Closure system
S.7 Stability
P.1 Description of Composition
P.2 Pharmaceutical
Development
P.3 Manufacture
P.4 Control of excipients
P.5 Control of FPP
P.6 Reference Standard
P.7 Container Closure system
P.8 Stability
A.1
A.2
2.3 S
2.3 A
2.3 P
18. Module 3 : Quality
3.1. Table of contents of module 3
3.2. Body of data
3.2.S Drug substance (name, manufacturer)
3.2.P Drug product (name, dosage form)
3.2.A Appendices
3.2.R Regional information
3.3 Literature references
CTD: Module 3
19. 3.2.S
3.2.S Drug substance (name, manufacturer)
3.2.S.1 General Information (name, manufacturer)
3.2.S.2 Manufacture (name, manufacturer)
3.2.S.3 Characterization (name, manufacturer)
3.2.S.4 Control of Drug Substance (name, manufacturer)
3.2.S.5 Reference Standards or Materials (name, manufacturer)
3.2.S.6 Container Closure System (name, manufacturer)
3.2.S.7 Stability (name, manufacturer)
CTD: Module 3
20. CTD - Module 3.2.S: Drug Substance
3.2.S.1 General information
3.2.S.2 Manufacturer
3.2.S.3 Characterization
3.2.S.4 Control of the API
3.2.S.5 Reference standard
3.2.S.6 Container closure system
3.2.S.7 Stability
3.1 TOC
3.2 Body of data
3.2 S (Drug substance)
3.2 P (Drug Product)
3.2 A (Appendix)
3.2 R (Regional information)
3.3 Literature reference
3.2 S
DMF/APIMF
21. 3.2.P
3.2.P DRUG PRODUCT (NAME, DOSAGE FORM)
3.2.P.1 Description and Composition of the Drug Product (name, dosage form)
3.2.P.2 Pharmaceutical Development (name, dosage form)
3.2.P.3 Manufacture (name, dosage form)
3.2.P.4 Control of Excipients (name, dosage form)
3.2.P.5 Control of Drug Product (name, dosage form)
3.2.P.6 Reference Standards or Materials (name, dosage form)
3.2.P.7 Container Closure System (name, dosage form)
3.2.P.8 Stability (name, dosage form)
3.2.A APPENDICES
3.2.R REGIONAL INFORMATION
CTD: Module 3.2.P: Drug Product
22. CTD - Module 3.2.P Drug
Product
3.2.P.1 Description of composition
3.2.P.2 Pharmaceutical development
3.2.P.3 Manufacturer
3.2.P.4 Control of excipients
3.2.P.5 Control of FPP
3.2.P.6 Reference standard
3.2.P.7 Container closure system
3.2.P.8 Stability
3.1 TOC
3.2 Body of data
3.2 S (Drug substance)
3.2 P (Drug Product)
3.2 A (Appendix)
3.2 R (Regional information)
3.3 Literature reference
3.2 P
23. CTD - Module 3.2.P Drug
Product
P.2.1 Components
P.2.2 FPP
P.2.3 Manufacturing Process Dev
P.2.4 Container Closure System
P.2.5 Microbiological attributes
P.2.6 Compatibility
3.2.P.1 Description of composition
3.2.P.2 Pharmaceutical development
3.2.P.3 Manufacturer
3.2.P.4 Control of excipients
3.2.P.5 Control of FPP
3.2.P.6 Reference standard
3.2.P.7 Container closure system
3.2.P.8 Stability
3.2 P
P.3.1 Manufacturer(s)
P.3.2 Batch formula
P.3.3 Description of mfg. process
P.3.4 Control of critical steps and
intermediate
P.3.5 Process validation and evaluation
P.4.1Specifications
P.4.2 Analytical procedure
P.4.3 Validation of analytical procedure
P.4.4 Justification of specification
P.4.5 Excipients of human or animal origin
P.4.6 Novel excipients
24. CTD - Module 3.2.P Drug
Product
3.2.P.1 Description of composition
3.2.P.2 Pharmaceutical development
3.2.P.3 Manufacturer
3.2.P.4 Control of excipients
3.2.P.5 Control of FPP
3.2.P.6 Reference standard
3.2.P.7 Container closure system
3.2.P.8 Stability
3.2 P
P.8.1Stability Summary and conclusion
P.8.2 Stability protocol and commitment
P.8.3 Stability data
P.5.1 Specification
P.5.2 Analytical procedure
P.5.3 Validation of analytical procedure
P.5.4 Batch analysis
P.5.5 Characterization of impurities
P.5.6 Justification of specifications
25. Module 4: Nonclinical study reports:
Not applicable for multisource products
4.1 Table of Contents of Module 4
4.2 Study Reports
Module 5: Clinical study reports
CTD: Module 4 and 5
Editor's Notes
Module 2 is a high level summary of the entire CTD document. 2.2 looks at a summary of the product. 2.3 gives a high level quality summary. 2.4 and 2.5 gives an overview of non clinical and clinical overview. The overview is basically all that was done but summaries presents results.