The document discusses various drug regulatory authorities around the world including the FDA, TGA, CDSCO, and ICMR. It provides an overview of the roles and responsibilities of these agencies in regulating drugs and pharmaceutical products to ensure public health and safety. Key functions of regulatory authorities that are described include evaluating new drugs, inspecting manufacturing facilities, monitoring adverse events, and establishing product standards.
This presentation is about the basic responsibilities and functions of CDSCO explaining the regulatory body's constitution, comprising of functions of state licensing authority and port offices covering the guidelines for new drug approval process, clinical trails and medical devices. this presentation also give a basic note on SUGAM
The government has notified the DPCO 2013 under the Essential Commodities Act, 1955, which will give power to the NPPA (National Pharmaceutical Pricing Authority (NPPA )to regulate prices of 348 essential drugs along with their specified strengths and dosages under NLEM 2011.
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.
This presentation is about the basic responsibilities and functions of CDSCO explaining the regulatory body's constitution, comprising of functions of state licensing authority and port offices covering the guidelines for new drug approval process, clinical trails and medical devices. this presentation also give a basic note on SUGAM
The government has notified the DPCO 2013 under the Essential Commodities Act, 1955, which will give power to the NPPA (National Pharmaceutical Pricing Authority (NPPA )to regulate prices of 348 essential drugs along with their specified strengths and dosages under NLEM 2011.
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.
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.
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
Introduction Central Drug Testing Laboratories & Responsibilities
Role of Central Drugs Testing Laboratory
No of laboratories in India, No of laboratories in each State
Presented by
J. Vinay Krishna
Department of Industrial Pharmacy
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
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.
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
Introduction Central Drug Testing Laboratories & Responsibilities
Role of Central Drugs Testing Laboratory
No of laboratories in India, No of laboratories in each State
Presented by
J. Vinay Krishna
Department of Industrial Pharmacy
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
Introduction to pharmaceutical regulatory agenciesDoaa Abouzeid
Regulatory authorities act as a guardian that ensures the safety, efficacy and quality of drugs available to the public.
They work to identify the strengths and weaknesses of drug regulation and to propose strategies to improve drug regulation.
The international regulatory organizations whether they are Governmental or Non-governmental play an essential role in all aspects of pharmaceutical regulations related to drug product registration, manufacturing, distribution, price control, marketing, research and development, and intellectual property protection.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
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.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
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
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?
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
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
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
1. Name: Sk. Shaik Banu
Reg.No.12P21R0050
Course: B.Pharmacy IV -I Sem
Guide:
Mr. Voleti.Vijaya Kumar M.Pharmacy.,
Assistant Professor,
Dep of Pharmaceutics,
RAO'S College of Pharmacy,
NELLORE
Principal :
Dr. P. Shanmuga Pandiyan M.Pharmacy.,
Ph.d.,
RAO’S College of Pharmacy,
NELLORE
4. Definitions
■Regulatory Affairs is a comparatively new profession which has
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
■Drug Regulatory Affairs is a function which regulates the
pharmaceutical science in order to facilitate trade / business in and
outside the country of origin for public interest
5. Introduction:
.
To protect consumer’s health
against harm resulting from
poor quality medicinal
products, drug regulatory
agencies have been developed
in many industrialized
countries of the world.
6. Functions of DRA’s
■Licensing, registration and labelling of new pharmaceutical
products.
■Inspection of manufacturing facilities and distribution
channels
■Training of health care professionals
■Arrangement of awareness programmes for general public
8. United states food and drugs
administration
.
•It is an agency of one of the United States federal Human Services.
•The main role of FDA is to protect and promote public health by
controlling and monitoring the manufacture, import, transport, vaccines,
cosmetics etc.
•It also evaluates the applications for new drugs, biologicals, medical
devices, food and infant formulae.
9. Offices of inspectorate Responsibilities
Office of the commissioner Centre for scientific activities, policy making and planning,
women’s and minority health initiatives, scientific activities.
Centre for biologics evaluation & research To provide information regarding safe and appropriate use of
biological therapeutic agents to common public.
Centre for devices & radiological health To provide accessible science-based information about the
products to the consumers
Centre for drug evaluation and research To regulate prescription as well as OTC drugs including
biological therapeutics and generic drugs like sunscreen
lotions etc.
Centre for tobacco products To establish and enforce advertising and promotion
restrictions pertaining to tobacco products.
Centre for veterinary medicines To review and evaluate the available data regarding safety
and efficacy of marketed animal drugs as well as animal drugs
under investigation.
Centre for food safety and applied nutrition It assures the safety & appropriate labeling of almost all the
food products except meat products in US
National centre for toxicological research To advance scientific approaches and tools.
Office of regulatory affairs investigators inspect the production and
warehousing facilities and investigate complaints,
10. Canadian Health Products and
Food Branch Inspectorate
■It helps canadians to maintain and improve their health whilst
respecting individual choices and circumstances, aims at listing
canada among the countries with the healthiest people in the
world.
■The primary function of HPFBI is to implement a national
compliance and enforcement program for the products that are
under the regulation of Health Canada.
11. The HPFBI has 10 responsibility offices which are
discussed below:
Offices of inspectorate Responsibilities
1 Director General’s office To liaise with other directorates, other
branch offices and the office of
Assistant Deputy Minister.
1 Inspectorate Ottawa Licensing activities
2 Laboratories To ensure support to inspection and
investigations
6 Regional Offices To conduct inspection and
investigations.
12. ■It was formed under the Therapeutic Goods Act 1989 to
regulate therapeutic goods including medicines, medical
devices, blood, tissues and blood products in Australia,
thereby protecting public health and safety.
■It also aims to make sure that the Australian community,
within a time frame has access to new therapeutic goods.
13. Organisation structure:
Offices Responsibilities
Market Authorization Group (MAG) To decide whether or not to approve the
therapeutic goods imported, exported,
manufactured and supplied in Australia.
Monitoring and Compliance
Group(MCG)
It monitors the therapeutic products
approved for the supply in Australia
Regulatory Support Group It provides regulatory support services
like legal, human resource management,
finance, information technology and
parliamentary management services.
14. Functions of TGA:
■Evaluation of the quality, safety and efficacy of prescription
drugs and other drugs like OTC medicines, alternative
medicines and medical devices.
■To control the export of drugs and medical devices from
Australia.
■To control drug and device advertisements.
■To monitor adverse drug reactions.
15. ■It is a drug regulatory organization of India.
■The vision of CDSCO is to protect and promote public health
in India and its mission is to safeguard and enhance public
health by assuring safety, efficacy and quality of drugs,
cosmetics and medical devices.
16.
17. Functions:
■Laying down the safety and quality standards for drugs,
cosmetics, diagnostics, and devices.
■Regulatory the marketing of new drugs.
■Publishing and updating the Indian Pharmacopoeia.
■Guiding on technical matters and monitoring adverse drug
reactions.
■Screening the drug formulations that are available in the
Indian market.
18. ■Indian Pharmaceutical Association (IPA) is the premier
professional association of pharmacists in India.
■The association has more than 10,000 members from various
parts of the country and it operates in India through 17 state
branches & more than 33 local branches
■The Indian Pharmaceutical Association (IPA) has demanded
to amend the Drugs &Cosmetics Act and Rules 1945 to make
only the pharmacy graduates eligible to become expert staffs in
the pharma manufacturing units
19. Drug Technical Advisory Board (DTAB)
■The Central Government constitute a Board (to be called the
Drugs Technical Advisory Board) to advise the Central
Government and the State Governments on technical matters
arising out of the administration of D&C, Act 1940
20. The Board shall consist of the following members:
10 ex-officio
members
5 Nominated
members
5 Elected
MembersDTAB
-20 members
21. Activities and responsibilities
■It advices matter related to drugs.
■The nominated and elected members of the Board shall hold
office for three years, but shall be eligible for re-nomination and
re-election.
■The Board may, subject to the previous approval of the central
Government, regulating its own procedure.
23. Responsibilities
■Development of comprehensive monographs.
■Accord priority to monographs of drugs included in the
national essential drug list and their dosage forms.
■Preparation of monographs for products that have normally
been in the market for not less than 2 years.
24. Indian council of Medical Research (ICMR)
■The Indian Council of Medical Research
(ICMR), New Delhi, the apex body in
India for the formulation, coordination and
promotion of biomedical research, is one
of the oldest medical research bodies in
the world.
26. Responsibilities
■Extramural research is promotes by ICMR by establishing
■Open ended research is conducted on the basis of applications
for grants in aid received from scientists in non-ICMR Research
institutes, Medical colleges and Universities located in different
parts of the country.
27. References
1. Hasumati Rahalkar, Historical Overview of Pharmaceutical Industry and Drug
Regulatory Affairs, Kurz, Pharmaceut Reg Affairs 2012, S11-002
http://www.slideshare.net/BeenaMaddi/international-regulatory-agencies
http://www.fda.gov/
http://www.hc-sc.gc.ca/index-eng.php
https://www.tga.gov.au/
6,8 http://www.slideshare.net/sampathramaswamy1/regulatory-aspects-17409779
7.http://www.ipapharma.org/
9. http://www.ipc.gov.in
10. http://www.icmr.nic.in