View this presentation for information on:
what postmarket monitoring is and why it is important
tools used in postmarket monitoring, including risk management plans
managing risk and adverse events
the TGA's early warning system and recall actions.
IPO Fast Forward 2013: Medical Apps Event @ Maidstone & Tunbridge Wells NHS Trust. UK Medical Device regulator presentation from Rob Higgins, MHRA.gov.uk (Reproduced with permission)
Changes to the regulation of autologous cells and tissuesTGA Australia
Presentation provides an overview of the changes to the regulation of autologous HCT, inlcuding guidance on restrtictions to advertiisng content and the need to report advert events.
The regulation of biologicals in AustraliaTGA Australia
View this presentation for information on:
* what biologicals are, including classes and current uses
* the Australian biologicals framework
* new and experimental products
* clinical trials and risk management.
Pharmacovigilance and complementary medicines - Regulatory requirementsTGA Australia
Presentation on Pharmacovigilance basics – sponsor obligations, Complementary medicine safety – Regulatory perspective and Special considerations for complementary medicine pharmacovigilance
TGA Presentation: TGA’s Role in Clinical Trials Regulation and AdministrationTGA Australia
An overview of supplying ‘unapproved’ therapeutic goods in clinical trials, Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) Schemes, TGA and Stakeholders Responsibilities, Safety reporting and other regulatory requirements, Clinical trials FAQs, and the Australian Clinical Trials Handbook update
Postmarket monitoring of therapeutic goods in AustraliaTGA Australia
View this presentation for information on:
* what postmarket monitoring is and why it is important
* tools used in postmarket monitoring, including risk management plans
* managing risk and adverse events
* the TGA's early warning system and recall actions.
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
IPO Fast Forward 2013: Medical Apps Event @ Maidstone & Tunbridge Wells NHS Trust. UK Medical Device regulator presentation from Rob Higgins, MHRA.gov.uk (Reproduced with permission)
Changes to the regulation of autologous cells and tissuesTGA Australia
Presentation provides an overview of the changes to the regulation of autologous HCT, inlcuding guidance on restrtictions to advertiisng content and the need to report advert events.
The regulation of biologicals in AustraliaTGA Australia
View this presentation for information on:
* what biologicals are, including classes and current uses
* the Australian biologicals framework
* new and experimental products
* clinical trials and risk management.
Pharmacovigilance and complementary medicines - Regulatory requirementsTGA Australia
Presentation on Pharmacovigilance basics – sponsor obligations, Complementary medicine safety – Regulatory perspective and Special considerations for complementary medicine pharmacovigilance
TGA Presentation: TGA’s Role in Clinical Trials Regulation and AdministrationTGA Australia
An overview of supplying ‘unapproved’ therapeutic goods in clinical trials, Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) Schemes, TGA and Stakeholders Responsibilities, Safety reporting and other regulatory requirements, Clinical trials FAQs, and the Australian Clinical Trials Handbook update
Postmarket monitoring of therapeutic goods in AustraliaTGA Australia
View this presentation for information on:
* what postmarket monitoring is and why it is important
* tools used in postmarket monitoring, including risk management plans
* managing risk and adverse events
* the TGA's early warning system and recall actions.
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
Presentation: Updates from the Pharmacovigilance and Special Access BranchTGA Australia
This presentation covers using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program update, international collaboration activities and Adverse Event Management System.
Presentation: Regulation of autologous cells and tissuesTGA Australia
This presentation provides an overview and describes the recent TGA public consultation on the exclusion of some autologous cell therapies from regulation.
Spotlight on MMDR Further Reviews and Advertising ReformsTGA Australia
An overview of reform initiatives relating to low risk therapeutic goods and the scheduling policy framework arising from the Review of Medicines and Medical Devices Regulation.
An introduction to the work of Australia's regulator of therapeutic goodsTGA Australia
View this presentation for information on:
* who we are, how we regulate, and why we need regulation
* the different types of therapeutic goods and the Australian Register of Therapeutic Goods
* our benefit versus risk approach to regulation
* the activities we undertake both before and after a product is released to the market
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.
Presentation: Updates from the Therapeutic Goods Administration - For medicin...TGA Australia
The presentation outlines how the TGA’s new priority review pathway for prescription medicines works and how medicines might be deemed to be a priority for Australian patients. We discuss how the provisional approval pathway contributes to early access and how to judge when early data seems promising.
TGA presentation: AusMedtech, 24 May 2017 TGA Australia
This presentation outlines reforms to the device regulatory system following the Expert Panel Review of Medicines and Medical Devices Regulation, reforms to the in vitro diagnostic devices (IVD) regulatory framework, reforms to the European and IVD system and the TGA's new Clinical Evidence Guidelines.
TGA Presentation: What’s happening in regulation?TGA Australia
This presentation provides an overview of the Government's response to the Expert Panel Review of Medicines and Medical Devices, with an emphasis on complementary medicines changes.
Presentation on the background of medicine shortages, definitions, reporting requirements, assessment and management, Section 19A and the compliance framework
Better medicine labels: New requirements under TGOs 91 and 92TGA Australia
This presentation discusses the recent changes to medicines labelling in Australia including the history and consultation as well as the changes and features brought in with Therapeutic Goods Order No. 79.
Pharmacovigilance - a regulator's perspectiveTGA Australia
This presentation provides an overview of the TGA's Pre-market and Post-market pharmacovigilance methods. It describes the role and content of Risk Management Plans as well as adverse event reporting and signal detection and investigation.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
Presentation: Updates from the Pharmacovigilance and Special Access BranchTGA Australia
This presentation covers using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program update, international collaboration activities and Adverse Event Management System.
Presentation: Regulation of autologous cells and tissuesTGA Australia
This presentation provides an overview and describes the recent TGA public consultation on the exclusion of some autologous cell therapies from regulation.
Spotlight on MMDR Further Reviews and Advertising ReformsTGA Australia
An overview of reform initiatives relating to low risk therapeutic goods and the scheduling policy framework arising from the Review of Medicines and Medical Devices Regulation.
An introduction to the work of Australia's regulator of therapeutic goodsTGA Australia
View this presentation for information on:
* who we are, how we regulate, and why we need regulation
* the different types of therapeutic goods and the Australian Register of Therapeutic Goods
* our benefit versus risk approach to regulation
* the activities we undertake both before and after a product is released to the market
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.
Presentation: Updates from the Therapeutic Goods Administration - For medicin...TGA Australia
The presentation outlines how the TGA’s new priority review pathway for prescription medicines works and how medicines might be deemed to be a priority for Australian patients. We discuss how the provisional approval pathway contributes to early access and how to judge when early data seems promising.
TGA presentation: AusMedtech, 24 May 2017 TGA Australia
This presentation outlines reforms to the device regulatory system following the Expert Panel Review of Medicines and Medical Devices Regulation, reforms to the in vitro diagnostic devices (IVD) regulatory framework, reforms to the European and IVD system and the TGA's new Clinical Evidence Guidelines.
TGA Presentation: What’s happening in regulation?TGA Australia
This presentation provides an overview of the Government's response to the Expert Panel Review of Medicines and Medical Devices, with an emphasis on complementary medicines changes.
Presentation on the background of medicine shortages, definitions, reporting requirements, assessment and management, Section 19A and the compliance framework
Better medicine labels: New requirements under TGOs 91 and 92TGA Australia
This presentation discusses the recent changes to medicines labelling in Australia including the history and consultation as well as the changes and features brought in with Therapeutic Goods Order No. 79.
Pharmacovigilance - a regulator's perspectiveTGA Australia
This presentation provides an overview of the TGA's Pre-market and Post-market pharmacovigilance methods. It describes the role and content of Risk Management Plans as well as adverse event reporting and signal detection and investigation.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problem.
All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use.
The clinical trial process involves studying these products in a relatively small number of selected individuals for a short period of time.
Certain side effects may only emerge once these products have been used by a heterogenous population, including people with other concurrent diseases, and over a long period.
PHARMACOVIGILANCE - A Worldwide masterkey for Drug MonitoringVenugopal N
Pharmacovigilance is the pharmacological science that aims at the detection, assessment, monitoring, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines to ensure drug safety.
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It plays a crucial role in ensuring the safety and monitoring the risks associated with pharmaceutical products throughout their lifecycle, from pre-market clinical trials to post-marketing surveillance.
Here are some key aspects of pharmacovigilance and drug safety:
Adverse Drug Reaction (ADR) Monitoring: Pharmacovigilance systems aim to identify and monitor adverse drug reactions, which are harmful and unintended responses to medications. Healthcare professionals and patients are encouraged to report suspected ADRs to regulatory authorities or pharmacovigilance programs, enabling the ongoing collection and analysis of safety data.
Signal Detection: Pharmacovigilance activities involve the systematic monitoring and analysis of safety data to identify potential signals or patterns that may indicate new or previously unrecognized risks associated with a drug. This involves the use of various tools and methods, such as data mining, statistical analysis, and signal management, to detect and investigate potential safety concerns.
Benefit-Risk Assessment: Pharmacovigilance plays a critical role in assessing the balance between the benefits and risks of medications. By collecting and analyzing safety data from various sources, including clinical trials and post-marketing surveillance, regulators and healthcare professionals can evaluate the overall benefit-risk profile of drugs and make informed decisions regarding their use.
Regulatory Reporting: Pharmaceutical companies are required to report safety data and suspected adverse reactions to regulatory authorities as part of their regulatory obligations. These reports provide important information for regulatory decision-making, including labeling updates, contraindications, or restrictions on drug use.
Post-Marketing Surveillance: Once a drug is approved and available on the market, pharmacovigilance activities continue to monitor its safety in real-world clinical practice. Post-marketing surveillance systems track and evaluate the safety of drugs in larger and more diverse patient populations, detecting rare or long-term adverse events that may not have been identified during clinical trials.
Risk Management Strategies: Pharmacovigilance also involves the development and implementation of risk management strategies to minimize or mitigate known risks associated with specific drugs. This may include prescribing restrictions, monitoring requirements, educational materials for healthcare professionals and patients, and communication of safety information.
International Collaboration: Pharmacovigilance operates on a global scale, with international collaboration and information sharing being essential for timely detection and response to drug safety issues. Regulatory agencies, healthcare organizations, and pharmacovigilance netw
The regulation of medical devices in AustraliaTGA Australia
View this presentation for information on:
* what are medical devices, and how they compare to medicines in terms of regulation
* the process for a device to get to market and how they are classified according to risk
* the essential principles and conformity assessment
* safety and performance of devices.
The challenges of regulating direct to consumer digital medical devicesTGA Australia
Presentation on digital medical devices, the role of the regulator, challenges in applying the framework to digital devices, international approaches and what is the TGA doing
Updates from the Pharmacovigilance and Special Access Branch TGA Australia
Presentation on using new sources of data in Pharmacovigilance, Pharmacovigilance Inspection Program (PVIP) update, International collaboration activities, Adverse Event Management System (AEMS)
Q and A
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Update on regulatory reforms from the Scientific Evaluation BranchTGA Australia
Presentation on the latest on variations, Generic Medicines Reform Program, Human cells and tissue regulation (excluded goods), Faecal Microbiota Transplantation and 2D DataMatrix codes for medicines
Regulatory updates from the TGA Medical Devices Branch - Part 1TGA Australia
Presentation on the review of medicines and medical devices regulation, proposed changes to some definitions and regulation of some products without a medical purpose, reclassification of medical devices (not IVD), Unique Device Identification System and post-market monitoring
Regulatory updates from the TGA Medical Devices Branch - Part 2TGA Australia
Presentation on the regulation of software including software as a medical device, proposed regulatory scheme for personalised medical devices, including 3D Printed Devices, proposed changes to the Essential Principles, Conformity Assessment Procedures, and the requirements for devices used in clinical trials, and clarifying the requirements for systems and procedure packs
SME Assist: Help to navigate the regulatory mazeTGA Australia
Presentation to provide information on TGA’s SME Assist and what the service offers, details on upcoming SME Assist events and information on where to find more help
This presentation highlights some of the changes in Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019, compared to the previous Order, Therapeutic Goods Order No. 78 – Standard for tablets and capsules.
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.
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
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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
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.
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
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
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
2. Overview
• What is postmarket monitoring?
• Why is it important?
• Tools used in postmarket monitoring
• Managing risk
• Adverse events
• Risk management plans
• Signals
• Recall actions
• Pharmacovigilance Inspection
Program
• Other education modules
2
3. What is postmarket monitoring?
The aim is to continually monitor
and evaluate the safety and, in
some cases, the efficacy or
performance of therapeutic goods
that are available on the market
and to manage any risks
associated with individual
products.
We regulate
therapeutic
goods
throughout their
lifecycle in a
number of ways
Enforce
compliance
Monitor
Changes to product information,
safety alerts, recalls
RegisterAssess evidence
3
4. Why is this important?
Not all risks can be identified before registration
Vioxx was first approved in
Australia in 1999 for
symptomatic treatment of
osteoarthritis and
rheumatoid arthritis.
Postmarket study showed
an increased risk of
cardiovascular events
beginning after 18 months
of treatment in patients
taking the recommended
daily dose.
Compared with placebo,
this equated to one extra
cardiovascular event for
each 65 patients who took
Vioxx for at least 18
months.
Vioxx was withdrawn
from the market
worldwide in 2004.
This was one catalyst for
more vigorous postmarket
monitoring for regulators
around the world.
4
5. Tools used in postmarket monitoring
Risk management
plans (RMPs)
Adverse event
reporting
and
Pharmacovigilance
Inspection Program
(PVIP)
Environmental
scanning (seeking
confidential advice
from other regulators
and review of medical
literature, regulatory
news, media and
other sources)
As a future health professional, you can help by learning how to report adverse events 5
6. Managing risk
• The TGA works on a risk-benefit
assessment of products at a
population level. The benefit of
taking the medicine or using the
device should be greater than
the possible adverse events.
• Higher levels of risk may be
acceptable for a product used to
treat a terminal illness, but not for
a common or minor complaint.
6
7. Definition of an
adverse event
For both medicines and medical
devices: an event that resulted in, or
could have resulted in, serious
injury, illness or death.
A medical device adverse event can also be associated with
the use (or misuse) of a medical device. This may include
difficulties or malfunctions, such as problems with getting the
device to operate, the need for repeated repairs, difficulty of
use or difficulty with cleaning after use.
7
8. Your role as a health professional
• You play an important
role in monitoring the
safety of therapeutic
goods by reporting
any suspected
adverse events to the
TGA.
• Reports can be made online, or by
phone, fax or email.
• Visit the TGA website for more
information about reporting.
www.tga.gov.au
Search the databases of adverse event notifications to see what has been reported to the TGA 8
8
9. What should you report?
The TGA is particularly interested in:
• serious or unexpected reactions to medicines
(this is explained further on the next slide)
• serious medicine interactions
• faults or problems with medical devices that have resulted, or could have
resulted, in adverse events.
9
10. Reporting serious and unexpected
reactions to medicines
It is most important to report serious and unexpected
reactions to medicines. These are distinct from well
known side effects. For example, we would not expect
reports of:
• tiredness after taking an opiate based painkiller
• nausea or diarrhoea after taking certain antibiotics.
10
11. Who currently reports adverse events?
2016 data
* There are mandatory reporting requirements for industry.
The TGA is developing strategies to encourage increased reporting by health professionals and consumers
11
12. Why Risk Management Plans? (RMPs)
Real-world use of a medicine or biological identifies issues that may not
have been discovered during a clinical trial
RMPs are completed by sponsors as part of the registration
process for high-risk medicines and biologicals (made from or
contains human cells or human tissue)
They outline the risk management system for a product
once it is available for use in Australia
RMPs are living documents that cover the lifecycle of a
product and inform the periodic safety update reports
12
13. Key elements of an RMP
Safety specification
Safety profile of a medicine or biological, including known
and potential safety concerns
Pharmacovigilance activities
Plan for how safety concerns will be monitored and how
further information will be collected
Risk minimisation activities
Plan for how the risks associated with the use of the
product will be minimised
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14. Safety signals
How we respond
• Signals are information collected from one
or more sources that show a potentially
causal relationship between a product and
an adverse event.
• There are three steps in the signal
investigation process.
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15. Step 1 – detecting signals
Involves a review of adverse event
reports, international monitoring
activities and reports, published
literature and post-approval studies
to identify harmful effects
TGA
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16. Step 2 – assessing signals
Involves determining the:
• nature
• magnitude
• health significance
of potential safety problems and their impact
on the overall risk-benefit of the product.
This process takes into consideration factors
such as whether it is a serious adverse event
in a few patients or a moderate adverse event
in a large number of patients.
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17. Step 3 – responding to signals
Regulatory actions taken to mitigate risk include:
• communication of information for consumers, health
professionals and industry regarding the problem
• alteration of the product label
• recall of goods from sale or use, or for correction
• changes to the conditions of registration
• suspension or cancellation of the product.
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18. Case study – one report can make a difference
Report that an epidural catheter, which is normally clear,
was yellow when removed from the packaging for use.
Upon testing, the yellow catheter was found to be
cytotoxic. New, clear catheters (of the same brand)
were also found to be cytotoxic.
Further analysis found a plasticiser used to soften the
catheter, n-butyl benzene sulfonamide, is a neurotoxin.
The manufacturer had been using it for 30 years with
no reports of related adverse events.
The catheter was reformulated wordwide due to the
TGA’s discovery.
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19. Case study – a handful of reports can uncover
previously unknown safety issues
The TGA received eight reports of serious liver injury associated with
the use of lumiracoxib (an anti-inflammatory used to treat osteoarthritis)
including two fatalities, two liver transplants, severe jaundice and acute
hepatitis without liver failure.
The TGA investigated the reports and received expert advice that the
apparent rate of severe liver injury with lumiracoxib appeared greater
than for other similar medicines.
The TGA immediately cancelled the registration of all forms of
lumiracoxib in Australia, on the grounds that failure to do so would create
an imminent risk of death, serious illness or serious injury.
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20. Recall actions
A recall action is taken to resolve a problem with a
therapeutic good already supplied in the market. There
are three distinct types of recall actions:
• Recall: The permanent removal of an affected
therapeutic good from supply or use in the market.
• Recall for product correction: Repair, modification,
adjustment or re-labelling of a therapeutic good.
• Hazard alert: Information issued to health
professionals about issues or deficiencies relating to
an implanted medical device or biological product.
You can search for recall
actions via this link at
www.tga.gov.au
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21. Pharmacovigilance Inspection Program
The TGA’s Pharmacovigilance Inspection Program (PVIP) has been
introduced to help sponsors meet pharmacovigilance obligations by:
• educating sponsors
on their
pharmacovigilance
requirements
• verifying Australian
sponsors’ compliance
with existing
requirements
• working with
sponsors to ensure
systems are
collecting current
information on the
safety and efficacy of
their medicines.
For more details visit:
www.tga.gov.au/pharmacovigilance-
inspection-program
22. Subscribe to the
TGA information
services to stay
up-to-date:
www.tga.gov.au
Receive information on:
• Safety alerts
• Recall actions
• Medicines Safety Update
• Medical Devices Safety Update
• Consultations
• Publications
• Scheduling
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23. Other education modules include:
regulate:Introduction to the TGA
Medicines
Biologicals
Devices
Good manufacturing practice
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