The World Health Organization’s Pharmacovigilance Program
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Formerly based in Connecticut where he worked with Bristol-Myers Squibb, Robert Hindes, MD, has served Trek Therapeutics as chief medical officer since 2014. In this role, Robert Hindes, MD, directly supervises Trek’s pharmacovigilance (PV) program.
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This document discusses healthcare-associated infections (HAIs) and presents information from AdvaMed. It notes that HAIs occur worldwide and affect hundreds of millions annually, increasing morbidity, mortality, and costs. Up to 90% of HAI deaths in the US are caused by multi-drug resistant organisms. Surveillance shows HAI incidence is 3 times higher in developing economies compared to EU/US. HAIs lead to prolonged hospital stays and increased costs. Prevention through evidence-based interventions could reduce HAIs by 65-70% and save resources. Strong infection control including surveillance is needed to combat HAIs and antimicrobial resistance.
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3) Addressing barriers like stigma to make hepatitis services accessible for all populations.
4) Building political commitment and innovative funding approaches for sustainable financing.
5) Prioritizing hepatitis research and rapidly translating findings into practice.
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This presentation includes introduction to WHO International Drug Monitoring Program & its functions, Role of WHO in PV, Vigibase, regulatory terminology of ADR and evaluation of medication safety.
Pharmacovigilance
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
Cdc
The Center for Disease Control and Prevention (CDC) is a federal agency within the United States Department of Health and Human Services headquartered in Atlanta, Georgia. The CDC conducts and supports health promotion, prevention and preparedness activities in the US with the goal of improving public health. It is organized into centers, institutes, and offices that allow it to respond effectively to various public health concerns both domestically and internationally through partnerships with organizations such as the World Health Organization.
Center for disease control
The Centers for Disease Control and Prevention (CDC) is a federal agency that conducts and supports health promotion, prevention and preparedness activities in the US with the goal of improving overall public health. It was established in 1946 and is headquartered in Atlanta, Georgia. The CDC monitors and prevents disease outbreaks, implements disease prevention strategies, and maintains national health statistics. It focuses on infectious diseases, foodborne pathogens, environmental health, and more. The CDC is organized into centers, institutes, and offices to effectively address public health concerns. It works with partners at local, state, and national levels.
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The Pharmacovigilance Programme of India is an Indian government organization which identifies and responds to drug safety problems. Its activities include receiving reports of adverse drug events and taking necessary action to remedy problems.
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The document discusses pharmacovigilance and the establishment of a nationwide pharmacovigilance program in India. It describes how India launched the Pharmacovigilance Program of India (PvPI) in 2010 with the objectives of monitoring adverse drug reactions, analyzing safety risks and benefits of medicines, and supporting regulatory decision making. The PvPI operates through a national coordination center and network of reporting centers across India to collect adverse drug reaction reports and contribute to global pharmacovigilance efforts through the WHO.
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Role of Pharmacovigilance in Drug Discovery and Post Marketing Surveillance
Pharmacovigilance is a cornerstone of both the pharmaceutical industry and the healthcare system. It is aimed to ensure guaranteed patient safety and is considered an arm of patient care. Pharmacovigilance is essential at many stages of the drug discovery and development process. Drug safety assures that a patients safety and well being are protected throughout the whole drug development lifecycle, including when the drug is easily available on the market. Pharmacovigilance comprises pre and post marketing surveillance. Pre clinical screening, which collects information on ADRs from phases I to III of clinical trials, and post marketing surveillance, which gathers data from the post approval stage and during the course of a drugs shelf life. During clinical trials pharmacovigilance mandates the timely submission of reports on adverse events during clinical trials to regulatory authorities, notification of such events to all investigators and ethics committees, and a safety review by independent Drug Safety Monitoring Boards DSMB . Predicting or evaluating potential ADRs at this early stage of the drug development pipeline is the focus of PV. Finding previously unrecognized adverse effects as well as good effects is the major goal of PMS research by utilizing various pharmacovigilance methodologies. K. Sravanathi Bai | V. Venu "Role of Pharmacovigilance in Drug Discovery & Post-Marketing Surveillance" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-3 , June 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd57400.pdf Paper URL: https://www.ijtsrd.com.com/pharmacy/other/57400/role-of-pharmacovigilance-in-drug-discovery-and-postmarketing-surveillance/k-sravanathi-bai
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The document discusses global health policies and initiatives. It outlines health policy aims like maintaining and improving population health status. It discusses key global health strategies like Health for All by 2000, the Millennium Development Goals, and Sustainable Development Goals. It provides details on initiatives like the Global Fund to Fight AIDS, Tuberculosis and Malaria, GAIN (Global Alliance for Improved Nutrition), and progress made in combating diseases like HIV/AIDS, tuberculosis, and malaria.Global health policy
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The document discusses several international health agencies including WHO and UNICEF. It provides details on their establishment, goals, activities, and collaboration with Indian agencies. WHO works to promote health and prevent disease worldwide. It aims to achieve 'Health for All'. UNICEF was established in 1946 to help children in need and works to support child survival, development, protection, education, and HIV/AIDS prevention. Its GOBI campaign promotes growth monitoring, oral rehydration, breastfeeding, and immunization.
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The document is the 2008-2009 Forward Programme for the World Alliance for Patient Safety. It outlines the Alliance's work over the next two years to improve patient safety globally. The key areas of focus are: 1) Assessing and understanding problems of unsafe care through reporting/learning systems and the International Classification for Patient Safety; 2) Developing safety standards and solutions through initiatives on hand hygiene, surgery checklists, and technology; 3) Improving knowledge access and use through global safety challenges, research, and evaluations; 4) Promoting innovation and commitment through programs on patients, prizes, and education; 5) Strengthening safety capacity through knowledge management. The Forward Programme provides a framework to support WHO members and partners in building
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The document summarizes the World Health Organization (WHO) and Canada's support and collaboration with WHO. It discusses that WHO was established in 1948 and is responsible for international public health. Canada works closely with WHO to reduce global diseases like polio, HIV/AIDS, tuberculosis, and malaria. Canada also contributes funding to WHO and supports initiatives like the development of an Ebola vaccine. The document outlines several areas of collaboration between Canada and WHO, including on health emergencies, maternal and child health, and improving health systems.
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The World Health Organization (WHO) was established in 1948 as a specialized UN agency with a mission to serve as the global authority on international health. WHO played a key role in the development and achievement of the Millennium Development Goals (MDGs) and Sustainable Development Goals (SDGs) related to health through providing technical expertise, setting global norms and standards, monitoring progress, advocating for resources, and building country capacity. WHO's contributions significantly helped reduce poverty, hunger, child and maternal mortality, and the burden of diseases globally.
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Trek Therapeutics co-founder Robert Hindes, MD was previously a member of the faculty at Yale University in Connecticut. A consultant with a strong background in the pharmaceutical industry, Robert Hindes, MD consults with drug manufacturers on clinical trials for new drugs.
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Robert Hindes, an expert in internal medicine and infectious diseases, discusses non-opioid treatment options for chronic pain. These include over-the-counter medications like ibuprofen and acetaminophen, which are generally not effective enough for long-term chronic pain. Non-drug therapies include electrical stimulation, nerve blocks, and injections of drugs that block or destroy pain fibers, such as capsaicin and resiniferatoxin. Spinal cord stimulation and cryoneurolysis (freezing nerves) can also help reduce chronic pain but tend to be more expensive. Stem cell research may lead to additional non-opioid options in the future.
RTX – Revolutionary Chronic Pain Treatment May Reduce Opioid Reliance
Robert Hindes, MD, formerly of Trek Therapeutics and Sorrento Therapeutics, helped develop resiniferatoxin (RTX), an injectable treatment for chronic pain from conditions like arthritis and cancer. [RTX] targets and permanently disables the nerve endings that transmit pain signals locally, potentially revolutionizing pain treatment. It specifically targets pain nerves without affecting other sensations, and eliminates chronic pain without the side effects of opioids by disabling oversensitive pain neurons and removing dependence on opioids.
Preventing the Transmission of Hepatitis C
The vice president of clinical research at Sorrento Therapeutics, Robert Hindes, MD, develops innovative therapeutic approaches in the treatment of autoimmune disease. Robert Hindes, MD, also serves as the chief medical officer of Trek Therapeutics in Cambridge, Massachusetts, where he supports the company’s mission to create affordable, accessible treatments for people with diseases such as hepatitis C (HCV).
Pharmasset
PSI-7977 is a nucleotide analog polymerase inhibitor being studied for the treatment of HCV. A Phase 2b trial found that once daily PSI-7977 plus pegylated interferon and ribavirin achieved a 98% rapid virologic response rate in treatment-naive HCV genotype 1 patients. A separate trial found that all 24 treatment-naive HCV genotype 2/3 patients achieved undetectable viral loads by week 4 of once daily PSI-7977 plus pegylated interferon and ribavirin therapy, and all patients maintained an undetectable viral load through week 12. Preliminary viral dynamic modeling of PSI-7977 data suggests a relationship between drug exposure levels and antiviral response
Trek Therapeutics' Work as a Public-Benefit Corporation
The former group director of virology at Bristol-Myers Squibb in Wallingford, Connecticut, Robert Hindes, MD, co-founded Trek Therapeutics in September 2014. As the organization’s chief medical officer, Robert Hindes, MD, is responsible for the development of clinical strategy.
What Are the Different Phases of Clinical Trials?
Clinical trials are broken down into five phases. Phase 0 involves limited exposure to human subjects for exploratory purposes. Phase I tests new treatments on a small number of people to evaluate safety and side effects. Phase II expands trials to more people to generate data on effectiveness at different doses and durations. Phase III further expands trials to large and diverse populations to demonstrate safety and efficacy compared to approved treatments. Phase IV occurs after approval to obtain additional data on effects in the general population.
Robert Hindes MD - Trek comprehensive confidential investor ak4 deck 2016
TREK Therapeutics is developing affordable treatments for hepatitis C using two licensed assets - Faldaprevir (FDV, a protease inhibitor) and TD-6450 (an NS5A inhibitor). TD-6450 has shown potent viral load reductions in genotype 1 patients in clinical trials. The company aims to develop low-cost regimens using these assets for global markets and is currently conducting a phase 2a trial of FDV+TD-6450 for genotype 4 patients in the US. TREK is uniquely positioned with these well-characterized assets and an experienced management team to rapidly develop and commercialize regimens for major global markets.
A New Therapy May Help Patients with HCV
Robert Hindes, MD is the chief medical officer of Trek Therapeutics, a company seeking new treatments for hepatitis C virus (HCV). Doctors at Monash University are urging the Australian government to subsidize new direct-acting antiviral drugs that can cure HCV to prevent thousands of avoidable deaths from liver disease. The new drugs work by disrupting HCV replication and infection. Researchers cited the drugs' high cure rates but noted that without subsidies, their high cost puts them out of reach for most patients and could lead to over 22,000 HCV-related deaths in Australia by 2030.
The Co-Infection of HCV and HIV
Dr. Robert Hindes published numerous articles on infectious diseases like hepatitis B and C after completing a research fellowship at Harvard Medical School. The document discusses the co-infection of hepatitis C virus (HCV) and human immunodeficiency virus (HIV), noting that HCV is transmitted through contact with an infected person's blood, often from sharing needles, and this increases the risk of co-infection with HIV. It states that co-infected patients experience accelerated liver disease according to the National Institutes of Health.
American Liver Foundation Rallies Support for Liver Life Walks
Robert Hindes, MD founded Trek Therapeutics in 2014 to develop more affordable treatments for hepatitis C and other infectious diseases. The CDC estimates that over 4 million Americans have chronic hepatitis B or C, which can lead to liver disease, cirrhosis, and cancer. While current antiviral treatments are effective for many patients, barriers to treatment still exist for some. The American Liver Foundation holds annual Liver Life Walks across the country in May and June to raise funds and awareness for hepatitis and other liver diseases.
Research Examines Combination Treatment for Hepatitis C
A study examined the combination of sofosbuvir, ribavirin, and pegylated interferon alfa-2a to treat genotype 1 hepatitis C infection. Researchers divided patients into three cohorts receiving different treatment regimens and found patients tolerated sofosbuvir well over 12 weeks. The study concluded further trials should examine sofosbuvir therapy for people with hepatitis C and cirrhosis.
Sofosbuvir Inhibitor Helps Fight Hepatitis C
Robert Hindes, MD helped develop sofosbuvir, a potent nucleotide analogue, while vice president of clinical development at Pharmasset. Sofosbuvir inhibits HCV polymerase and is currently the most effective drug being tested to treat hepatitis C. After Gilead Sciences acquired Pharmasset, they conducted Phase 3 clinical trials of sofosbuvir alone and in combination with other agents like ribavirin. These combinations resulted in high sustained response rates up to 12 weeks post treatment.
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本公司拥有海外各大学样板无数，能完美还原。
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留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
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本公司拥有海外各大学样板无数，能完美还原。
1:1完美还原海外各大学毕业材料上的工艺：水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠。文字图案浮雕、激光镭射、紫外荧光、温感、复印防伪等防伪工艺。材料咨询办理、认证咨询办理请加学历顾问Q/微741003700
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一.毕业证【q微741003700】成绩单、使馆认证、教育部认证、雅思托福成绩单、学生卡等！
二.真实使馆公证(即留学回国人员证明,不成功不收费)
三.真实教育部学历学位认证（教育部存档！教育部留服网站永久可查）
四.办理各国各大学文凭(一对一专业服务,可全程监控跟踪进度)
如果您处于以下几种情况：
◇在校期间，因各种原因未能顺利毕业……拿不到官方毕业证【q/微741003700】
◇面对父母的压力，希望尽快拿到；
◇不清楚认证流程以及材料该如何准备；
◇回国时间很长，忘记办理；
◇回国马上就要找工作，办给用人单位看；
◇企事业单位必须要求办理的
◇需要报考公务员、购买免税车、落转户口
◇申请留学生创业基金
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
World Food Safety Day 2024- Communication-toolkit.
Food safety, prepare for the unexpected - So what can be done in order to be ready to address food safety, food Consumers, food producers and manufacturers, food transporters, food businesses, food retailers can ...
PAS PSDF Mop Up Workshop Presentation 2024 .pptx
This is the slide deck of what PAS learnt supporting councils awarded Planning Skills Delivery Funds
CBO’s Outlook for U.S. Fertility Rates: 2024 to 2054
Presentation by Molly Dahl, CBO's Long-Term Analysis Unit Chief, at a conference organized by the National Bureau of Economic Research.
A Guide to AI for Smarter Nonprofits - Dr. Cori Faklaris, UNC Charlotte
Working with data is a challenge for many organizations. Nonprofits in particular may need to collect and analyze sensitive, incomplete, and/or biased historical data about people. In this talk, Dr. Cori Faklaris of UNC Charlotte provides an overview of current AI capabilities and weaknesses to consider when integrating current AI technologies into the data workflow. The talk is organized around three takeaways: (1) For better or sometimes worse, AI provides you with “infinite interns.” (2) Give people permission & guardrails to learn what works with these “interns” and what doesn’t. (3) Create a roadmap for adding in more AI to assist nonprofit work, along with strategies for bias mitigation.
Texas Water Development Board Updates June 2024
Presented at June 6-7 Texas Alliance of Groundwater Districts Business Meeting
加急办理华威大学毕业证硕士文凭证书原版一模一样
原版一模一样【微信：741003700 】【华威大学毕业证硕士文凭证书】【微信：741003700 】学位证，留信认证（真实可查，永久存档）offer、雅思、外壳等材料/诚信可靠,可直接看成品样本，帮您解决无法毕业带来的各种难题！外壳，原版制作，诚信可靠，可直接看成品样本。行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备。十五年致力于帮助留学生解决难题，包您满意。
本公司拥有海外各大学样板无数，能完美还原海外各大学 Bachelor Diploma degree, Master Degree Diploma
1:1完美还原海外各大学毕业材料上的工艺：水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠。文字图案浮雕、激光镭射、紫外荧光、温感、复印防伪等防伪工艺。材料咨询办理、认证咨询办理请加学历顾问Q/微741003700
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
2024: The FAR - Federal Acquisition Regulations, Part 41
Jennifer Schaus and Associates hosts a complimentary webinar series on The FAR in 2024. Join the webinars on Wednesdays and Fridays at noon, eastern.
Recordings are on YouTube and the company website.
https://www.youtube.com/@jenniferschaus/videos
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The World Health Organization’s Pharmacovigilance Program
- 1. The World Health Organization’s Pharmacovigilance Program Robert Hindes MD
- 2. Introduction • Formerly based in Connecticut where he worked with Bristol-Myers Squibb, Robert Hindes, MD, has served Trek Therapeutics as chief medical officer since 2014. In this role, Robert Hindes, MD, directly supervises Trek’s pharmacovigilance (PV) program. The World Health Organization (WHO) defines PV as any activities or scientific works that relate to the assessment, understanding, detection, and prevention of drug-related adverse effects and problems. The concept came to prominence in the wake of the thalidomide disaster of the early 1960s, during which many pregnant women who took the drug thalidomide gave birth to children with birth defects.
- 3. Pharmacovigilance Program • WHO’s response was the creation of the Programme for International Drug Monitoring, which maintained 134 member countries at the end of 2010. The initiative’s aim is to improve patient safety and care through the rigorous examination of medicines. Further, it provides fair and reliable information relating to the assessment of medicine risk-benefit profiles. Membership is open to WHO member states that have implemented an individual case safety reports (ICSRs) collection program. Applicants must provide WHO with a minimum sample of 20 ICSRs alongside the formal application.