This presentation was delivered to a webinar sponsored by Zinc Ahead on May 21, 2015, and provided an update about the current state of guidance from the FDA on the appropriate use of social media by prescription product manufacturers.
The Other Agency: An introduction to Pharma MarketingDale Cooke
This presentation helps people understand FDA's regulation of the marketing and promotion of prescription products. Included are the most prominent regulations that promotion of prescription products must meet.
This presentation covers the essential concept of ensuring all promotional communications are on label and the safe harbors established by FDA for disseminating off-label information compliantly.
I delivered this presentation at the DTC National Conference in Washington DC. The presentation highlights the importance of mobile for people making decisions about their health and discusses how to present information about FDA-regulated products in this important channel.
Compliant Promotion in an On-demand WorldDale Cooke
The Internet is now the premier source of healthcare information for physicians and consumers alike. Consequently, FDA-regulated companies have been leveraging it in various ways, but compliance has proven challenging and confusing for companies not accustomed to digital tactics.
* Recent FDA enforcement actions that command the attention of anyone considering digital communication tactics
* Trends in digital media consumption and their impact on advertising effectiveness
* FDA’s 2009 Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion
* FDA’s 2011 Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications
*Some red flags guaranteed to draw FDA’s ire
* The latest on FDA social media guidance
With the explosion of social media and its growing importance, it’s critical for those in the pharmaceutical industry to understand how to leverage social networks compliantly to see positive results and minimize risk. If, and when, the FDA guidance on social media is final, questions will remain. This presentation helps the audience incorporate the latest social media technologies into acceptable and successful communications and marketing plans. Focus is given to regulatory requirements, types of communications, responsiveness, and dealing with adverse events.
Search engines are the gateway to the Internet for most people, and FDA has a lengthy history of taking enforcement against companies for inappropriate promotion of prescription drugs via this vital tactic. This presentation from DIA's 2021 ad-promo conference was updated with the latest enforcement.
This presentation was delivered to a webinar sponsored by Zinc Ahead on May 21, 2015, and provided an update about the current state of guidance from the FDA on the appropriate use of social media by prescription product manufacturers.
The Other Agency: An introduction to Pharma MarketingDale Cooke
This presentation helps people understand FDA's regulation of the marketing and promotion of prescription products. Included are the most prominent regulations that promotion of prescription products must meet.
This presentation covers the essential concept of ensuring all promotional communications are on label and the safe harbors established by FDA for disseminating off-label information compliantly.
I delivered this presentation at the DTC National Conference in Washington DC. The presentation highlights the importance of mobile for people making decisions about their health and discusses how to present information about FDA-regulated products in this important channel.
Compliant Promotion in an On-demand WorldDale Cooke
The Internet is now the premier source of healthcare information for physicians and consumers alike. Consequently, FDA-regulated companies have been leveraging it in various ways, but compliance has proven challenging and confusing for companies not accustomed to digital tactics.
* Recent FDA enforcement actions that command the attention of anyone considering digital communication tactics
* Trends in digital media consumption and their impact on advertising effectiveness
* FDA’s 2009 Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion
* FDA’s 2011 Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications
*Some red flags guaranteed to draw FDA’s ire
* The latest on FDA social media guidance
With the explosion of social media and its growing importance, it’s critical for those in the pharmaceutical industry to understand how to leverage social networks compliantly to see positive results and minimize risk. If, and when, the FDA guidance on social media is final, questions will remain. This presentation helps the audience incorporate the latest social media technologies into acceptable and successful communications and marketing plans. Focus is given to regulatory requirements, types of communications, responsiveness, and dealing with adverse events.
Search engines are the gateway to the Internet for most people, and FDA has a lengthy history of taking enforcement against companies for inappropriate promotion of prescription drugs via this vital tactic. This presentation from DIA's 2021 ad-promo conference was updated with the latest enforcement.
This presentation looks at some of the unique considerations in developing mobile programs, especially apps. A significant amount of the presentation is dedicated to elucidating and expanding on the FDA's recently finalized guidance regarding mobile medical apps.
DIA 2014 Marketing Pharmaceuticals Conf Marketing in Age of ObamaDale Cooke
This is my portion of the session I led at the DIA 2014 Marketing Pharmaceuticals Conference about the impact of some of the recent legislative changes on people responsible for marketing pharmaceuticals in the United States.
Regulatory Considerations in Mobile ProgramsDale Cooke
This presentation looks at some of the unique considerations in developing mobile programs, especially mobile apps. A significant amount of the presentation is dedicated to elucidating and expanding on the FDA's recently finalized guidance regarding mobile medical apps. Topics covered include:
* FDA’s finalized Mobile Medical Applications—Guidance for Industry and Food and Drug Administration Staff
* Determination of whether a mobile app is a medical device subject to FDA enforcement action
* Scope of FDA’s regulatory discretion regarding mobile apps
* FDA’s conflicting guidance on dosage apps
* How to meet key requirements of promotional labeling in mobile programs
* The growing area of mobile apps as promotional messaging platforms
This presentation has appeal for anyone interested in adopting mobile tactics, whether that interest is in developing medical devices or making use of mobile tactics to promote pharmaceuticals or biologics.
The framework flow chart shown in this presentation is available here: http://ow.ly/qMxse
DIA Marketing Pharmaceuticals 2015 Leveraging Innovative TechnologiesDale Cooke
This is the slide deck I used to introduce a session on how sponsors of prescription drugs, biologics, and medical devices can take advantage of the newer means that both consumers and healthcare professionals are using to access information, while remaining compliant with FDA regulations.
Building a link between ectd and xevmpdQdossier B.V.
Describing the role of XEVMPD/ IDMP in context of the regulatory environment and explaining the link with information managed within the eCTD and under GMP.
ISO IDMP: Practical considerations from XEVMPD experienceQdossier B.V.
ISO IDMP (Identification of Medicinal Products) is coming! What lessons can we learn from our practical exprience with XEVMPD in preparation for IDMP? Topics include data cleaning, managing inconsistencies across product registrations and countries and controlled vocabularies
Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for S...Michael Swit
Supporting Materials for Michael Swit's Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Small Business Development Center (SBDC) @ UCI Applied Innovation
Latest Developments in and the Future of the Regulatory Landscape for Approv...Michael Swit
Presentation on "Latest Developments in and the Future of the
Regulatory Landscape for Approving Treatments
for Orphan and Rare Diseases," given at the Orphan Drugs & Rare Diseases -- 2018 Americas West Coast Conference.
June 25, 2018. San Diego, CA.
Companyprofilesandconferences.com glad to promote a new report on "Digna Biotech, S.L. - Product Pipeline Analysis" which are focuses on the development and commercialization of robust clinical therapeutic candidates through partnerships with pharmaceutical companies.
PhillyCooke eCTD Submissions for Ad-PromoDale Cooke
This presentation was initially delivered at the NJ/NY RAPS chapter on November 19, 2015. It reviews the FDA guidance on providing ad-promo submissions in electronic and print formats, explains the complex nature of the guidance and its scope, and includes the latest from FDA on how the guidance is being implemented.
The Importance of Social Media for PharmaDale Cooke
These slides were used for the introductory remarks for the FDAnews Social Media Regulatory Affairs Summit June 24-25, 2015. The intention was to motivate the need for companies to engage in social media and to address some of the topics that are most difficult for pharma to address.
This presentation looks at some of the unique considerations in developing mobile programs, especially apps. A significant amount of the presentation is dedicated to elucidating and expanding on the FDA's recently finalized guidance regarding mobile medical apps.
DIA 2014 Marketing Pharmaceuticals Conf Marketing in Age of ObamaDale Cooke
This is my portion of the session I led at the DIA 2014 Marketing Pharmaceuticals Conference about the impact of some of the recent legislative changes on people responsible for marketing pharmaceuticals in the United States.
Regulatory Considerations in Mobile ProgramsDale Cooke
This presentation looks at some of the unique considerations in developing mobile programs, especially mobile apps. A significant amount of the presentation is dedicated to elucidating and expanding on the FDA's recently finalized guidance regarding mobile medical apps. Topics covered include:
* FDA’s finalized Mobile Medical Applications—Guidance for Industry and Food and Drug Administration Staff
* Determination of whether a mobile app is a medical device subject to FDA enforcement action
* Scope of FDA’s regulatory discretion regarding mobile apps
* FDA’s conflicting guidance on dosage apps
* How to meet key requirements of promotional labeling in mobile programs
* The growing area of mobile apps as promotional messaging platforms
This presentation has appeal for anyone interested in adopting mobile tactics, whether that interest is in developing medical devices or making use of mobile tactics to promote pharmaceuticals or biologics.
The framework flow chart shown in this presentation is available here: http://ow.ly/qMxse
DIA Marketing Pharmaceuticals 2015 Leveraging Innovative TechnologiesDale Cooke
This is the slide deck I used to introduce a session on how sponsors of prescription drugs, biologics, and medical devices can take advantage of the newer means that both consumers and healthcare professionals are using to access information, while remaining compliant with FDA regulations.
Building a link between ectd and xevmpdQdossier B.V.
Describing the role of XEVMPD/ IDMP in context of the regulatory environment and explaining the link with information managed within the eCTD and under GMP.
ISO IDMP: Practical considerations from XEVMPD experienceQdossier B.V.
ISO IDMP (Identification of Medicinal Products) is coming! What lessons can we learn from our practical exprience with XEVMPD in preparation for IDMP? Topics include data cleaning, managing inconsistencies across product registrations and countries and controlled vocabularies
Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for S...Michael Swit
Supporting Materials for Michael Swit's Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Small Business Development Center (SBDC) @ UCI Applied Innovation
Latest Developments in and the Future of the Regulatory Landscape for Approv...Michael Swit
Presentation on "Latest Developments in and the Future of the
Regulatory Landscape for Approving Treatments
for Orphan and Rare Diseases," given at the Orphan Drugs & Rare Diseases -- 2018 Americas West Coast Conference.
June 25, 2018. San Diego, CA.
Companyprofilesandconferences.com glad to promote a new report on "Digna Biotech, S.L. - Product Pipeline Analysis" which are focuses on the development and commercialization of robust clinical therapeutic candidates through partnerships with pharmaceutical companies.
PhillyCooke eCTD Submissions for Ad-PromoDale Cooke
This presentation was initially delivered at the NJ/NY RAPS chapter on November 19, 2015. It reviews the FDA guidance on providing ad-promo submissions in electronic and print formats, explains the complex nature of the guidance and its scope, and includes the latest from FDA on how the guidance is being implemented.
The Importance of Social Media for PharmaDale Cooke
These slides were used for the introductory remarks for the FDAnews Social Media Regulatory Affairs Summit June 24-25, 2015. The intention was to motivate the need for companies to engage in social media and to address some of the topics that are most difficult for pharma to address.
Pharmaceutical companies have often been uncertain about how to meet their regulatory obligations while engaging in the new social media forums favored by consumers and physicians alike. FDA has released its first guidance addressing this topic since its 2009 hearings on the subject. The guidance addresses how sponsors can fulfill their requirement to file all material at the time of first use (the 2253 requirement) while engaging in real-time conversations.
This presentation examines key aspects of the guidance including:
* Status of user-generated content (UGC) and companies' reporting obligation for UGC
* Ability to meet 2253 filing requirements in the context of real-time conversations
* Implications of the guidance for filing online promotional materials other than social media
* Some open questions left unanswered by the guidance
This deck was presented at the 2013 Food & Drug Law Institute's Advertising & Promotion conference. I provided advice to people responsible for the selection and/or upgrade of electronic promotional review systems used in the review and approval of marketing materials for prescription products.
This regulatory framework flow chart is intended to help regulatory professionals and healthcare marketers apply the recent FDA guidance on mobile medical apps to any specific tactic. Following this simple procedure will help determine what regulatory requirements apply to any mobile initiative.
To receive a high-res version of this flow chart, fill out the Get in Touch form.
Pharmaceutical companies and SEO search results complianceMarcos Richardson
This paper looks at two search components (from an optimisation perspective and a pharama compliance perspective) that are publicly visible in search engine results: the ‘Title Tag’ and the ‘Description Tag’.
Search results are important because they are the first piece of information a person sees before clicking and entering a web property and should comply with FDA and PMCPA regulations.
Navigating FDA’s Social Media Guidelines for Medical Devices.pdfdnyaneshwarivedpatha1
Ensuring Regulatory Compliance and Monitoring in Medical Device Marketing
Compliance and Monitoring
FDA’s Stance on Continued Monitoring of Third-Party Websites and Social Media Platforms
The FDA emphasizes the importance of continued monitoring of third-party websites and social media platforms by medical device companies. This monitoring helps ensure that information related to their products remains accurate, up-to-date, and compliant with regulatory guidelines. Companies are responsible for actively monitoring user-generated content and addressing any misleading or inaccurate information promptly.
Non-Objection to Voluntary Corrections Meeting FDA’s Recommendations
The FDA encourages voluntary corrections by medical device companies to address misinformation or inaccuracies in their marketing materials. When companies take proactive steps to correct such information in line with FDA’s recommendations, the agency generally does not object to these corrective actions. This reflects a collaborative approach between regulatory authorities and industry stakeholders to uphold transparency and accuracy in marketing communications.
Reminder for Companies to Comply with Applicable Regulatory Requirements in Corrective Actions
Medical device companies must ensure that their corrective actions comply with all applicable regulatory requirements set forth by the FDA. This includes providing truthful and non-misleading information, adhering to labeling guidelines, and disclosing affiliations or relationships related to corrective information. Compliance with these requirements is essential to maintain ethical standards and regulatory compliance in marketing practices.
Recommendation for Companies to Maintain Records for Potential FDA Inquiries
As part of regulatory compliance, companies are advised to maintain detailed records of their marketing activities, corrective actions, and communications related to their medical devices. These records serve as evidence of compliance with FDA guidelines and can be valuable in addressing potential inquiries or audits by the FDA. Proper record-keeping demonstrates transparency, accountability, and a commitment to regulatory compliance within the medical device industry.
By adhering to these compliance and monitoring practices, medical device companies can uphold regulatory standards, address misinformation effectively, and maintain trust and credibility among consumers and regulatory authorities alike.
Navigating FDA Guidelines: Best Practices for Medical Device Advertising
Conclusion and Recommendations
Recap of Key Points from FDA’s Proposed Guidelines and Relevant Regulations
Throughout this discussion, we’ve explored the FDA’s proposed guidelines and regulations concerning medical device advertising on social media platforms. Key points include the importance of accurate and balanced communication of benefits and risks, addressing misinformation, and complying with FDA requirements for promotional
Performing Competitive Intelligence in a Pharmaceutical CompanyAnthony Russell
Workshop 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 Nov 4, 2018 at USC. The workshop gives an overview of what competitive intelligence is and how it is done in pharmaceutical companies. The workshop includes a couple of non-pharmaceutical exercises to help students learn how to write key intelligence questions and to work through a market simulation exercise. The workshop ends with a discussion on the various career pathways available within the competitive intelligence field.
In late 2011, the FDA released a document addressing how the pharmaceutical industry can and should respond to requests about off-label drug usage. This POV provides more information about the guidance document, highlights the key issues, and offers use cases to consider in the digital realm.
FDA Warning Letters: Dr. Reddy's Labs, January 2012RTC
The FDA recently released a warning letter to Dr. Reddy’s Laboratories’ for the HCP site for their product Fondaparinux. The website was cited for failing to prominently display the boxed warning in both the copy and navigation. This POV, from RTC's Digital Integration and Innovation team, gives more background on the FDA warning and discusses the implications for drug companies and marketers.
New FDA Social Media Guidelines 2014: Star Group AnalysisJoshua Spiegel
What does the recent draft guidance from the FDA for social media mean for Pharma brands? Find out what Star Life Sciences thinks, then visit us at starlifebrands.com to see more articles with our thinking.
You're driving down the highway, when suddenly you spot a police officer or a state trooper in your rearview mirror. You're driving the speed limit; your tags are up-to-date, yet you suddenly feel guilty – like you've done something wrong.
This is how the FDA makes us feel when it comes to running direct-to-consumer (DTC) advertising for medical devices and pharmaceuticals. More often than not, you aren't doing anything wrong. But your anxiety levels run high as soon as you step on the gas.
Opportunities of BDS in Pharmaceutical Industries.pptxDr. Manoj Kumbhare
India is the second-largest pharmaceutical market in Asia. ... A BDS graduate can have various job roles available in this sector: Principal Investigator, Co-investigator, Medical Advisor, Drug Developer, Regulatory Affairs Manager or even a Clinical Research Physician.
Career opportunities in the clinical research field are many and varied, with employment settings ranging from pharmaceutical and biotechnology, to medical device companies, contract research organizations, hospitals, educational institutions, independent contractors and more.
Many professionals with a strong science or healthcare related background — such as nurses, pharmacists, medical technologists, physicians and more — are well-positioned to join the clinical research field. Here are 10 career paths in the field.
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.
5th Biosimilars Congregation 2014
10th September 2014, Kohinoor Continental Hotel, Mumbai, India
“Uniting industry leaders to analyse advanced commercial developments & to identify successful management strategies of Biosimilars”
Marketing FDA Regulated Products Through Social MediaAnita Anzo
Scheduled On Wednesday, October 9, 2013 at 01:00 PM EDT
Duration: 90 minutes
This webinar is recorded
visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1103
Similar to Current State of Paid Search Marketing (20)
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
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.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
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
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
- 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
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
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!
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Surgical Site Infections, pathophysiology, and prevention.pptx
Current State of Paid Search Marketing
1. Current State of
Paid Search Marketing
!
!
!
!
!
!
Presented by:
Dale Cooke
PhillyCooke Consulting
12 September 2014
2. !
Disclosure: PhillyCooke Consulting is not a law
firm, and nothing provided in this presentation
should be construed as offering legal advice.
Specific details of each company’s promotional
efforts might require adjustments of the
information provided in this presentation.
3. Topics
1.Anatomy of a Paid Search Campaign
2.2009 Enforcement
3.New Ad Formats
4.FDA Guidance
5.Compliant Ad Formats
3
6. Home of the Internet
6
Paid Search Highlighted in Red Boxes;
Organic Results in Blue Box
7. Elements of a Text Ad
7
Sitelink &
Description
Display URL
Headline
Description
Destination URL:
http://www.lantus.com/starting/getting-on-track/lantus?
WT.mc_id=LNWB4274&WT.srch=1&iq_id=58226460-
VQ6-33575107656-VQ15-1t1-VQ16-c
8. Character-Count Limitations
Headline: 25 characters (18 on mobile)*
Display URL: 35 characters (20 on mobile)*
Description: 70 characters (18 on mobile)*
Sitelinks: 25 characters each
‣ Maximum of 10 links per campaign
‣ 2-6 will display with each ad
Sitelink Descriptions: 70 characters (0 on mobile)*
Destination URL: 2,048 characters
!
* Character counts include spaces
8
14. Disease Awareness Ads
‣ Link to disease awareness campaigns
‣ Cannot mention products
‣ Cannot imply a specific product
‣ Cannot be combined with product reminder
ads to form a single message
When done correctly, FDA has no authority
over these
14
15. Reminder Advertising
21 CFR 202.1(e)(2)(i), 201.100, 200.200
“Reminder advertisements are those which call
attention to the name of the drug product but do not
include indications or dosage recommendations for
the use of the drug product.”
!
No compliant reminder ad was cited in the 14 letters
15
16. Reminder Ads
1. Brand name (if applicable)*
2. Generic name*
3. Quantitative ingredient statements (e.g., 20 mg)
4. Dosage form (e.g., tablets, capsules)
5. Package contents (e.g., 30 tablets)
6. Price
7. Other information so long as it makes “no
representation or suggestion” about the product use
A. “FDA-approved”
B. Call to action devoid of product description
C. Universal features (e.g., PI, “Dosage”)
!
* Required 16
18. Redirecting Ads
‣ Link to product sites
‣ Cannot mention products
‣ Cannot imply a specific product
‣ Cannot be combined with product reminder
ads to form a single message
When done correctly, FDA has no authority
over these
18
20. Black Box Drugs
‣ 14 of the 48 drugs cited had a black box
‣ Reminder ads are not permitted for black
box drugs
‣ None of the cited drugs was using an
otherwise compliant reminder ad format
Bayer’s Yaz
‣ Had a black box warning in 2009
‣ Cited as part of the 2009 letters
‣ Separately agreed to submit all materials
prior to use
20
23. Sitelinks
“[S]itelinks … [are] links to specific pages on
your website beneath the text of your ads (and
in addition to the main landing page), helping
customers get to what they're looking for on
your site with just one click.”
—From Google Sitelink Description
https://support.google.com/adwords/answer/2375416?hl=en
23
24. Sitelink Limitations
‣ Sitelinks won’t always appear
‣ Sitelink descriptions will not appear on
mobile
‣ Exact order of sitelinks might vary
24
25. Mobile Ads
25
Unique Constraints
Headline: 18 characters
Display URL: 20 characters
Description: 18 characters
Sitelinks: 25 characters
Sitelink
Descriptions: Will NOT appear
28. FDA Recommendations
May provide benefit & risk in space-limited contexts so long as
message includes
1. Brand name
2. Generic name
3. Non-misleading indication statement
4. Abbreviated risk info (with ALL life-threatening risks)
5. Link to
a. Full risk information
b. Dosage form
c. Quantitative ingredient information
d. Full label
To save space, sponsors may
1. Use scientific abbreviation
2. Use linguistic symbols (e.g., & instead of “and”)
3. Use punctuation instead of words (e.g., — to separate
ideas) 28
29. Sample Message*
NoFocus (rememberine HCl)
(Brand & Generic Name—25 characters)
for mild to moderate memory loss
(Indication—34 characters)
May cause seizures in patients with a seizure disorder
(Risk Statement—54 characters)
www.nofocus.com/risk
(Display URL—20 characters)
!
* This is a modified version of the Tweet example from the FDA
guidance. This message is too long for an SEM ad.
29
30. FDA on Sitelinks
FDA suggests the following SEM ad:
30
“FDA would not intend to object to this
sponsored link format for Headhurtz”
—page 15
Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations—
Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
!
31. Brand & Generic Name
Non-misleading Indication Statement
Balancing Risk Information Dedicated Link to Risk Information
32. What Users Would See
!
!
!
This SEM ad does not meet
fair balance requirement
It is violative!
32
35. Compliant Ad Formats
Reminder Ads include brand and generic
names with no representation of usage.
Redirecting Ads include no mention or
implication of a specific product, but redirect to
a product website.
Black Box Ads use Google’s dedicated line of
copy indicating severe warnings apply.
Disease Awareness Ads neither mention nor
imply any specific product and take users to a
disease awareness website. These are not
subject to FDA regulation when properly
35
36. If using sitelinks
1. Do NOT include required information in the
sitelinks (e.g., generic name or balancing
risk information)
2. Make sure sitelinks are compatible with
overall ad format
a. If the main ad is a reminder ad, then the sitelink cannot
imply the product usage.
b. If the main ad is a redirecting ad that omits the product
name, then the sitelink cannot imply or name a specific
product.
36
38. Speaker Bio: Dale Cooke
!
Dale Cooke is the owner of PhillyCooke Consulting, which provides advice and training to
companies about developing compliant promotional materials for FDA-regulated products.
Dale has worked with more than 30 pharmaceutical and medical device clients around the
world. His insights have been featured in the Wall Street Journal’s Health blog, The Pink
Sheet, MedAdNews, PharmExec, and others. Dale is an active member of the Regulatory
Affairs Professionals Society (RAPS), Drug Information Association (DIA), Food and Drug Law
Institute (FDLI), and the Alliance for a Stronger FDA. He also serves on the faculty of the
University of California San Francisco’s American Course in Drug Development and
Regulatory Sciences program.
!
Dale is the author of Effective Review and Approval of Digital Promotional Tactics, which is
part of FDLI’s primer series. He is regularly invited to speak at industry conferences on topics
including FDA enforcement trends, best practices for review processes, global review
practices, and life sciences use of social media. Previously, Dale served as the head of
Regulatory for Digitas Health LifeBrands, which is part of the Publicis Healthcare
Communications Group.
!
Dale earned his B.A. in Philosophy from Southern Methodist University, an M.A. in Analytical
Philosophy from the University of Arizona, and studied Epidemiology and Biostatistics at
Drexel University’s School of Public Health and Healthcare Compliance at Seton Hall
University’s School of Law. 38