To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.
With respect to such products, protect the public health by ensuring that the food are safe, Wholesome, sanitary, and properly labelled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labelled, and public health and safety are protected from the electronic product radiation.
Participates through appropriate process with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
Regulatory affairs in Pharmaceutical IndustryRama Shukla
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
The NDA application is the vehicle through which drug sponsors, such as biotech and pharmaceutical companies, formally propose that the FDA approve a new pharmaceutical for sale and marketing
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
Regulatory affairs in Pharmaceutical IndustryRama Shukla
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.
This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): a standard for the design , conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
ICH-GCP is an International Conference on Harmonization Good Clinical Practice.
The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs.
These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
Introduction to Pharma regulatory affairsGIBT India
It constitutes of basic introduction of regulatory affairs in pharmaceuticals, career in pharma regulatory affairs, job opportunities and future aspect. GIBTIndia offers job oriented e- learning courses. Kindly visit us at www.gibtindia.com
Firstly it was a division of Chemistry, then named as The Bureau Of Chemistry.
In Jully1930,the name was shortened to Food And Drug Administration.
Up to 1940,FDA was under Department Of Agriculture.
In 1968,it become part of Public Health Service within Health Education And Welfare (HEW).
WHO AND PHARMACOVIGILANCE (Clinical Research & Pharmacovigilance.pptxDureshahwar khan
This presentation includes introduction to WHO International Drug Monitoring Program & its functions, Role of WHO in PV, Vigibase, regulatory terminology of ADR and evaluation of medication safety.
Pharmacovigilance Interview Question Part 1ClinosolIndia
"Pharmacovigilance Interview Question Part 1." In this insightful presentation, we delve into the crucial world of pharmacovigilance, exploring fundamental concepts and key questions that play a pivotal role in ensuring drug safety and healthcare integrity.
Embarking on a journey into the intricate realm of drug safety, 'Exploring the Foundations of Pharmacovigilance: Part 1' lays the groundwork for a comprehensive understanding of this crucial field. This segment serves as a gateway to the fundamental principles that underpin pharmacovigilance, unraveling the intricacies of adverse drug reaction monitoring and reporting. Delving into the significance of pharmacovigilance in ensuring patient safety, the exploration encompasses the key concepts and processes that form the backbone of drug safety surveillance. From identifying adverse events to understanding the roles of healthcare professionals and regulatory bodies, 'Part 1' provides a solid foundation for both novices and seasoned professionals alike. As we navigate through this informative chapter, the importance of robust pharmacovigilance practices in the ever-evolving landscape of healthcare becomes increasingly evident, setting the stage for the advanced concepts and global perspectives to follow in subsequent parts of this insightful series.
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
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.
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
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Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
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.
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
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
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
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
1. REGULATORY AUTHORITIES
US-FDA, WHO & ICH
1
Mr. Sagar Kishor Savale
[Department of Pharmaceutics]
avengersagar16@gmail.com
2015-2016
Department of Pharmacy (Pharmaceutics) | Sagar savale
2. CONTENTS:
1. Regulatory authorities
2. US FDA
i. Introduction
ii. Organization
iii. Mission
iv. What US FDA regulates?
v. What US FDA does not regulates?
vi. US FDA Guidelines
3. WHO
i. Introduction
ii. History
iii. Its peoples & Offices
iv. Governance of WHO
v. Functions
2
3. 3
4. ICH
i. Introduction
ii. Purpose
iii. ICH Members
iv. Structure
v. ICH guideline Topics
vi. ICH Quality Guidelines
Continue…
4. Country/Continent Regulatory Authorities
International • ICH
• WHO
• WTO
Europe • EMEA ( European Medicine Evaluation Agency )
India • CDSCO ( Central Drug Standard Control Organization)
US
• USFDA
• DHHS (Department Of Health & Human Services)
• NCCAM (National Center For Complementary & Alternative Medicine)
UK • MHRA (Medicines & Healthcare Products Regulatory
Authority )
Australia • TGA ( Therapeutic Goods Administration )
China • SFDA (State Food & Drug Administration)
Brazil • National Health Servillance Agency (NHSA)
Newzealand • Medsafe ( Medicines & Medical Devices Safety Authority )
Regulatory authorities
4
6. INTRODUCTION1,4
US FDA - An agency within the U.S. Public Health
Service, which is a part of the Department of Health
and Human Services.
Agency monitors the manufacture, import, transport,
storage and sale of Medicines, medical devices,
biological products & radiation-emitting devices.
6
7. ORGANISATION (BRANCHES)1,4,7
Centre for Biologics Evaluation and Research ( CBER )
Centre for Devices and Radiological Health ( CDRH )
Centre for Drug Evaluation and Research ( CDER )
Centre for Food Safety and Applied Nutrition ( CFSAN )
Centre for veterinary Medicine ( CVM )
Office of Regulatory Affairs ( ORA )
National Centre for Toxicological Research ( NCTR )
Office of Chief Council ( OCC )
Office of Commissioner ( OC )
7
8. MISSION1,4
To promote the public health by promptly and efficiently reviewing
clinical research and taking appropriate action on the marketing of
regulated products in a timely manner.
With respect to such products, protect the public health by ensuring
that the food are safe, Wholesome, sanitary, and properly labelled;
human and veterinary drugs are safe and effective; there is
reasonable assurance of the safety and effectiveness of devices
intended for human use; cosmetics are safe and properly labelled,
and public health and safety are protected from the electronic product
radiation.
Participates through appropriate process with representatives of
other countries to reduce the burden of regulation, harmonize
regulatory requirements, and achieve appropriate reciprocal
arrangements. 8
9. WHAT USFDA REGULATES?1,4
• Biological products
• Product manufacturing establishment Licensing
• Nations blood supply
• Research to establish product standards and to
develop improved testing methods
• Cosmetics
• Labelling
• Drugs
• Product approvals
9
10. • OTC and prescription drug labelling
• Drug manufacturing standards
• Foods
• Safety of all food products ( except meat and poultry)
• Radiation-Emitting Electronic Products
• Radiation safety performance standard for
microwave, ovens,diagnostic x-rays equipment,
cabinet x-ray system ( such as baggage x-rays at
airports ),Laser products,mercury vapour lamps
• Veterinary products.
Continue….
10
11. 11
WHAT USFDA DOES NOT REGULATES?
Advertisements
Alcohol
Consumer products
Drugs of abuse
Health insurance
Meat & poultry
Pesticides
Restaurants
12. 12
Part of title 21CFR Guidelines
Part of 58 Good laboratory practice for nonclinical
laboratory studies
Part of 101 Food labeling
Part of 110 Current good manufacturing practice in
manufacturing, packing, or holding human
food
Part of 201 Labeling
Part of 312 Investigational new drug application
Part of 314 Applications for FDA approval to market a
new drug
Part of 328 Over-the-counter drug products intended
for oral ingestion that contain alcohol
US-FDA GUIDELINES4,8
13. 13
Part of title 21CFR Guidelines
Part of 331 Antacid products for over-the-counter (otc)
human use
Part of 341 Cold, cough, allergy, bronchodilator, and
antiasthmatic drug products for over-the-
counter human use
Part of 600 Biological products: general
Part of 820 Quality system regulation
Part of 892 Radiology devices
Part of 1392 Registration of manufacturers, distributors,
importers and exporters of list
Continue…
15. INTRODUCTION1,5
WHO is the United Nations specialised agency for
health.
WHO is the directing and coordinating authority
for health within the world. It is responsible for
providing leadership on global health matters,
shaping the health research agenda, setting
norms and standards, articulating evidence-based
policy options, providing technical support to
countries and monitoring and assessing health
trends.
15
16. HISTORY1,5
When diplomats met to form the United Nations in 1945, one of
the thing they discussed was setting up a global health
organization.
WHO’s Constitution came into exist on 7 April 1948 – a date we
now celebrate every year as World Health Day.
Objective of WHO1,5
Attainment of the highest possible level of Health by all
peoples.
16
17. ITS PEOPLE AND OFFICES1,5
The headquarter is at Geneva,Switzerland.
six regional offices are :
1. Regional Office for South-East Asia:
- at New Delhi
2. Regional Office for Africa:
- at Congo
3. Regional Office for the America:
- at Washington, USA
4. Regional Office for Europe:
- at Copenhagen,Denmark
5. Regional Office for the Eastern Mediterranean:
- at Cairo, Egypt
6. Regional Office for the Western Pacific:
- at Manila,Philippines 17
18. GOVERNANCE OF WHO1,5
• The World health Assembly is the supreme decision-making
body for WHO. It meets each year in May at Geneva & is
attended by delegations from all 193 Member countries.
• The world health assembly is headed by the Director-
General who is nominated by the executive board. The
executive board is composed of 32 members technically
qualified in the field of health.
• Members are elected for three-year terms. The main Board
meeting is held in January, with a second shorter meeting in
May of each year, immediately after the Health Assembly, for
more administrative matters.
• Function: To approve the WHO programme & the budget for
same & to decide major policy questions.
18
19. Functions of WHO1,2,5
1.To act as the directing & co-ordinating authority on
international health work.
2.To assist governments,upon request,in strengthening
health services.
3.To furnish appropriate technical assistance & in
emergencies, necessary aid upon the request of
governance.
4.To stimulate & advance work to eradicate epidemic,
endemic & other diseases.
5.To promote & conduct research in the field of Health.
19
20. 20
6. To establish & revise as necessary international
nomenclature of diseases,of causes of death & public
health practices.
7. To develop, establish & promote internation standards of
food,biological,pharmaceutical products.
8. To provide information ,counsel & assistance in the field
of Health.
9. To promote improved standards of teaching & training in
the Health,medical & related professions.
10.To establish & maintain effective co-operation with the
United Nations,specializedagencies,governmental health
administration & professional groups.
Continue…
22. Introduction of ICH1,3,6
ICH - International Conference on Harmonization
of Technical Requirements for Registration of
Pharmaceuticals for Human Use.
It is a unique project that brings together the
regulatory authorities & experts from the
pharmaceutical industries in the Europe,Japan &
United states to discuss scientific and technical
aspects of the product registration.
22
23. PURPOSE1
To reduce the need to duplicate the testing carried
out during the research & development of new
medicines & thereby eliminate the unneccessary
delay in the availability of new medicines.
LOCATION3
ICH secretariat is based at Geneva.
23
24. Members of ICH1,3
ICH is comprised of six parties that represent the regulatory
bodies and research based industries in the European
Union,Japan and the USA.
JAPAN
- Ministry of Health,Labour and Welfare ( MHLW )
- Japan Pharmaceutical Manufacturers Associations ( JPMA )
Europe
- European Union ( EU )
- European federation of Pharmaceutical Industries and
Associations ( EFPIA )
USA
- Food and Drug Administration ( FDA )
- Pharmaceutical Research and Manufacturers of
America ( PhRMA )
24
26. Structure1,3
ICH Steering Committee,
ICH Coordinators,
ICH Secretariat &
ICH Working Groups.
- Expert Working Group (EWG),
- Implementation Working Group (IWG).
26
27. Q1A Stability Testing of New Drug Substances & Products
Q1B
Stability Testing : Photostability Testing of New Drug Substances
& Products
Q1C Stability Testing for New Dosage Forms
Q1D
Bracketing and Matrixing Designs for Stability Testing of New
Drug Substances and Products
Q1E Evaluation for stability data
Q1F
Stability Data Package for Registration Applications in Climatic
Zones III and IV
Q2
Validation of Analytical Procedures:
Text and Methodology 27
ICH GUIDELINES (Q)6
28. Q3A Impurities in new drug substances
Q3B Impurities in new drug products
Q3C Impurities: guideline for residual solvents
Q4B Evaluation and recommendation of pharmacopoeial texts for use
in the ICH regions
Q5A Viral safety evaluation of biotechnology products derived from
cell lines of human or animal origin
Q5B Quality of biotechnological products: analysis of the expression
construct in cells used for production of r-dna derived protein
products
Q5C Quality of biotechnological products:
Stability testing of biotechnological/biological products
Q5D Derivation and characterisation of cell substrates
Used for production of Biotechnological/biological products
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29. Q5E Comparability of biotechnological/biological products subject to changes in
their manufacturing process
Q6A Specifications: test procedures and acceptance criteria for new drug
substances and new drug products: chemical substances
Q6B Specifications: test procedures and acceptance criteria for
biotechnological/biological products
Q7 Good manufacturing practice guide for active pharmaceutical ingredients
Q8 Pharmaceutical development
Q9 Quality risk management
Q10 Pharmaceutical quality system
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30. CONCLUSION:
The Regulatory system for complementary
medicines must continue to ensure that the medicines
having highest possible level of confidence in their
overall safety and quality.
The current system of regulation of complementary
medicines allows consumers to have faith in the
quality, safety and efficacy of medicines.
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