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.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
COPP/CPP it certification of pharmaceutical product for reviewing QSE i.e. Quality, Sefty,Efficacy of product. it important certification for exporting it may required by importing country.
Pilot Plant:-
“Defined as a part of pharmaceutical industry where a lab scale formula is transformed into viable product by the development of liable practical procedure for manufacture”.
Scale-up:-
“The art of designing of prototype using the data obtained from the pilot plant model”
Granularity of Technology Transfer Process, Documentation, Premises and equipment Qualification and Validation. Premises and equipments. Quality control: Analytical Method Transfer. Qualification and Validation
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
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
Regulatory Affairs is a 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.
Indian regulatory requirements - industrial pharmacy 2Jafarali Masi
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs
Regulatory Requirements For New Drug Approval.
This topic is from Industrial Pharmacy-II, B.Pharm Final year VIIth semester.
It include rule and regulations related to new drug approval for clinical use.
Quality management systems - INDUSTRIAL PHARMACY llJafarali Masi
syllabus
Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
Pilot Plant:-
“Defined as a part of pharmaceutical industry where a lab scale formula is transformed into viable product by the development of liable practical procedure for manufacture”.
Scale-up:-
“The art of designing of prototype using the data obtained from the pilot plant model”
Granularity of Technology Transfer Process, Documentation, Premises and equipment Qualification and Validation. Premises and equipments. Quality control: Analytical Method Transfer. Qualification and Validation
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
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
Regulatory Affairs is a 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.
Indian regulatory requirements - industrial pharmacy 2Jafarali Masi
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs
Regulatory Requirements For New Drug Approval.
This topic is from Industrial Pharmacy-II, B.Pharm Final year VIIth semester.
It include rule and regulations related to new drug approval for clinical use.
Quality management systems - INDUSTRIAL PHARMACY llJafarali Masi
syllabus
Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
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
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
Regulatory Affairs Excellence: Staffing and Performance in Medical Device Com...Best Practices
Regulatory affairs group ensure that medical device companies comply with volatile regulatory environment pertaining to developing and marketing medical device products. These specialized groups rely on their own internal effectiveness and efficiencies for enhanced performance under stringent compliance norms. Also, optimal resourcing and staffing helps Regulatory Affairs groups in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth.
Best Practices, LLC conducted this benchmarking study to establish meaningful metrics and insights around the structure, activities, roles and responsibilities of Regulatory Affairs groups at medical device companies. The study also provides recent spend and staffing trends of regulatory affairs in medical device sector, including the use of outsourcing and off-shoring.
Medical device regulatory leaders can use this study to align their staff as per strategies of best in class companies for an increased performance delivery.
Carlos Langezaal - Eisai Inc, Speaker at the marcus evans Discovery Summit Fall 2011, delivers his presentation on The Importance of Developing a Global Regulatory Strategy towards the Goal of Registration
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.
201 regulatory aspects of drug and cosmetics .pdfBhavikaAPatel
regulatory aspects of drug and cosmetics
1. Regulatory Requirements for Registration of Drugs & Post Approval Requirements in WHO through Prequalification Program
2. FDA ORGANIZATION CHART
3. Marketing Authorization of EU for APPLICATION PROCEDURES
4. Global Countries Classification
5. Organization and structure of EMA&EDQMActive substance Master files IMPD
6. DRUG MASTER FILE in USA
What Is An Assistant Drug Controller (Adc) Noc In India And Why Is It Importa...PranshuCorpseed
The pharmaceutical industry plays a pivotal role in public health by manufacturing and distributing drugs and medical products. To ensure the safety, quality, and efficacy of pharmaceuticals, governments around the world have established stringent regulatory frameworks. In India, the Assistant Drug Controller (ADC) assumes a crucial role in this regulatory process. This article delves into the significance of an Assistant Drug Controller (ADC) No Objection Certificate (NOC) in India and its pivotal role in the pharmaceutical sector.
The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods in Australia.
The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard.
Product type- Drug development - Departments of facility- Registration pathwa...Asmaa Khalil
In this video you will know the detailed information about:
🔸Departments of the manufacturing sites.
🔸Steps of drug product development.
🔸Regulatory Affairs department.
🔸Registration pathway.
🔸Product Type (Innovator "RLD" / Generic / Hybrid).
🔸All medicines must grant a Marketing Authorization (MA) in order to be placed on the market legally in the country.
🔸The ultimate purpose of marketing authorization is to ensure that safe, effective & high-quality medicines, as to protect public health.
https://youtu.be/edUEFt681iM
#asmaa_khalil_ctd
7th Pharmacovigilance 2014 “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management" 21st November 2014, Kohinoor Continental Hotel, Mumbai, India Greetings from Virtue Insight, I am happy to invite you and your colleagues to be a sponsor / delegate for our upcoming conference. The “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management” at 7th Pharmacovigilance 2014 on 21st November 2014, Kohinoor Continental Hotel, Mumbai, India.Contact:-Tel: +91 9677590192 Email: dinesh@virtueinsight.co.in
I am writing to make you aware of our upcoming event:- 7th Pharmacovigilance 2014 taking place on 21st November 2014, Kohinoor Continental Hotel, Mumbai, India.
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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
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
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
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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
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.
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
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
2. • Pharmaceutical & Clinical Research Industry most
regulated among all the industries.
• Every drug before getting market approval must
undergo rigorous scrutiny and clinical
trials to ensure its Safety, Efficacy &
Quality.
• Standards are set by regulatory
authorities.
• RA department acts as a crucial link between
company, products & regulatory authorities.
Introduction
2
InstituteofPharmaceuticalManagement
3. What is DRA??
• Unique mix of science and management to achieve a
commercially important goal.
• It touches everything relating to drugs from the
development manufacture and marketing.
• RA takes care of
Design = Development Plan
Co-ordination = Writing/
reviewing, supervising
Construction = Assembling &
Submission management
3
InstituteofPharmaceuticalManagement
4. • Lifecycle management ranges from
Drug Discovery post-marketing stage of the
process.
• From Drug development to commercialization, each
step is regulated.
Scope
4
InstituteofPharmaceuticalManagement
5. Responsibilities of RA
professional
• Keep up-to-date about international
legislation, guidelines and customer practices.
• Update with company's product range.
• Compliance of company's product with
current regulations
• Impart training to R&D, Pilot plant, ADL on
current regulatory requirements
• Formulate regulatory submission strategies.
6
InstituteofPharmaceuticalManagement
6. • Prepare IMPD, DMF, ANDA, MAA, Dossiers
amendments & supplements etc as per
regional guidelines, submit them to
regulatory authorities in a specified time
frame
• Monitor progress of all registration
submissions
7
Responsibilities of RA
professional [Contd…]
InstituteofPharmaceuticalManagement
7. • Respond to queries as they arise and ensure
that registration/approvals are granted
without delay.
• Handle regulatory and customer inspections,
review audit reports and compliance
• Arranges consultations and meetings
between the firm and government
regulatory agencies
8
Responsibilities of RA
professional [Contd…]
InstituteofPharmaceuticalManagement
8. 9
• Company success
depends on reduction of
time taken for a drug to
reach market.
• Inadequate reporting of
data may prevent a
timely positive
evaluation of a
marketing application
• Proper conduct of RA
activities is therefore
of considerable
economic importance
for the company.
NO DMF/
DOSSIER NO REGISTRATION
NO SALE
Importance of RA
InstituteofPharmaceuticalManagement
10. Country Name of Regulatory Authority Website
USA Food and Drug Administration
[FDA]
www.fda.gov
Europe European Directorate for the
Quality of Medicines and
Healthcare (EDQM)
www.edqm.eu
European Medicines Agency (EMA) www.ema.europa.eu
Heads of Agencies for the European
Union
http://www.hma.eu/ 10
InstituteofPharmaceuticalManagement
11. Country Name of Regulatory Authority Website
Japan Ministry of Health, Labour and
Welfare (MHLW)
www.mhlw.go.jp/english
Pharmaceuticals and Medical Devices
Agency (PMDA) www.pmda.go.jp/english/
UK Medicines and Healthcare products
Regulatory Agency (MHRA)
www.mhra.gov.uk
India Central Drugs Standard Control
Organization.
www.cdsco.nic.in
11
InstituteofPharmaceuticalManagement
12. How to Keep Up With the Constantly
ChangingRegulatoryLandscape?
Monitor Agency’s
websites
Subscribe to relevant
journals, newsletters
Get daily e-mails
from regulatory
websites, commercial
information provider
websites
22
Attend relevant
conferences/advis
ory meetings
Talk to colleagues
and consultants
Employ a
regulatory
information
database In-house
or Paid
Joining
information blogs
InstituteofPharmaceuticalManagement