1. The Office of Regulatory Affairs (ORA) conducts field work for the FDA including over 17,000 inspections worldwide each year.
2. Within ORA, the Office of Medical Device and Radiological Health Operations (OMDRHO) leads the medical device program and conducts inspections and regulatory activities.
3. Key OMDRHO staff include Consumer Safety Officers, Compliance Officers, and Recall Coordinators who are involved in inspection, compliance, and recall activities to ensure medical devices and radiation emitting products are safe.
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.
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'.
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 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.
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'.
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.
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...ComplianceOnline
This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
The introduction of Identification of Medicinal Products (IDMP), as developed by the International Organization for Standardization (ISO), marks the next phase of evolution for the European drug dictionary project under Article 57.
The European Medicines Agency (EMA) will issue guidance based on five documents published by the ISO, which will require life sciences companies to use a "set of common global standards for data elements, formats, and terminologies for the unique identification and exchange of information on medicines."
Complying with IDMP represents a massive increase in scope and complexity, in addition to previous iterations. The EMA has divided the timeline for meeting the new requirements into several phases, making this a multi-year project.
Perficient’s expert in IDMP and the EudraVigilance Medicinal Product Dictionary, Mark Thackstone, reviewed everything you need to know in order to successfully comply with IDMP by the fast-approaching deadline:
-Latest information and timelines
-Steps to take meet regulatory requirements
-Challenges and factors to consider
-What IDMP means in the real world of a typical pharma company
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
an independent, non-governmental membership organization and the world's largest developer of voluntary International Standards.The HACCP system is based on organisation and is guided by a policy and objective with clearly defined responsibilities, allotted resources and control over how objective are met.
FDA Update: Inspections, Observations and Metrics - OMTEC 2017April Bright
This FDA-focused presentation offers a glimpse into trends behind three initiatives that orthopaedic device professionals need to fully understand: inspections, Case for Quality and 483 Observations. First, a high-level view of FDA inspections will discuss methodology and implementation. Second, FDA’s observations of non-compliance will be discussed, pointing out important historical trends. Finally, as the industry matures, professionals should expect changes to the breadth and depth of FDA’s focus. This is where Case for Quality and the Medical Device Metrics Initiative will be covered. FDA has placed an increased emphasis on data and metrics. Gain insight into ways to leverage data to improve, monitor and control processes that drive quality improvement.
Good manufacturing practices for complementary medicinesTGA Australia
This presentation provides an overview of GMP clearance application process, the TGA compliance risk framework, major deficiencies and manufacturing quality challenges.
An industrial hygiene program is critical to environmental, health and safety. A good program can maximize worker health and safety, while a poor program can compromise safety and lead to frustration and confusion. The implementation and ongoing management of your employees' health and safety depends on a well-designed and properly executed industrial hygiene program.
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...ComplianceOnline
This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
The introduction of Identification of Medicinal Products (IDMP), as developed by the International Organization for Standardization (ISO), marks the next phase of evolution for the European drug dictionary project under Article 57.
The European Medicines Agency (EMA) will issue guidance based on five documents published by the ISO, which will require life sciences companies to use a "set of common global standards for data elements, formats, and terminologies for the unique identification and exchange of information on medicines."
Complying with IDMP represents a massive increase in scope and complexity, in addition to previous iterations. The EMA has divided the timeline for meeting the new requirements into several phases, making this a multi-year project.
Perficient’s expert in IDMP and the EudraVigilance Medicinal Product Dictionary, Mark Thackstone, reviewed everything you need to know in order to successfully comply with IDMP by the fast-approaching deadline:
-Latest information and timelines
-Steps to take meet regulatory requirements
-Challenges and factors to consider
-What IDMP means in the real world of a typical pharma company
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
an independent, non-governmental membership organization and the world's largest developer of voluntary International Standards.The HACCP system is based on organisation and is guided by a policy and objective with clearly defined responsibilities, allotted resources and control over how objective are met.
FDA Update: Inspections, Observations and Metrics - OMTEC 2017April Bright
This FDA-focused presentation offers a glimpse into trends behind three initiatives that orthopaedic device professionals need to fully understand: inspections, Case for Quality and 483 Observations. First, a high-level view of FDA inspections will discuss methodology and implementation. Second, FDA’s observations of non-compliance will be discussed, pointing out important historical trends. Finally, as the industry matures, professionals should expect changes to the breadth and depth of FDA’s focus. This is where Case for Quality and the Medical Device Metrics Initiative will be covered. FDA has placed an increased emphasis on data and metrics. Gain insight into ways to leverage data to improve, monitor and control processes that drive quality improvement.
Good manufacturing practices for complementary medicinesTGA Australia
This presentation provides an overview of GMP clearance application process, the TGA compliance risk framework, major deficiencies and manufacturing quality challenges.
An industrial hygiene program is critical to environmental, health and safety. A good program can maximize worker health and safety, while a poor program can compromise safety and lead to frustration and confusion. The implementation and ongoing management of your employees' health and safety depends on a well-designed and properly executed industrial hygiene program.
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
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
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
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
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.
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stockrebeccabio
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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.
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
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journey
ORA A Day In the Life - Introduction - Module 1.pptx
1. Office of Regulatory Affairs:
An Introduction
James Hildreth
Supervisory Consumer Safety Officer
Office of Medical Device and Radiological Health Operations (OMDRHO), Division 3
Office of Regulatory Affairs
U.S. Food and Drug Administration
2. Did You Know?
• A specialized FDA section is dedicated to field work
– Office of Regulatory Affairs (ORA)
• ORA completes over 17,000 inspections world-wide
every year
2
3. Presentation Series:
Day In the Life
• 5 Modules
1. Introduction
2. Consumer Safety Officer
3. Supervisory Consumer Safety Officer
4. Compliance Officer
5. Recall Coordinator
3
4. Learning Objectives
1. Describe the basic function of FDA’s Office of Regulatory Affairs
2. Discuss the characteristics and functions of Program Alignment
3. Describe the features of the Office of Medical Device and
Radiological Health Operations
4. Identify the primary work products and staff titles in ORA
4
8. Where is ORA in FDA Structure?
Food And Drug
Administration
6 Centers* 8 Offices*
1 Center of
Excellence
Office of
Regulatory
Affairs
8
* FDA Centers/Offices grouped together to simplify this chart; Official organization chart may be found at:
www.fda.gov/media/121839/download
9. Program Alignment
• Groups ORA employees together by product
type
• Staff responsible for same products work
together across the United States
9
11. Program Alignment: Objectives
• Integrates FDA staff working with same products
• Optimizes coordination between ORA and FDA Centers
• Enables staff to work more closely with FDA experts
• Strengthens accountability and reduces duplication
11
12. Program Alignment: Objectives
• Strengthens FDA workforce to improve public health
response
• Aligns with regulated industry alignment by product
type
12
14. Office of Medical Device and
Radiological Health Operations
• Medical Device program within ORA
• Also known as “OMDRHO”
• Staff specialize in one of three areas:
– Medical Devices
– Radiological Health
– Mammography
14
15. Location of OMDRHO in FDA Structure
15
Food and Drug
Administration
(FDA)
Center for Devices
and Radiological
Health (CDRH)
Office of Regulatory
Affairs (ORA)
Office of Medical Devices
and Radiological Health
Operations (OMDRHO)
Note: FDA Centers/Offices unrelated to medical devices are not shown
16. Cooperative Relationship with CDRH
16
Food and Drug
Administration
(FDA)
Center for Devices
and Radiological
Health (CDRH)*
Office of Regulatory
Affairs (ORA)
Office of Medical Devices
and Radiological Health
Operations (OMDRHO)*
*Cooperative
Relationship
17. Cooperative Relationship with CDRH
• Expert resources provided
• Partnership on annual workplans and priorities
• Coverage of total product lifecycle
17
18. OMDRHO
Structure
18
Immediate Office
Lead: Program
Director
Division
Lead: Program
Division Director
Compliance Branch
Lead: Director,
Compliance Branch
Compliance Officers Recall Coordinators
Investigations Branch
Lead: Director,
Investigations Branch
Supervisory
Consumer Safety
Officers
Consumer Safety
Officers
23. Types of Inspections
• Routine or surveillance
• Directed or For-Cause
• Risk-based Workplan
• Premarket Approval Application (PMA)
• Postmarket Surveillance
• Domestic/Foreign
23
24. Inspection Process
• Gather information from manufacturer
• Evaluate inspectional findings
• Document findings and make recommendations
• May lead to regulatory action, such as warning
letter or recall
24
25. Recall
• Originated when a manufacturer addresses
product issue through a recall
• Categorized into Class based on risk
– Class I: highest risk
• Terminated upon resolution of recall issue
25
27. ORA Numbers (FY2018)
• 16,336 Domestic Inspections
• 3,736 Foreign Inspections
• 43,099 Samples collected and analyzed
• 43.6 million lines of Imported Products reviewed
• 14,285 Warning Letters Issued
• 7,562 Recalled Products
27
28. Comparison of OMDRHO and ORA
(FY2018)
28
Function OMDRHO ORA
Domestic Inspections 1,690 16,336
Foreign Inspections 515 3,736
Warning Letters 31 14,285
Recalled Products 3,173 7,562
Injunctions 2 7
Data may be found at: https://www.fda.gov/about-fda/transparency/fda-data-dashboard
29. For General Assistance
• Contact OMDRHO Immediate Office:
– Foreign Inspections
– Radiological Health Response
– Mammography
• Contact Divisions 1 – 3
– Other Programs, Questions or Issues
29
30. References and Resources
• Office of Regulatory Affairs
www.fda.gov/about-fda/office-global-regulatory-operations-and-policy/office-
regulatory-affairs
• Program Alignment and ORA
www.fda.gov/about-fda/office-regulatory-affairs/program-alignment-and-ora
• ORA Program Division Boundary Maps and Fact Sheets
www.fda.gov/about-fda/office-regulatory-affairs/ora-program-division-boundary-
maps-and-fact-sheets
30
31. Summary
• FDA’s Office of Regulatory Affairs (ORA) conducts the field work for FDA
• ORA’s Program Alignment organizes this work by product type
• Office of Medical Device and Radiological Health Operations leads the
medical device program for ORA
• The field work involves a large number of staff who conduct inspections and
field work in order to ensure that products are safe and effective
31
32. Your Call to Action
1. Refer to the OMDRHO boundary map to determine
which division covers your geographic area.
2. View the remaining modules in this series to learn
more about the individual OMDRHO staff roles.
32
33. Presentation Series:
Day In the Life
• 5 Modules
1. Introduction
2. Consumer Safety Officer
3. Supervisory Consumer Safety Officer
4. Compliance Officer
5. Recall Coordinator
33