Fast track Designation is a designation for accelerated approval of drugs and medicines in US. Presentation contains brief view of this expedite program.
While the world is going through pandemic turmoil and regulatory agencies are under immense stress to approve newer pharmaceutical therapies to market. However, the classical/regular clinical trial is a hefty process hence alternative provisions like speed trials were explored for the early entry of drugs for emergency usage.
Outsourcing is a Cost-effective strategy when used properly and at present is gaining more and more importance. Here's a short presentation about the importance of outsourcing in Clinical research.
How can one regulatory program simultaneously benefit both blockbuster drugs and rare or neglected diseases? How can your company leverage the opportunities afforded by this program? This presentation walks you through the how’s and why’s of the FDA’s Priority Review Voucher program.
Fast track Designation is a designation for accelerated approval of drugs and medicines in US. Presentation contains brief view of this expedite program.
While the world is going through pandemic turmoil and regulatory agencies are under immense stress to approve newer pharmaceutical therapies to market. However, the classical/regular clinical trial is a hefty process hence alternative provisions like speed trials were explored for the early entry of drugs for emergency usage.
Outsourcing is a Cost-effective strategy when used properly and at present is gaining more and more importance. Here's a short presentation about the importance of outsourcing in Clinical research.
How can one regulatory program simultaneously benefit both blockbuster drugs and rare or neglected diseases? How can your company leverage the opportunities afforded by this program? This presentation walks you through the how’s and why’s of the FDA’s Priority Review Voucher program.
Presentation: New pathway for complementary medicinesTGA Australia
An overview of recommendation thirty-nine from the Review of Medicines and Medical Devices Regulation relating to improving access to evidence based listed complementary medicines.
Keynote presentation at the Drug Delivery Conference, sponsored by Pharmaceutical Education Associates, in June 2007, in San Diego. Talk focused on new drug regulatory issues, especially those arising under draft legislation that would eventually lead to the 2007 Food and Drug Administration Amendments Act (FDAAA).
Is your product or medical device FDA-friendly? Learn about how to get a safe and effective product into the market, confronting risk management, complaints, and remediation services.
Elizabeth Mansfield, PhD, discusses the FDA’s approach to regulation
of in vitro diagnostic tests.
Part of Dx2010, a workshop at MaRS focused on best practices and regulatory considerations for developing gene-based diagnostic and prognostic tests.
Investigational new drug application must be submitted after discovering a new drug and before beginning of clinical trials. Here given a brief note on the topic.The topics included are types of IND, criteria for application, Information in IND application, resources for IND application, laws.regulations, policies and procedures, IND forms and instructions, IND content requirements and review of IND
Complementary medicines MMDR reforms: Assessment pathwaysTGA Australia
An overview of the reform initiatives relevant to complementary medicines. Topics include the implementation of recommendations from the Review of Medicines and Medical Devices Regulation.
Part of the MaRS BioEntrepreneurship event series
Speaker: Wendy Hill, Gap Strategies
This event is available as an audio file:
http://www.marsdd.com/bioent/feb12
Presentation: What's trending in medicines regulation? A January 2017 reflectionTGA Australia
This presentation provides a local perspective on recent developments in the medical technology and pharmaceutical landscape, and the future of the TGA in a global context.
TGA presentation: Provisional approval pathway for prescription medicinesTGA Australia
This presentation provided an overview of some of the reform activities relevant to prescription, OTC and complementary medicines and implementation of recommendations from the Review of Medicines and Medical Devices Regulation including the content of the consultations on enhancements
Strategies to Increase Medical Affairs' Role in Health Outcomes Data Generati...Best Practices
With the shift toward evidence-based medicine and value-based pricing, many bio-pharmaceutical companies are transitioning their Health Economics and Outcomes Research (HEOR) function away from the Commercial organization to Medical Affairs. This has some major implications towards the interactions with key stakeholders, the way interactions are documented and the skill sets & activities that may be required. Development of strong health outcomes capabilities within Medical Affairs organizations requires an increase in that function’s involvement with health outcomes groups, development of field-based health outcomes capabilities, customization of health outcomes data by stakeholders and building real world data capabilities to generate and utilize health outcomes information.
Best Practices, LLC undertook this study to identify strategies to increase MA’s role in Health Outcomes data generation and utilization. Specifically, the study highlights the role of Medical Affairs function in HO activities, industry drivers and resource levels for HO groups, challenges of MA’s involvement in HO activities and strategies for effective HO data communication and utilization.
Download Full Report: http://bit.ly/2dGFAbz
Presentation: New pathway for complementary medicinesTGA Australia
An overview of recommendation thirty-nine from the Review of Medicines and Medical Devices Regulation relating to improving access to evidence based listed complementary medicines.
Keynote presentation at the Drug Delivery Conference, sponsored by Pharmaceutical Education Associates, in June 2007, in San Diego. Talk focused on new drug regulatory issues, especially those arising under draft legislation that would eventually lead to the 2007 Food and Drug Administration Amendments Act (FDAAA).
Is your product or medical device FDA-friendly? Learn about how to get a safe and effective product into the market, confronting risk management, complaints, and remediation services.
Elizabeth Mansfield, PhD, discusses the FDA’s approach to regulation
of in vitro diagnostic tests.
Part of Dx2010, a workshop at MaRS focused on best practices and regulatory considerations for developing gene-based diagnostic and prognostic tests.
Investigational new drug application must be submitted after discovering a new drug and before beginning of clinical trials. Here given a brief note on the topic.The topics included are types of IND, criteria for application, Information in IND application, resources for IND application, laws.regulations, policies and procedures, IND forms and instructions, IND content requirements and review of IND
Complementary medicines MMDR reforms: Assessment pathwaysTGA Australia
An overview of the reform initiatives relevant to complementary medicines. Topics include the implementation of recommendations from the Review of Medicines and Medical Devices Regulation.
Part of the MaRS BioEntrepreneurship event series
Speaker: Wendy Hill, Gap Strategies
This event is available as an audio file:
http://www.marsdd.com/bioent/feb12
Presentation: What's trending in medicines regulation? A January 2017 reflectionTGA Australia
This presentation provides a local perspective on recent developments in the medical technology and pharmaceutical landscape, and the future of the TGA in a global context.
TGA presentation: Provisional approval pathway for prescription medicinesTGA Australia
This presentation provided an overview of some of the reform activities relevant to prescription, OTC and complementary medicines and implementation of recommendations from the Review of Medicines and Medical Devices Regulation including the content of the consultations on enhancements
Strategies to Increase Medical Affairs' Role in Health Outcomes Data Generati...Best Practices
With the shift toward evidence-based medicine and value-based pricing, many bio-pharmaceutical companies are transitioning their Health Economics and Outcomes Research (HEOR) function away from the Commercial organization to Medical Affairs. This has some major implications towards the interactions with key stakeholders, the way interactions are documented and the skill sets & activities that may be required. Development of strong health outcomes capabilities within Medical Affairs organizations requires an increase in that function’s involvement with health outcomes groups, development of field-based health outcomes capabilities, customization of health outcomes data by stakeholders and building real world data capabilities to generate and utilize health outcomes information.
Best Practices, LLC undertook this study to identify strategies to increase MA’s role in Health Outcomes data generation and utilization. Specifically, the study highlights the role of Medical Affairs function in HO activities, industry drivers and resource levels for HO groups, challenges of MA’s involvement in HO activities and strategies for effective HO data communication and utilization.
Download Full Report: http://bit.ly/2dGFAbz
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
Final navigating multiple clinical trial requirements for the usBhaswat Chakraborty
The title of the given topic mainly asks for technical, ethical and strategic aspects of multiple clinical trials that would result in a successful approval of an NDA by the US FDA. Other than Phase I studies aimed at safety and tolerance in healthy subjects, usually one or two exploratory (Phase II) and multiple confirmatory (Phase III) studies are required. Studies in Phase III need to be designed to confirm the findings in Phase II that a drug is safe and effective for use in the intended indication and recipient population. These studies provide an adequate basis for marketing approval. All clinical studies giving evidence of efficacy & safety must be adequate and well-controlled investigations entailing a valid comparison to a control and an accurate quantitative assessment of the drug’s effect. In rare situations, only a single, adequate and well-controlled study of a specific new use (that can be supported by information from other related adequate and well-controlled studies) will suffice for approval. However, when a single study is used, there should be hardly any room for study imperfections or non-supportive information.
In addition to addressing the strategies for multiple clinical trial requirements, the speaker would also discuss the documentation requirements and best practice on conducting effective clinical trials for the US to establish a roadmap for success and also a swift approval. Both documentation and best practices must contain a complete, entirely accurate, representation of study plans, conduct and outcomes. Incompleteness, lack of clarity, unmentioned deviation from prospectively planned analyses, or an inadequate description of how critical endpoint judgments or assessments were made, are seen to be common problems.
Regulatory Update Panel
An overview of all Health Canada policies supporting access to Drugs for Rare Diseases, including regulatory pathways and support for innovation, patient engagement, Special Access Programs, aligned HC/CADTH/INESSS, international harmonization, post-market monitoring, support for patient registries, current status and relevance of biosimilars for rare disease patients
Rare Disease Day Conference 2020 March 9-10
Rare diseases are characterized by a broad diversity of disorders and symptoms that vary not only from disease to disease but also from patient to patient suffering from the same disease. Rare diseases can be chronic, progressive, degenerative, and often life-threatening. Given the small patient populations, traditional development pathways may not be relevant or necessary, requiring novel and innovative approaches. From a market access perspective, lack of comparative effectiveness and long-term outcomes data can lead to delays in reimbursement and significant post-launch evidence generation commitments. Treatment costs and patient benefits may not be matched over time giving rise to difficulties with assessing the value and establishing the necessary funding pathways. VCLS is at the forefront of designing new strategies to bring effective and timely treatments to patients in these high unmet need rare disease areas.
This presentation provides an outline for smarter orphan drug development through:
• Integrating development approach
• Reducing cost and time
• Maximizing patient access
Alternative Approaches to FDA Approval for Drug and Device FirmsMichael Swit
Webinar sponsored by Compliance2Go focusing on different ways that drug and medical device firms can secure approval of products outside of traditional approaches. Presentation covers:
* accelerated approval
* fast track drugs
* priority review
* special 510(k)
* abbreviated 510(k)
Presentation to the San Diego Regulatory Affairs Network (SDRAN) on the various approaches to drug and device approval/marketing that differ from standard method, including:
* accelerated approval
* fast track drugs
* priority review
* special 510(k)
* abbreviated 510(k)
Beyond the Horizon: Navigating Late Phase Clinical TrialsRuchi Vahi
Late phase clinical trials are a crucial step in the drug development process, providing valuable information on a drug's safety and efficacy in a larger patient population. Designing and conducting these trials requires careful planning and execution, as well as adherence to ethical and regulatory guidelines.
Visit us: https://mprex.in/project/late-phase-clinical-trials-and-research/
This presentation provides an overview of proposals for implementation of several reform initiatives relevant to prescription medicines, including expedited pathways for registration, enhanced post-market monitoring, variations to registered medicines, work sharing with comparable overseas regulators, the use of overseas assessment reports, and reforms to the orphan drug programs. The information session was held ahead of formal public consultations to provide an early view of the reform proposals to those stakeholders who will be most directly involved in the design of the new regulatory arrangements.
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.
Get Your Development Program Started on the Right FootBrook White, PMP
You think you have a potential pharmaceutical or biotechnology product based on animal or in vitro data—what is the next step? Two documents you need at an early stage are the Target Product Profile (TPP) which defines expectations for your potential medicine and an Integrated Product Development Plan (IPDP) which describes the activities required through approval of your marketing application.
Presentation: Spotlight on prescription medicines reformsTGA Australia
An overview of initiatives arising from the Review of Medicines and Medical Devices Regulation relevant to prescription medicines as well as orphan drugs and developments for eCTD and the new MedSearch app.
Supply planning is broken. Modern business challenges have reduced forecast accuracy, increased the effect of the bullwhip, and pushed inventories into a permanent state of imbalance.
Learn what MIT revealed at the Gartner Supply Chain Conference at https://o8supplychain.com/supply-planning-featured-case-studies/why-a-forecast-is-not-a-plan-and-what-mit-research-reveals-ppc/
Improving Supply Planning - A Demand Driven JourneyBen Bradley
Download the complete case study at https://o8supplychain.com/british-telecom-demand-driven-lp
Learn how British Telecom found out that there is a ‘different way’ to improve the accuracy of their demand forecast while realizing the following benefits:
Supply chain ‘de-risked’ from forecast accuracy
Strong positive impact on cash flow and ROCE
Higher service levels and shortened customer response times
Overall inventory reduction typically between 20%-30% across LoBs
Release of supply chain capacity by not producing, buying and storing the wrong stuff
Cost reduction – lower planning effort with improved outcomes – more stable signals to suppliers – lower expedite costs
Supply Planning - Case Study - Boots Contract Manufacturing and Orchestr8Ben Bradley
Get a copy of the deck at https://o8supplychain.com/how-o8-manages-supply-planning-for-bcm/
Learn how one company avoided pitfalls normally associated with forecast-driven production plans that drive up costly stock levels and result in continual rework.
By moving away from an MRP forecast “Push” to a “Pull” based approach using DDMRPII™, they were able to:
• deliver the required level of customer service with minimal stocks at minimal cost
* Reduce the number of stock-outs
* Minimize excess stocks & obsolescence
* Minimize administration, handling & transport costs
* Allow the supply chain to cope with uncertainty
and more
End-to-end supply planning and execution with O8 DDMRPII™Ben Bradley
Get a copy of the deck today. Download the deck. https://o8supplychain.com/ddmrp-vs-mrp/
Learn the difference between O8's DDMRPII™ and DRP/ MRP. Learn how improved supply planning can help you achieve key inventory management objectives:
*To deliver 99% fill rate and service level with minimal stocks at minimal cost
*Reduce the number of stock-outs
*Minimise excess stocks & obsolescence
*Minimise administration, handling & transport costs
*Reduce number of exception messages that drive non-value added activity
*Allow business to focus on high value add processes and decision making
*Minimise the reliance on inaccurate forecasts
*Allow the supply chain to cope with uncertainty
Simple, Stupid CRM segmentation model for professional services firmsBen Bradley
For professional services firms jumping into CRM implementations (and trying to get some marketing and selling done at the same time), this deck explains a simple, stupid method for getting started quickly. For more information or to request a copy of this deck, visit www.maconraine.com - Macon Raine is a Chicago based b2b marketing agency or simply email ben bradley @ ben at maconraine.com
Are processes masquerading as projects hurting your businessBen Bradley
Not long ago, a significant amount of the work done within companies was simpler and a higher percentage of it tended to be fairly repetitive. Today, work featuring unstructured decision-making—knowledge work—accounts for 25% to 50% of all work, and this percentage is growing. The challenge is that while the work needed today has changed fairly radically, technology solutions had not adapted to the new environment—business process management (BPM) and project management solutions are really good at managing a predictable, repetitive world, but these solutions are not well-suited to business scenarios containing a lot of uncertainty and requiring unstructured decision-making in order to reach positive outcomes. Work-Relay is a powerful, easy-to-use platform for designing and deploying business processes of any level of complexity on the Salesforce.com platform. Includes the full spectrum of projects and processes, from fully automated to ad hoc.
Activity based billing for SugarCRM - Transverse LLC presentation from SUGARC...Ben Bradley
For businesses that want to take their subscription or recurring billing to the next level, TRACT from Transverse gives your CRM the power to use subscriptions to increase consumption by tailoring pricing to customers’ usage patterns and preferences.
TRACT includes the following features/functions:
Real-Time Rating Engines
Dashboard/Analytics
Connected Devices
Subscription Management
Billing/Payments
Integration
Product Catalogs
To grow subscription revenue, TRACT has been developed with one thing in mind: empower business people to define the “what ifs” that will drive new product and service development, and to maintain rules on an ongoing basis as the products and services evolve.
In fact, with TRACT, business people in product development, marketing and finance can develop, deploy, maintain, change and decommission services. TRACT boasts a rules-based rating engine that uses a common spreadsheet interface to define rate plans. This approach makes the creation of rating rules one that is already very familiar to business people already using Microsoft Office, NetSuite and other business applications. It is designed to simplify and automate the task of defining complex usage types through a rules-based system that offers straightforward configurations.
TRACT is the only billing product or service that is truly usage-aware without forcing customers to write code or build external systems to handle usage.
Template content marketing plan with an emphasis on cross selling, social med...Ben Bradley
Macon Raine helps companies with outbound, inbound and social campaigns and content that drive demand, prospect inquiries and web visits. We give your prospects reasons to request your content and consider your solutions so that you can woo them with value and keep them coming back until they are ready to be sold.
SaaS Billing Essentials - how to add products with subscription, usage or a...Ben Bradley
Overview that explains how subscription billing platforms work with CRM and pass data to ERP and GL systems. How to add subscription billing and activity pricing to CRM systems to support new business models with usage, activities and entitlements. Tractbilling.com
www.tractbilling.com - Understanding critical processes in subscription + act...Ben Bradley
This document explains the critical processes in deploying a subscription + activity billing model.
TRACT, from Transverse LCC, is the all-in-one activity, rating and subscription billing platform that can bill for anything.
SaaS, cloud, MSP, ISVs, telcos or wireless providers with activity-based business models use TRACT’s pricing levers to rapidly build and evolve any business model: if it can be metered or measured, TRACT can bill for it.
Learn more at www.tractbilling.com.
Build Better Customer Relationships with Subscription Options Ben Bradley
A webinar from TRACTBIlling that explains how to offer subscription options to customers, pitfalls to avoid and economics of various subscription business models.
Businesses that implement subscription billing will eventually go through the same trials, tribulations, proliferation of service offerings and evolution of price plans as experienced by telecommunication service providers. To grow and identify new sources of revenue and compete effectively, these companies will need Dynamic Revenue Management - a single system that can handle quotes, account creation, orders, pricing, payments, settlement, subscriber management, analytics, and business intelligence.
TRACT is an integrated billing system that delivers Dynamic Revenue Management seamlessly from the cloud, on demand. TRACT helps companies identify new sources of revenue through improved billing AND increase sales by dynamically tailoring pricing packages to customers’ usage patterns and preferences. TRACT integrates quickly and speeds the launch of new offers, promotions and bundles.
Why offer subscription options to your customers?
Create multiple price plans
Inject relevant promotions
Longer-term, more predictablerevenues
Market Differentiation!
Customer convenience
Attract a new breed of customer
Build relationships with customers
Understand customer buying behaviors for smarter product management
Available on the web at www.tractbilling.com
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
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
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.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
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.
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
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
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
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
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stockrebeccabio
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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
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. Expedited Drug Approval Classifications
• Fast Track
• Accelerated Approval
• Priority Review
• Breakthrough Therapy
3. Fast Track Designation
• Drug must be intended to treat a serious condition
• May address an unmet medical need
• Fast Track designation request can be submitted at any time during drug development process
• Supporting data can be clinical or nonclinical
• Earlier and more frequent communication with the FDA during development
• Rolling review of application
• Fast Track designation may be withdrawn if drug no longer meets qualifying criteria
4. Accelerated Approval Designation
• Drug must treat a serious condition
• Provide significant improvement in safety or effectiveness when compared to drugs currently on
the market
• May use surrogate endpoints to demonstrate clinical benefit
• Approval is granted on conditional basis – post-approval trials are necessary
• Earlier and more frequent communication with the FDA during development
• Application is submitted in one package
• Drug is subjected to expedited withdraw
5. Priority Review
• Drug must treat a serious condition
• Provide significant improvement in safety or effectiveness when
compared to drugs currently on the market
• Drug review process is shortened to 6 months
6. Breakthrough Therapy
• Drug must treat a serious condition
• Provide significant improvement in safety or effectiveness when compared to drugs currently on
the market
• Supporting data must be clinical
• Intensive FDA guidance and involvement throughout development process involving senior FDA
officials
• Rolling review of application
• Although clinical data is required, an all hands on deck approach is taken to get the drug to
market
7. Often Dual Designations
• A drug often qualifies for two designations. For example, both
Breakthrough Therapy and Accelerated Approval designations are
granted to qualifying drugs
8. Traditional Prescription Drug Development
• On average, 12-year development timeline*
• Including expenditures and opportunity costs, an average of ~$2.6 billion to
bring a drug to market*
*Tufts Center for the Study of Drug Development (CSDD) report
9. Expedited Approval Drugs
• Expedited drug development timelines vary
• Chemistry, Manufacturing and Controls (CMC) data often needs to be developed in about
half the time of the traditional development process
• Patient safety and product supply cannot be compromised
• Analytical methods creation and product and process characterization must be started
earlier in the development process
• Some CMC activities may be incomplete at launch
10. 9 Approaches for Managing Expedited
Approval
#1
Open and transparent communication with the FDA throughout the
entire approval and post-market process. The pharmaceutical company
mindset of not wanting to learn certain information for fear of needing
to revalidate based on those discoveries has no place in this new
reality. New information will be learned pre- and post-launch, and
amendments will need to be filed.
11. 9 Approaches for Managing Expedited
Approval
#2
Additional stability data amendments will likely need to be filed during
the review process and in some cases post-market. This approach is
required given that less data will be available at submission due to
compressed timeframes.
12. 9 Approaches for Managing Expedited
Approval
#3
Launch commercial process with limited experience and optimize
post-approval–the classic three runs is not the guiding force within this
construct. The level of flexibility regulators will extend is determined
for each specific product. Factors taken into consideration include:
riskiness of product characteristics, seriousness of the condition and
medical need, complexity of manufacturing processes, state of the
innovator’s quality system and merits of the innovator’s risk-based
quality assessment including Critical Quality Attributes (CQA).
13. 9 Approaches for Managing Expedited
Approval
#4
Novel statistical models and approaches will need to be applied in
many cases. Representative samples and assays for these models will
likely need to be acquired from sources, like prior knowledge and use
of comparability protocols. Also, determination of the appropriate use
of stability data from representative pilot scale lots will be required.
14. 9 Approaches for Managing Expedited
Approval
#5
Manufacturers should freely acknowledge where data is limited,
demonstrate that the missing data pose no risk to patient safety or
product supply and outline post-market strategy for acquiring the
missing data. Conversations with the FDA are clearly required for
successful outcomes here.
15. 9 Approaches for Managing Expedited
Approval
#6
Focus on patient safety and reliable supply of quality product at
launch, not process optimization. In addition, begin critical product
attributes and process characterization work much earlier than a
typical pharmaceutical development process. In many cases, consider
broader product quality ranges for non-Critical Quality Attributes until
further manufacturing experience is acquired post-approval.
16. 9 Approaches for Managing Expedited
Approval
#7
Enhance analytical methods and understanding to offset more limited
process understanding and to support future comparability work.
Extremely important, involve commercial Quality Control
representatives in the development assay design.
17. 9 Approaches for Managing Expedited
Approval
#8
Some CMC activities may be incomplete at launch. Incomplete
processes could include: Process Validation, stability studies on
commercial product, manufacturing scale/tech transfer data and
complete control system data.
18. 9 Approaches for Managing Expedited
Approval
#9
A post-approval product lifecycle management plan is a must, and it
needs to be included in the filing to support deferred CMC activities.
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