Regulatory medical writing is an integral part of Medical Communications, but is often overlooked. In simple terms, it involves writing of the documents required for the approval of drugs by the regulatory authorities.
https://www.cognibrain.com/regulatory-medical-writing/
TSDP emphasizes on understanding client’s requirements for drafting proposals for preparation of medico-marketing documents. To know more about medical writing training, visit: http://turacozskilldevelopment.org/
Medical writing is the art of creating a document that includes medical information in a readable language which is easily comprehended by the target audience. The target audience for medical writing varies and so is the style of medical writing.
https://www.cognibrain.com/medical-writing-answering-your-questions/
Regulatory requirements for drug approval in Saudi ArabiaSridhar S
Any drug after manufacture it should undergo the approval process under the the regulatory authority of the country to market the drug.
in this slides i have explained the requirements for approval and approval and approval procedure of the drug product in Saudi Arabia
Regulatory medical writing is an integral part of Medical Communications, but is often overlooked. In simple terms, it involves writing of the documents required for the approval of drugs by the regulatory authorities.
https://www.cognibrain.com/regulatory-medical-writing/
TSDP emphasizes on understanding client’s requirements for drafting proposals for preparation of medico-marketing documents. To know more about medical writing training, visit: http://turacozskilldevelopment.org/
Medical writing is the art of creating a document that includes medical information in a readable language which is easily comprehended by the target audience. The target audience for medical writing varies and so is the style of medical writing.
https://www.cognibrain.com/medical-writing-answering-your-questions/
Regulatory requirements for drug approval in Saudi ArabiaSridhar S
Any drug after manufacture it should undergo the approval process under the the regulatory authority of the country to market the drug.
in this slides i have explained the requirements for approval and approval and approval procedure of the drug product in Saudi Arabia
Insurance & compensation in clinical trialLikith `HV
PPT on insurance and compensation in clinical trial. Compensation formula. compensation guidelines, clinical trial related injury, SAE, serious adverse event, reporting of SAE and its timeline, compensation guidelines and formula for calculating the compensation
SAE REPORTING TIMELINE AND COMPENSATION 2019Shweta Lal
This presentation is based on New Drug and Clinical Trial Rule 2019 which was published in 19 march 2019. I have described chapter VI ( compensation) and Seventh Schedule including SAE reporting timeline in India.
Themedical writing services team at Cognibrain comes distinctively qualified to research, compile, write and edit a wide range of medical specialties and scientific areas that are required to support your content development efforts.
i-CME offers online Online Medical Writing training and scientific writing training. It includes consumer, scientific, publication, manuscript, medical marketing, SOP's and protocol writing.
For more details:
http://onlinemedicalwriting.com/
Clinical Research Associate (CRA) - A Growing Career Path in Biotechnology / ...SOCRA CCRP Certification
SOCRA study guide - ES’ SOCRA CCRP Exam Study Guide – A resource to help those who is preparing for the SOCRA Certified Clinical Research Professional (CCRP) certification.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Insurance & compensation in clinical trialLikith `HV
PPT on insurance and compensation in clinical trial. Compensation formula. compensation guidelines, clinical trial related injury, SAE, serious adverse event, reporting of SAE and its timeline, compensation guidelines and formula for calculating the compensation
SAE REPORTING TIMELINE AND COMPENSATION 2019Shweta Lal
This presentation is based on New Drug and Clinical Trial Rule 2019 which was published in 19 march 2019. I have described chapter VI ( compensation) and Seventh Schedule including SAE reporting timeline in India.
Themedical writing services team at Cognibrain comes distinctively qualified to research, compile, write and edit a wide range of medical specialties and scientific areas that are required to support your content development efforts.
i-CME offers online Online Medical Writing training and scientific writing training. It includes consumer, scientific, publication, manuscript, medical marketing, SOP's and protocol writing.
For more details:
http://onlinemedicalwriting.com/
Clinical Research Associate (CRA) - A Growing Career Path in Biotechnology / ...SOCRA CCRP Certification
SOCRA study guide - ES’ SOCRA CCRP Exam Study Guide – A resource to help those who is preparing for the SOCRA Certified Clinical Research Professional (CCRP) certification.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Academic Festival Executive Leadership Coaching Guest V1Temaltbia
Faculty Director leds panel with other Columbia Faculty focused on strategies for leveraging Executive Coaching for leadership effectiveness during 2nd Annual Academic Festival (April 24, 2010).
Medical Writing and the Technical WriterBill Dubie
At the April 2010 meeting of the Society for Technical Communication Northern New England Chapter, medical writer Bill Greuner described his transition from technical writer to medical writer, discussing what technical writers looking into this field should look for and how to prepare.
Canada Clinical Diagnostics Market Sample Report 2022 to 2030Insights10
Canada's clinical diagnostics is expected to witness significant growth from $3.9 Bn in 2022 to $4.9 Bn in 2030 with a CAGR of 3.1% for the year 2022-30.
Crossing the Valley of Death in Drug Discoveryszecola
The benefits of "Big Data" in health care will be undermined by the Valley of Death resulting from the FDA's drug approval process. The drug approval process should be changed as recommended herein.
Canada's clinical diagnostics is expected to witness significant growth from $3.9 Bn in 2022 to $4.9 Bn in 2030 with a CAGR of 3.1% for the year 2022-30. The main growth drivers of the Canadian clinical diagnostics market are growing awareness about early disease detection and the benefits of early treatment. Further, the increasing investments by the government in diagnostic services are responsible for the market growth.To get a detailed report, contact us at - info@insights10.com
What’s Next in US Payor Communications: The Impact of FDA's Proposed Guidance...Nathan White, CPC
The recent enactment of the 21st Century Cures Act has profound immediate and long-term implications for development and communication of HEOR/RWE in the US, particularly in relation to communications with payors about healthcare economic information (HCEI). In January, the FDA released draft guidance for public comment to outline its thinking around communication to payors of HCEI, but there are still unanswered questions to be addressed in the final guidance. Industry will need to quickly establish new policies and procedures to maintain compliance with the new regulations, especially in relation to OPDP submission requirements – a steep transition from a space that has largely been unregulated.
Managing National Health: An Overview of Metrics & OptionsDale Sanders
This is a presentation that I gave at the annual international healthcare conference hosted by the Cayman Islands government. It summarizes the international standards and frameworks for planning and managing the health of a nation. One of the most fun parts of a very fun career was the time that I spent working and living in the Cayman Islands and serving as the CIO of the national health system. The Cayman Islands national health system sat at the intersection of three very influential healthcare ecosystems-- the United States, United Kingdom, and the Pan-American Healthcare Organization. As a result, I was fortunate enough to learn from these international settings and contrast that to the US healthcare system. Other healthcare systems tend to benchmark themselves internationally more so than the United States, where we tend to benchmark ourselves internally. Unfortunately, those internal US benchmarks are the lowest in the developed world by almost every measure of national health.
New Product Planning in the Pharmaceutical IndustryAnthony Russell
Lecture presented in the Competitive Intelligence and Pricing course as part of the University of Southern California Master of Science in Healthcare Decision Analysis program. Presented on June 14, 2020 at USC via Zoom. The lectures gives an overview of what new product planning is in the pharmaceutical industry, what tools are used during new product evaluations, and the key elements of a new product business case. The lecture includes a couple of case studies to be worked on by the class.
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
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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
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.
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!
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
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
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
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
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1. Medical Writing in Canada Presented at AMWA National Conference October 25, 2008, Louisvile, KY Amanda Strong [email_address] 514.239.2736 www.medicalcommunications.ca
2.
3. Pharma in Canada Source: Industry Canada. Canadian pharmaceutical Industry Profile. http://strategis.ic.gc.ca/epic/site/lsg-pdsv.nsf/en/h_hn00021e.html
4. Pharma in Canada Source: 2005 drugstore and hospital purchases audit performed by IMS Health Top 10 leading pharmaceutical companies in Canada 3.2 552 Montreal Bristol-Myers Squibb 10 3.5 602 Montreal Merck Frosst 9 3.7 625 Quebec Sanofi-Aventis 8 3.8 647 Toronto Novartis 7 4.0 675 Montreal Wyeth 6 5.6 950 Toronto Apotex 5 5.8 996 Toronto GlaxoSmithKline 4 6.5 1,106 Toronto Johnson & Johnson 3 6.6 1,121 Montreal AstraZeneca 2 13.4 2,288 Montreal Pfizer 1 Market Share (%) Total Sales ($Millions) R&D Location Leading Companies Rank
7. Canadian Medical Writers Sectors of Employment of Medical Writers in Canada 10.2 ± 25.8 0.4 ± 2.1 Other 1.4 ± 4.6 4.3 ± 20.9 Non-governmental Organization 5.2 ± 11.5 0.2 ± 1.0 Governmental Organization 3.0 ± 9.7 4.3 ± 20.9 Research/Education Organization 6.2 ± 22.3 8.7 ± 28.8 Contract Research Organization 3.4 ± 7.9 4.3 ± 20.9 Healthcare Organization 22.9 ± 32.0 13.0 ± 34.4 Communication or Marketing 14.6 ± 26.4 12.4 ± 32.8 Journal or Publisher 1.7 ± 9.3 0 ± 0 Patient/Disease Association 1.3 ± 4.9 4.3 ± 20.9 Professional Association 24.5 ± 33.0 43.3 ± 50.4 Industry 5.2 ± 11.7 4.6 ± 18.9 Academia Freelance Employed
8. Canadian Medical Writers Yearly Income and Average Hours Worked per Week Source: 2008 AMWA Canada Salary Survey 26.2 – 33.8 37.1 – 40.2 95% CI 2, 45 30, 50 Min, Max 30.0 39.0 Median 30.0 ± 9.9 (22.5 ± 8.1 billable) 38.7 ± 3.7 Mean (± SD) Hours worked $48,223 – $76,740 $67,913 – $91,135 95% CI $1,000, $150,000 $40,000, $135,000 Min, Max $67,000 $75,000 Median $62,482 ± $36,044 $79,524 ± $25,508 Mean (± SD) Income Freelance Salary
The pharmaceutical industry is involved in producing prescription and non-prescription drugs, including biopharmaceuticals. More than 22 000 drug products are available in Canada and the pharmaceutical industry is one of the most profitable in Canada, ranked #8 worldwide in market sales with an 8% annual growth rate. Drug costs are the single largest healthcare cost in Canada, behind hospitals and ahead of physicians, and its proportion is increasing every year. In 2005, about bout 18% of total health expenditures were pharmaceutical purchases. Biopharmaceuticals are a growing segment of the pharmaceutical market. In contrast to traditional pharmaceuticals that are chemicals, biologics are made by using living biological systems to modify large molecules, like proteins and hormones.
Brand name drugs account for most sales in Canada (84% in 2005), most of which are developed and manufactured by foreign-owned multi-nationals like Merck-Frosst, Novartis, or Pfizer. The Canadian offices for most of these companies are located in the greater Montreal or Toronto areas. However biopharmaceutical companies tend to cluster in Montreal and Calgary. Brand-name companies are involved in the whole lifecycle of a drug, from development to market, and own (or license) the patents on a drug. Research and development (R&D) of a pharmaceutical is expensive and time-consuming. It typically takes between 10 to 15 years for a drug to reach market, at an estimated cost of $605 million USD for traditional chemical-based pharmaceuticals and $559 million USD for biopharmaceuticals (2005 costs). That does not include operating or marketing costs. Here are the top 10 leading pharmaceutical companies in Canada, according to a 2005 drugstore and hospital purchases audit performed by IMS Health:
In 2005, 14% of drugs sold in Canada were cardiovascular agents. This class includes drugs used to treat high blood pressure (hypertension), heart failure, arrhythmia and angina, as well as anticoagulants and similar medications. The next largest class of drug sales in Canada was the psychotherapeutics (10%). These are drugs used to treat mental illness, such as depression, anxiety, schizophrenia and bipolar disorder. Cholesterol agents represented 9% of drugs sold in Canada, followed by anti-spasmodics (drugs that reduce muscle spasms or cramping; 8%) and anti-cancer agents (7%). Here are the top 10 leading prescription drug (brand name products), according to a 2005 drugstore and hospital purchases audit performed by IMS Health. Keep in mind that these are 2005 figures. In the pharmaceutical industry, ‘market position’ of a brand can change fairly rapidly as new drugs are introduced into the marketplace and long-term adverse event profiles of existing drugs become known.
![Medical Writing in Canada Presented at AMWA National Conference October 25, 2008, Louisvile, KY Amanda Strong [email_address] 514.239.2736 www.medicalcommunications.ca](https://image.slidesharecdn.com/medicalwritingcanada-amwa2008-091015103244-phpapp01/85/Medical-Writing-Canada-1-320.jpg)
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