Regulatory affairs is a profession that has developed to ensure the safety and efficacy of regulated products like pharmaceuticals, medical devices, and cosmetics. Regulatory affairs professionals are responsible for understanding and complying with regulations, collecting scientific data, and submitting applications to regulatory agencies to obtain approval to market products. They provide strategic guidance to companies on navigating the regulatory process from product development through marketing approval and post-market compliance. Ensuring compliance with regulations governing manufacturing, quality management systems, advertising, and other areas is important for regulatory affairs.
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.
Fundamental concept of regulatory affairs in pharmaceutical & biotechnologyHitendra Singh
RA is a comparatively new profession which developed from the desire of governments to protect public health by controlling the Quality, safety and efficacy of products in areas including pharmaceuticals, Biotechnology, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Goals of Regulatory Affairs Professionals:-
Protection of human health
Ensuring safety, efficacy and quality of drugs
Ensuring appropriateness and accuracy of product information
The dossier is a collection of documents that contain all the technical data of pharmaceutical products to be approved\ registered\ marketed in a country.
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.
Fundamental concept of regulatory affairs in pharmaceutical & biotechnologyHitendra Singh
RA is a comparatively new profession which developed from the desire of governments to protect public health by controlling the Quality, safety and efficacy of products in areas including pharmaceuticals, Biotechnology, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Goals of Regulatory Affairs Professionals:-
Protection of human health
Ensuring safety, efficacy and quality of drugs
Ensuring appropriateness and accuracy of product information
The dossier is a collection of documents that contain all the technical data of pharmaceutical products to be approved\ registered\ marketed in a country.
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
Drug Regulatory Affairs By Mr. Pankaj DhapadePankaj Dhapade
This presentation covers basic understandings of regulatory affairs profession. It contains,
1. Introduction of Regulatory Affairs
2. Why Drug Regulatory Affairs
3. Role of Regulatory Affairs Experts
4. Qualities of Regulatory Affairs Expert
5. Qualities for Submission Management
6. Regulatory Bodies
Disclaimer:
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
I am very much thankful to the original authors also, don't think I am just doing plagarism.
Hi, everyone i am providing you the best presentation about the Pakistan relate Drug regulatory affairs and the concept of regulatory affairs of Pharmaceuticals
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
The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia.he TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner.
Clinical evaluation and the latest 2016 guidelineGRCTS
This “General Guidance” document promotes a common approach to clinical evaluation for "medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices. The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question.
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
Drug Regulatory Affairs By Mr. Pankaj DhapadePankaj Dhapade
This presentation covers basic understandings of regulatory affairs profession. It contains,
1. Introduction of Regulatory Affairs
2. Why Drug Regulatory Affairs
3. Role of Regulatory Affairs Experts
4. Qualities of Regulatory Affairs Expert
5. Qualities for Submission Management
6. Regulatory Bodies
Disclaimer:
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
I am very much thankful to the original authors also, don't think I am just doing plagarism.
Hi, everyone i am providing you the best presentation about the Pakistan relate Drug regulatory affairs and the concept of regulatory affairs of Pharmaceuticals
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
The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia.he TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner.
Clinical evaluation and the latest 2016 guidelineGRCTS
This “General Guidance” document promotes a common approach to clinical evaluation for "medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices. The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question.
This presentation covers the manufacture and testing of all sterile drug products, including drugs that are sterilized by filtration or other means and aseptically processed, and drug products that are terminally sterilized. The type of products covered include sterile bulk drugs, ophthalmic drugs, otic dosage forms, small volume parenteral (SVS) products for small molecule and licensed biological
therapeutic drug products, large volume parenteral (LVP) products, and any other drug products required to be sterile or labeled as sterile. Center for Biologics Evaluation and Research (CBER) regulated products and veterinary drug products are excluded from coverage under this program.
The guidance information is tailored to sterile manufacturing operations and should be used in conjunction with the Compliance Program for Drug Manufacturing Inspections (CP 7356.002).
Medical Device Single Audit Program (MDSAP)EMMAIntl
In 2012, the International Medical Device Regulators Forum (IMDRF) developed the Medical Device Single Audit Program (MDSAP) to implement a harmonized and a global approach to audit medical device manufacturers. The program allows for MDSAP recognized organizations to conduct a single audit that satisfies the regulatory requirements of the countries participating in the program
A primary mission of the Food and Drug Administration is to conduct comprehensive regulatory coverage of all aspects of production and distribution of drugs and drug products to assure that such products meet the 501(a)(2)(B) requirements of the Act. FDA has developed two basic strategies:
. 1) evaluating through factory inspections, including the collection and analysis of associated samples, the conditions and practices under which drugs and drug products are manufactured, packed, tested and held, and
. 2) monitoring the quality of drugs and drug products through surveillance activities such as sampling and analyzing products in distribution.
FDA compliance program “ Drug Manufacturing Inpsections” (7356.002) is designed to provide guidance for implementing the first strategy. Products from production and distribution facilities covered under this program are consistently of acceptable quality if the firm is operating in a state of control.
The inspectional guidance in this program is structured to provide for efficient use of resources devoted to routine surveillance coverage, recognizing that in-depth coverage of all systems and all processes is not feasible for all firms on a biennial basis. It also provides for follow-up compliance coverage as needed.
“Drug Regulations” has prepared a summary from the compliance programme and is given below in the presentation.
Manufacturing Investigational Medicinal Products - Legislative and GMP requir...TGA Australia
Presentation on Legislative requirements, specific risks for IMP manufacturing, manufacturing authorisations, PIC/S Guide to GMP PE009-13 and common issues
The TGA Pharmacovigilance Inspection Pilot Program: 2015-2016TGA Australia
Firsthand overview of the TGA's Pharmacovigilance Inspection programme from the perspective of both the TGA and companies that have participated in the 'Pilot Inspection Programme'.
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
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.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
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
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.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
2. REGULATORY AFFAIRS :
Regulatory affairs is a comparatively
new profession which 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.
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4. REGULATORY AFFAIRS :
Regulatory affairs (RA), is a profession within
regulated industries. Regulatory affairs also has a
very specific meaning within the healthcare
industries.
The companies responsible for the discovery,
testing, manufacture and marketing of these
products also want to ensure that they supply
products that are safe and make a worthwhile
contribution to public health and welfare.
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5. REGULATORY AFFAIRS :
Regulatory Affairs ensure the Quality and Saftey
S
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6. REGULATORY AFFAIRS :
Regulatory Affairs Professionals Responsibility
The regulatory professional’s job is to keep track of
the ever-changing legislation in all the regions in
which the company wishes to distribute its products.
They also advise on the legal and scientific restraints
and requirements, and collect, collate and evaluate
the scientific data their research and development
colleagues are generating.
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7. REGULATORY AFFAIRS :
Regulatory Affairs manage the Scientific Data :
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8. REGULATORY AFFAIRS :
Regulatory Affairs manage the Scientific Data :
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9. REGULATORY AFFAIRS :
Regulatory Affairs Professionals Responsibility :
They are responsible for the presentation of registration
documents to regulatory agencies, and carry out all the
subsequent negotiations necessary to obtain and
maintain marketing authorization for the products
concerned.
They give strategic and technical advice at the highest
level in their companies, right from the beginning of the
development of a product, making an important
contribution both commercially and scientifically to the
success of a development programme and the company
as a whole.
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11. REGULATORY AFFAIRS :
Regulatory Affairs is a legal adviser :
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12. REGULATORY AFFAIRS :
Healthcare Regulatory Affairs (RA) :
The regulatory function in healthcare industries is vital in making
safe and effective healthcare products available worldwide.
Individuals who ensure regulatory compliance and prepare
submissions, as well as those whose main job function is clinical
affairs or quality assurance are all considered regulatory
professionals.
Regulatory professionals are employed in industry, government
and academia and are involved with a wide range of products,
including:
pharmaceuticals
medical devices
in vitro diagnostics
biologics and biotechnology
nutritional products
cosmetics
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14. REGULATORY AFFAIRS :
Regulatory Landscape and Product development
(R&D) :
The regulatory strategy and the development plan are evolving
documents. They should be reviewed and updated on a regular basis
during the product development process.
Step 1:
Properly classify your healthcare product
(i.e., as a drug, a biologic, a medical device or
a combination product) so that you know which regulatory path to take. If in
doubt, contact the appropriate regulatory body to confirm the product type and
how your product is regulated.
Step 2
Identify the claim of your healthcare product so that you know what types of
studies to conduct to support the claim and your product label. For instance,
changing your claim.
May change the medical device classification which can lead to different
regulatory oversight .
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15. REGULATORY AFFAIRS :
Regulatory Landscape and Product development
(R&D) :
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16. REGULATORY AFFAIRS :
Regulatory Landscape and Product development
(R&D) :
Step 3:
Determine your healthcare market. This will guide you to the
requirements that are specific to each jurisdiction. It is important to
identify jurisdiction-specific requirements upfront.
so that they can be included early in the product development plan.
Step 4:
Develop your regulatory strategy by identifying the specific regulatory
requirements as well as the possible pathway(s) to take. A thorough
understanding of these requirements will guide the development of your
regulatory strategy.
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17. REGULATORY AFFAIRS :
Regulatory Landscape and Product development
(R&D) :
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18. REGULATORY AFFAIRS :
Regulatory Landscape and Product development :
Step 5:
Establish a healthcare product development plan.
so that the product requirements can be translated into action i.e., who
does what and by when and for how much. Such plan should be
established collaboratively with input from different functional groups. It
should include key milestones, critical paths and periodic reviews for “go
and no-go” decisions and be updated periodically.
Step 6:
Execute the product development plan It is subject-matter experts who
possess knowledge of the investigational product who must carry out
(and be responsible for) the corresponding manufacturing, quality,
regulatory, non-clinical and clinical programs, as well as any
coordination with third parties
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19. REGULATORY AFFAIRS :
Regulatory Landscape and Product development :
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20. REGULATORY AFFAIRS :
Regulatory Landscape and Product development
(R&D) :
Step 7:
Execute the clinical plan
. If a clinical program is required in support of the licensing
application, these studies should be conducted according to good
clinical practices (GCP) and country-specific requirements, such as
ethics approvals and/or necessary regulatory approvals or conducting
the clinical trial(s). Often, it helps to have a pre-submission meeting
with the regulatory agency prior to submitting a clinical trial application
in order to address specific
Step 8:
Collect your data for regulatory submission .Once the data from the
product design and the manufacturing, quality, non-clinical and clinical
programs are available, these data and reports should be collected for
inclusion in the regulatory submission.
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21. REGULATORY AFFAIRS :
Regulatory Landscape and Product development
(R&D) :
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22. REGULATORY AFFAIRS :
Regulatory Landscape and Product development
(R&D) :
Step 9:
Collate your regulatory submission according to applicable regulatory
requirements specific to your type of submission. Ensure the
completeness of the submission and anticipate the resources needed to
address questions from the agency during the submission review. For
an innovative healthcare product, it is often recommended to have a
pre-submission meeting with your agency prior to submitting the
licensing application.
Step 10:
Ensure post-marketing compliance.
Make sure to fulfill all necessary post-marketing obligations.
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23. REGULATORY AFFAIRS :
Quality Management System and Regulatory Compliance Management :
A quality management system (QMS) is a collection of business processes focused on
achieving quality policy and quality objectives to meet customer requirements. It is
expressed as the organizational structure, policies, procedures, processes and
resources needed to implement quality management as per regulatory requirement.
Electronic document management
SOP management
Regulatory submission management
eCTD management
CAPA management
Change control
Deviation management
Complaints management
Audit management
Learning management and training
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24. REGULATORY AFFAIRS :
Quality Management System and Regulatory
Compliance Management :
.
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25. REGULATORY AFFAIRS :
Manufacturing and Regulatory Compliance :
Manufacturing compliance comprises the technical, legal and
corporate requirements, regulations and practices manufacturers
must comply with in order to produce and market products. The
risk of non-compliance has become an increasingly major
concern in recent years, particularly for manufacturers with
operations in multiple countries and jurisdictions. This
development has been further heightened by the increasing role
of governmental regulatory bodies in industry sectors, along with
the emergence of global standards to address the increasingly
global nature of manufacturing.
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27. REGULATORY AFFAIRS :
Manufacturing and Regulatory Compliance :
The core mandate guiding FDA regulatory oversight is consumer safety.
As a result, the FDA has defined Good Manufacturing Practices (GMP)
for both device and drug manufacturers that dictate the necessary
measures that must be taken to ensure that quality systems and
processes are in place to consistently produce safe, quality products.
Therefore, manufacturers in these sectors seek a manufacturing
certificate of compliance indicating that they meet GMP.
Meeting the challenge of manufacturing regulatory compliance requires
establishing a consistent top-down strategy for ensuring compliance
across the enterprise. Software developers have responded to this need
by creating solutions for managing regulatory compliance within
manufacturing execution systems (MES).
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29. REGULATORY AFFAIRS :
Manufacturing and Regulatory Compliance :
For those in manufacturing sectors regulated by the FDA, these
solutions must be compliant with Title 21 CFR Part 11 and Part 820.
Part 11 requires pharmaceutical manufacturers, medical device
manufacturers, biotech companies, biologics developers, contact
research organizations, and other FDA-regulated industries (with some
specific exceptions) to implement controls. These controls include
audits, system validations, audit trails, electronic signatures, and
documentation for software and systems involved in processing
electronic data that are (a) required to be maintained by the FDA
predicate rules or (b) used to demonstrate compliance to a predicate
rule.
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31. REGULATORY AFFAIRS :
Marketing and advertising
In most product areas where regulatory requirements
are imposed, restrictions are also placed upon the
claims which can be made for the product on labeling
or in advertising.
The regulatory affairs will take part in the
development of the product marketing concepts and
is usually required to approve packaging and
advertising before it is used commercially.
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35. REGULATORY AFFAIRS :
Regulatory submission processes:
Before a new drug or biologic can go to market, a
submission must be compiled and filed with all relevant regulatory
agencies to seek a review and, ultimately, regulatory approval.
1- Review and approval procedures :
a) Pre-submission meeting
b) Pre-submission activities
c) Administrative review
d) Agency review and sponsor response
e) Activities prior to the agency’s decision
f) Decision
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36. REGULATORY AFFAIRS :
Unlicensed and licensed products:
Advertising and promotion
Unlicensed healthcare products:
No advertising or promotion allowed Internationally, regulations exist prohibit the
advertising or promotion of unlicensed health care products. In Canada, Section
9(1) of the Food and Drugs Act states that “no person shall label, package, treat,
process, sell or advertise any drug in a manner that is false, misleading or
deceptive or is likely to create an erroneous impression regarding its composition,
merit or safety.”Since the terms and any proposed indication of unlicensed
healthcare products have not been established, advertising such products is not
permitted Similar provisions are laid out in the US Code of Federal Regulations
(CFR), Title 21, section 312.7(a) and 812.7(a)the promotion of any investigational
drug or medical device (including a new use under investigation for an existing
device) is expressly prohibited.
`
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37. REGULATORY AFFAIRS :
Unlicensed and licensed products:
Advertising and promotion
Why the promotion or advertising of unlicensed
healthcare products is prohibited ?
The primary concern about the promotion or
advertising of unlicensed healthcare products or off-
label uses is that a healthcare provider may form an
opinion about a product’s use on the basis of the
claims made by its company before it receives
regulatory approval, and that opinion may be incorrect
relative to the pending regulatory approval. Such an
erroneous opinion on the part of the healthcare
provider could lead to incorrect use of the licensed
product, thus using the product off-label.
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38. REGULATORY AFFAIRS :
a) Advertising licensed healthcare products
According to the Section 2 of Canada’s Food and Drugs Act, an advertisement
includes “any representation by any means whatever for the purpose of promoting
directly or indirectly the sale or disposal of any food, drug, cosmetic or device.
Promotion can take on many forms, including
Advertisements
Internet sites
Brochures
Exhibition panel
Gifts
Samples
Reprints
Product monographs
A sales representative’s activities
Training materials or briefings
Press releases
Meetings or symposia
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39. REGULATORY AFFAIRS :
Different regulatory bodies have different views on
advertising healthcare products :
Regulatory systems are in place to safeguard the public from false and
misleading advertising of healthcare products. However, among
jurisdictions, these systems differ on what constitutes advertising and
promotional activities, and thus their regulations and enforcement vary
as well. To ensure you comply with industry regulations, understand the
local requirements.
In Canada, advertising is primarily self-regulated and materials are
submitted for preclearance on a voluntary basis. Health Canada is
ultimately responsible for enforcement (e.g., in cases when advertising
may present a significant health hazard such as when a prescription
drug is illegally advertised to the general public or an unauthorized
health product is promoted
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40. REGULATORY AFFAIRS :
SOPs to keep advertising in compliance with
regulations:
Promotional activities should be consistent with the product labelling that
has been cleared or approved.
Promotional claims should be reliable, accurate, truthful, informative, fair,
balanced and up-to-date, and you must be able to substantiate them.
The information should not contain misleading or unverifiable statements
or omissions likely to induce medically unjustifiable product use or to
give rise to undue risks.
Any comparison of products should be factual and fair, and you must be
able to substantiate it.
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