GlaxoSmithKline paid $20 million to settle a US foreign bribery case for disguising bribes to Chinese officials as legitimate expenses from 2010 to 2013. The bribes were meant to boost sales through increased prescriptions and hospital purchases. They came in the form of gifts, travel, shopping, and cash. This is not the first bribery scandal for GSK, as in 2014 China fined them $490 million for admitting to paying bribes to doctors and hospitals to promote their products illegally. Pharmaceutical companies paid large fines in 2016 for foreign corrupt practices.
Pharmacovigilance in USA and Europe_Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in USA and Europe for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting Sys...Perficient, Inc.
Ever since the European Union (EU) introduced new legislation that requires life sciences companies to proactively detect, prioritize, and evaluate safety signals, there has been an increased interest, not only from sponsors and CROs in the EU, but globally, in pharmacovigilance systems that can assist with the signal management process.
Perficient's Chris Wocosky, an expert in signal detection and management, shows how your organization can use Empirica Signal, Oracle's state-of-the-art signal detection system to data mine the existing FDA Adverse Event Reporting System (FAERS) to determine safety signals. This presentation and demonstration willhelp you bettter understand how this solution can be used in daily pharmacovigilance activities.
January 29, 2014 Presentation to Compliance2Go webinar, focusing on:
• Legal Framework for 510(k)’s
• Strategy Considerations – Claims & Functions
• Device Modifications
• Regulatory Mechanisms to Implement Changes
• The Review
• What To Do if FDA Says You’re NSE
• Key Lessons Learned
• Reform and Other Recent Trends at FDA
Changes in the pipeline for the traceability of medical devices and equipment. Unique Device Identification, Global Medical Device Nomenclature, barcodes and more!
Pharmacovigilance in USA and Europe_Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in USA and Europe for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting Sys...Perficient, Inc.
Ever since the European Union (EU) introduced new legislation that requires life sciences companies to proactively detect, prioritize, and evaluate safety signals, there has been an increased interest, not only from sponsors and CROs in the EU, but globally, in pharmacovigilance systems that can assist with the signal management process.
Perficient's Chris Wocosky, an expert in signal detection and management, shows how your organization can use Empirica Signal, Oracle's state-of-the-art signal detection system to data mine the existing FDA Adverse Event Reporting System (FAERS) to determine safety signals. This presentation and demonstration willhelp you bettter understand how this solution can be used in daily pharmacovigilance activities.
January 29, 2014 Presentation to Compliance2Go webinar, focusing on:
• Legal Framework for 510(k)’s
• Strategy Considerations – Claims & Functions
• Device Modifications
• Regulatory Mechanisms to Implement Changes
• The Review
• What To Do if FDA Says You’re NSE
• Key Lessons Learned
• Reform and Other Recent Trends at FDA
Changes in the pipeline for the traceability of medical devices and equipment. Unique Device Identification, Global Medical Device Nomenclature, barcodes and more!
After adoption and success of E2B R2 for almost a decade finally change was brought to tear down and bring some more updates to the existing ICSR Elements Design.
IN THIS SUMMARY
The United States Food and Drug Administration (FDA) has significant reach in the American economy, ranging from medicines and medical devices to items on the grocery store shelves. Since its inception in 1906, the agency has faced a variety of technical and political challenges. Looking ahead, the FDA faces many new demands that could enlarge the agency’s already expansive mandate. New responsibilities may include the cost of medicine, consumers’ pursuit of perfection through drugs, consumer lifestyles, tobacco, and counterterrorism. As the nature of public health changes over time, it is inevitable that the FDA’s scope and responsibilities will change as well. In Inside the FDA, Fran Hawthorne explains the history of the FDA, how its processes work, and what the future may hold for this government agency.
SUBSCRIBE TODAY
http://www.bizsum.com/summaries/inside-fda
Argus Patient Screen Tab Training - Katalyst HLSKatalyst HLS
Introduction to Argus Patient Screen Tab in Pharmacovigilance or Drug Safety of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
GEOGRAPHICAL INDICATIONS OF INDIAN GOODS & INDIAN PATENT SCENARIOKapilKumar198
This presentation contains information about the Geographical Indications of Indian Goods and the Procedure for Filing application for registration of Geographical Indication and basic information about INDIAN PATENT SCENARIO.
This generally deals with ANDA litigation in United states with Paragraph iv litigation generally. It also emphasizes on Cost involved in ANDA litigation with different methods for reducing the cost.and how many million or billion at stake when Generic and Branded drugs. It also covers the litigation part of District New Jersey that how and in what manner litigation with respect to Hatch-waxman act an is done along with the timelines and CAFC timelines.
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
Key Compliance Issues In Clinical Research: What Sites, CROs, and Start-Ups N...Polsinelli PC
Clinical research presents a host of potential compliance and legal risks. This webinar will provide an overview of key legal issues in clinical research applicable to all involved parties, including sponsors, sites and CROs. We will also review recent enforcement activities related to research studies, and provide strategies for addressing issues that arise, both preemptively (through compliance plans) and in response to identified concerns.
Our agenda:
• Understand key rules and regulations and how they apply in the context of clinical research
• Review key areas of compliance risk, ranging from Medicare reimbursement and billing concerns to informed consent and use of equipment and materials in clinical research
• Outline key components of compliance plans and specifics relevant to clinical research
This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
This presentation explains concepts of Patents and Market Exclusivity. This presentation is compiled from publicly available material on the world wide web.
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
After adoption and success of E2B R2 for almost a decade finally change was brought to tear down and bring some more updates to the existing ICSR Elements Design.
IN THIS SUMMARY
The United States Food and Drug Administration (FDA) has significant reach in the American economy, ranging from medicines and medical devices to items on the grocery store shelves. Since its inception in 1906, the agency has faced a variety of technical and political challenges. Looking ahead, the FDA faces many new demands that could enlarge the agency’s already expansive mandate. New responsibilities may include the cost of medicine, consumers’ pursuit of perfection through drugs, consumer lifestyles, tobacco, and counterterrorism. As the nature of public health changes over time, it is inevitable that the FDA’s scope and responsibilities will change as well. In Inside the FDA, Fran Hawthorne explains the history of the FDA, how its processes work, and what the future may hold for this government agency.
SUBSCRIBE TODAY
http://www.bizsum.com/summaries/inside-fda
Argus Patient Screen Tab Training - Katalyst HLSKatalyst HLS
Introduction to Argus Patient Screen Tab in Pharmacovigilance or Drug Safety of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
GEOGRAPHICAL INDICATIONS OF INDIAN GOODS & INDIAN PATENT SCENARIOKapilKumar198
This presentation contains information about the Geographical Indications of Indian Goods and the Procedure for Filing application for registration of Geographical Indication and basic information about INDIAN PATENT SCENARIO.
This generally deals with ANDA litigation in United states with Paragraph iv litigation generally. It also emphasizes on Cost involved in ANDA litigation with different methods for reducing the cost.and how many million or billion at stake when Generic and Branded drugs. It also covers the litigation part of District New Jersey that how and in what manner litigation with respect to Hatch-waxman act an is done along with the timelines and CAFC timelines.
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
Key Compliance Issues In Clinical Research: What Sites, CROs, and Start-Ups N...Polsinelli PC
Clinical research presents a host of potential compliance and legal risks. This webinar will provide an overview of key legal issues in clinical research applicable to all involved parties, including sponsors, sites and CROs. We will also review recent enforcement activities related to research studies, and provide strategies for addressing issues that arise, both preemptively (through compliance plans) and in response to identified concerns.
Our agenda:
• Understand key rules and regulations and how they apply in the context of clinical research
• Review key areas of compliance risk, ranging from Medicare reimbursement and billing concerns to informed consent and use of equipment and materials in clinical research
• Outline key components of compliance plans and specifics relevant to clinical research
This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
This presentation explains concepts of Patents and Market Exclusivity. This presentation is compiled from publicly available material on the world wide web.
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
Off-Label Drug Promotion and the Use of DisclaimersfalseMcKenney,.docxhopeaustin33688
Off-Label Drug Promotion and the Use of Disclaimers*
falseMcKenney, Dina. Texas Law Review92.1 (2013): 231-252.
Abstract (summary)
In July 2012, the Department of Justice (DOJ) announced a record health care fraud settlement: GlaxoSmithKline would pay $3 billion, in part to resolve allegations that the company engaged in off-label promotion of pharmaceutical drugs such as Paxil and Wellbutrin. According to both the DOJ and the Food and Drug Administration (FDA), promoting a drug for an off-label use is a violation of the Federal Food, Drug, and Cosmetic Act's misbranding provisions. In one of many allegations against GlaxoSmithKline, the government contended that the company unlawfully promoted Paxil for pediatric use, despite the fact that it was only approved for treating depression in individuals eighteen years of age and older. Part I examines the current regulatory scheme in place for off-label promotion and the possible benefits and consequences of allowing the promotion of off-label uses. Part II discusses how current case law regarding commercial speech threatens the government's off-label promotion prosecution scheme.
In July 2012, the Department of Justice (DOJ) announced a record health care fraud settlement: GlaxoSmithKline would pay $3 billion, in part to resolve allegations that the company engaged in off-label promotion of pharmaceutical drugs such as Paxil and Wellbutrin. According to both the DOJ and the Food and Drug Administration (FDA), promoting a drug for an off-label use is a violation of the Federal Food, Drug, and Cosmetic Act's misbranding provisions. In one of many allegations against GlaxoSmithKline, the government contended that the company unlawfully promoted Paxil for pediatric use, despite the fact that it was only approved for treating depression in individuals eighteen years of age and older. Part I examines the current regulatory scheme in place for off-label promotion and the possible benefits and consequences of allowing the promotion of off-label uses. Part II discusses how current case law regarding commercial speech threatens the government's off-label promotion prosecution scheme.
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Talc is a main ingredient in Johnson & Johnson baby powder. The U.S. Food and Drug Administration classifies talc as a cosmetic. Cosmetics are regulated less stringently by the FDA.
In 2022, the minimal residual disease testing market was worth around USD 1,156.8 million, and it is projected to advance at a 15.1% CAGR from 2022 to 2030, hitting USD 3,570.1 million in 2030, according to P&S Intelligence.
The life sciences industry is a key contributor to the Canadian and global economies. In the pursuit of competitive advantage, participants in the pharmaceutical, biotech, medical device and diagnostic, and health-careservices sectors have seen significant growth attributed to major leaps in technology and an unprecedented demand for health-related goods and services. This growth has paralleled the expansion and imposition of more stringent regulatory requirements, improvement of market access, aggressive patent acquisition and enforcement, strategic M&A activity, and increased product liability claims and other litigation.
This report highlights insights and developments relating to a wide range of legal, business and consumer issues currently impacting the life sciences industry in Canada and abroad. These highlights were prepared by Blakes based on non-confidential information gathered in our practices, as well as through a review of publicly available information. Through
a series of articles, we examine the implications of some of the recent legal developments impacting the sector, including the Supreme Court of Canada’s decision to uphold Ontario’s ban on private-label generic drugs, the enforcement of prohibitions on pharmacy-related loyalty points in B.C., the Competition Bureau’s ongoing consideration of competition among pharmaceutical companies, and recent trends in Canadian litigation. We also discuss issues relating to the navigation of transfer-pricing rules, protecting intellectual property in the development of combination products, and obtaining financing for new product development and business expansion efforts. Supplementing our discussion of these matters are snapshots of consumer-facing and market trends, including integrated patient care and direct-to-consumer sales.
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
Health Education on prevention of hypertensionRadhika kulvi
Hypertension is a chronic condition of concern due to its role in the causation of coronary heart diseases. Hypertension is a worldwide epidemic and important risk factor for coronary artery disease, stroke and renal diseases. Blood pressure is the force exerted by the blood against the walls of the blood vessels and is sufficient to maintain tissue perfusion during activity and rest. Hypertension is sustained elevation of BP. In adults, HTN exists when systolic blood pressure is equal to or greater than 140mmHg or diastolic BP is equal to or greater than 90mmHg. The
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
R3 Stem Cells and Kidney Repair: A New Horizon in Nephrology" explores groundbreaking advancements in the use of R3 stem cells for kidney disease treatment. This insightful piece delves into the potential of these cells to regenerate damaged kidney tissue, offering new hope for patients and reshaping the future of nephrology.
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
Telehealth Psychology Building Trust with Clients.pptx
GlaxoSmithKline Bribery & Corruption Case
1. 1
GlaxoSmithKline Bribery & Corruption Case
Thomson Reuters Regulator Intelligence
REUTERS/Jason Lee
Know Your 3rd Party Risk
Christel Boutros
2. 2
AGENDA
• GlaxoSmithKline PLC Introduction
• GlaxoSmithKline PLC Bribery and Corruption Case
• Pharma Industry Bribery and Corruption Cases in 2016
3. 3
GLAXOSMITHKLINE PLC – INTRODUCTION
GlaxoSmithKline PLC is a research-based pharmaceutical company. The
Company develops, manufactures, and markets vaccines, prescription, and over-
the-counter medicines, as well as health-related consumer products.
GlaxoSmithKline provides products for infections, depression, skin conditions,
asthma, heart and circulatory disease, and cancer.
03-10-2016
4. 4
GlaxoSmithKline had to pay $20 million to settle U.S. foreign bribery case and settle civil charges
that it masked bribes to foreign officials in China by disguising them as legitimate travel, entertainment and
marketing expenses. The company's China-based subsidiary and a China-based joint venture violated
internal controls and record-keeping provisions of the Foreign Corrupt Practices Act.
From 2010 through June 2013, the company's employees and agents bribed officials in order to boost
its sales through increases in prescriptions and purchases by hospitals.
The payments came in the form of gifts, travel, shopping excursions and cash, among other things
such as medical association sponsorships, employee expenses, conferences, speaker fees and marketing
costs
The pharmaceutical company agreed to settle the case with the Securities and Exchange Commission
without admitting or denying any wrongdoing.
In a statement, the company said it had cooperated with the SEC and it had received credit for taking
steps to improve its operations, such as changing how sales representatives are paid and stopping the
practice of paying healthcare professionals to speak to doctors about the company's products.
The SEC's $20 million civil settlement with GlaxoSmithKline resolves the latest case to emerge from
an industry-wide sweep that started in 2010.
GLAXOSMITHKLINE PLC – BRIBERY AND CORRUPTION CASE
5. 5
This is not the first bribery scandal for GSK. In 2014, China fined GSK $490M after they
pleaded guilty to paying bribes to doctors and hospitals to have their products promoted. The
company was accused of having made an estimated $150M in illegal profits and a number
of GSK executives were jailed for this scandal.
PHARMA INDUSTRY BRIBERY AND CORRUPTION CASES IN 2016
2016 FCPA fines in the
pharma industry
Total amounting in
combined settlements.