Assessing the European Commission's Proposal to Revise the Clinical Trial Dir...Cognizant
With a revision of the clinical trials directive impending, we offer a six-stage process for life sciences organizations to best prepare to capitalize on the changes in the CTD.
EMA Guidelines for Clinical Trial Management - Pepgra HealthcarePEPGRA Healthcare
The European Medicines Agency (EMA) relies on the results of clinical trials carried out by pharmaceutical companies to reach its opinions on the authorisation of medicines. EMA guidelines for clinical trial regulations adopted in 2014 aim to make it easier for the clinical trials companies while empowering participants through transparency.
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Contact Us:
Website : https://bit.ly/33Fwsye
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Assessing the European Commission's Proposal to Revise the Clinical Trial Dir...Cognizant
With a revision of the clinical trials directive impending, we offer a six-stage process for life sciences organizations to best prepare to capitalize on the changes in the CTD.
EMA Guidelines for Clinical Trial Management - Pepgra HealthcarePEPGRA Healthcare
The European Medicines Agency (EMA) relies on the results of clinical trials carried out by pharmaceutical companies to reach its opinions on the authorisation of medicines. EMA guidelines for clinical trial regulations adopted in 2014 aim to make it easier for the clinical trials companies while empowering participants through transparency.
Continue Reading : http://bit.ly/36LJZa7
Contact Us:
Website : https://bit.ly/33Fwsye
Email us: sales.cro@pepgra.com
Whatsapp: +91 9884350006
Clinical Research Regulation in European Union ShantanuThakre3
- On 16 April 2014, the European Commission adopted the new Clinical Trial Regulation (EU No 536/2014), repealing Directive 2001/20/EC.
- Although the Clinical Trial Regulation was adopted and entered into force in 2014, the timing of its application depends on confirmation of full functionality of the Clinical Trials Information System (CTIS) through an independent audit.
- The Regulation becomes applicable six months after the European Commission publishes notice of this confirmation.
2007-05-18 :The Role, Position and Funding of Laboratory Diagnostics in the G...schlieper
The Role, Position and Funding of Laboratory Diagnostics in the German Health Care System
Warsaw, 18. May 2007
Dr. med. Lothar Krimmel
Bioscientia Institute for Medical Diagnostics
Ingelheim, Germany
R&D, Competition and Diffusion of Innovation in EU: The Case of Direct Acting...Office of Health Economics
An OHE research studies the role of R&D incentives and market competition in facilitating the diffusion of pharmaceutical innovation across European countries. The research studies the case of the DAA treatments for hepatitis C. Methods and results were presented and discussed at EUHEA conference 2018 held in Maastricht, The Netherlands, 11-14 July. The analysis concludes that (i) R&D incentives may have encouraged in-patent competition of DAAs and (ii) competition had a positive impact on uptake and adoption of DAA treatments in the countries studied (top-5 European plus Portugal).
Author(s) and affiliation(s): Mikel Berdud (OHE), Phill O'Neill (OHE), Martina Garau (OHE), Adrian Towse (OHE)
Conference/meeting: EUHEA Conference 2018
Location: Maastricht, The Netherlands
Date: 12/07/2018
Changing medical device regulations in Europe and the U.S.Maetrics
Topics covered at our recent ABHI (UK) event. Slides cover the reprocessing of single-use devices, the benefits of unique device identification, and supporting clinical evidence.
Clinical Research Regulation in European Union ShantanuThakre3
- On 16 April 2014, the European Commission adopted the new Clinical Trial Regulation (EU No 536/2014), repealing Directive 2001/20/EC.
- Although the Clinical Trial Regulation was adopted and entered into force in 2014, the timing of its application depends on confirmation of full functionality of the Clinical Trials Information System (CTIS) through an independent audit.
- The Regulation becomes applicable six months after the European Commission publishes notice of this confirmation.
2007-05-18 :The Role, Position and Funding of Laboratory Diagnostics in the G...schlieper
The Role, Position and Funding of Laboratory Diagnostics in the German Health Care System
Warsaw, 18. May 2007
Dr. med. Lothar Krimmel
Bioscientia Institute for Medical Diagnostics
Ingelheim, Germany
R&D, Competition and Diffusion of Innovation in EU: The Case of Direct Acting...Office of Health Economics
An OHE research studies the role of R&D incentives and market competition in facilitating the diffusion of pharmaceutical innovation across European countries. The research studies the case of the DAA treatments for hepatitis C. Methods and results were presented and discussed at EUHEA conference 2018 held in Maastricht, The Netherlands, 11-14 July. The analysis concludes that (i) R&D incentives may have encouraged in-patent competition of DAAs and (ii) competition had a positive impact on uptake and adoption of DAA treatments in the countries studied (top-5 European plus Portugal).
Author(s) and affiliation(s): Mikel Berdud (OHE), Phill O'Neill (OHE), Martina Garau (OHE), Adrian Towse (OHE)
Conference/meeting: EUHEA Conference 2018
Location: Maastricht, The Netherlands
Date: 12/07/2018
Changing medical device regulations in Europe and the U.S.Maetrics
Topics covered at our recent ABHI (UK) event. Slides cover the reprocessing of single-use devices, the benefits of unique device identification, and supporting clinical evidence.
Lab Quality Confab 2015 - Learnings on French consolidationBertrand Guillot
#MedLab #Improvement #Stragegy What Labs in France are Learning about the Power of Quality Management Systems to Support Standardization and Performance of Multi-site Laboratory Organizations
Quality Management enables organisations to deliver value by fulfilling the needs and expectations of relevant interested parties. Research infrastructures are user and service oriented organisations, hence quality management systems can help them to identify quality objectives and to identify the processes and resources required to meet them. Many of the relatively new European-level research infrastructures in the area of biomedical, social and environmental sciences, but also in other research disciplines, are organised as distributed research infrastructures. This brings about specific requirements and challenges when it comes to implementing quality management systems. This webinar will address some of these specific requirements and challenges. It will be a great introduction for people interested in attending the CORBEL Quality Management Exchange of Experience Workshop which will take place on June 18-19, 2018 in Freising, Germany, organised by the INFRAFRONTIER GmbH. Alternatively, the webinar is a stand-alone introduction to quality management with an emphasis on distributed Research Infrastructures.
CORBEL (http://www.corbel-project.eu) is an initiative of eleven new biological and medical research infrastructures (BMS RIs), which together will create a platform for harmonised user access to biological and medical technologies, biological samples and data services required by cutting-edge biomedical research. CORBEL will boost the efficiency, productivity and impact of European biomedical research.
This webinar took place on 22nd May 2018 and is part of the CORBEL webinar series. A recording of the webinar is available through the CORBEL website:
http://www.corbel-project.eu/webinars/quality-management-in-distributed-research-infrastructures.html
For previous and upcoming CORBEL webinars see:
http://www.corbel-project.eu/webinars
Making Value-Based Healthcare in Cataract a Reality Insights from VBHCAT Pr...Alexandre Lourenço
Alexandre Lourenço's keynote on "Making Value-Based Healthcare in Cataract a Reality - Insights from VBHCAT Project in Portugal", at the 44th World Hospital Congress organized by the International Hospital Federation, in November 8th 2021.
Global Regulatory Issues: one BA method, one validation, one report ...Peter van Amsterdam
Comparison of the recent guidelines of the Brazilian, European, Japanese and US regualtory agencies on bioanalytical method validation in order to be able to validate a bioanalytical method in such a way that it would meet the requirements of these 4 agencies. Presented at the 2013 Land O'Lakes meeting
POINT-of-IMPACT testing. A European perspective - Bert NiestersWAidid
At SoGat meeting 2019 Bert Niesters - Professor in Molecular Diagnostic in Clinical Virology, Medical Molecular Microbiologist at University Medical Center Groningen, Department of Medical Microbiology, Division of Clinical Viroloy, The Netherlands - has talked about the developing trends in molecular diagnostics and the impact on the Laboratory.
To learn more, please visit www.waidid.org!
Roundup of This Year's AACC Meeting in AtlantaBruce Carlson
The American Association of Clinical Chemistry was held this year in Atlanta, GA. Kalorama was at the meeting and notes several developments, with a particular focus on point-of-care.
Prof Clive Badman OBE
Presentation at EIPG - Royal Pharmaceutical Society Scientific Symposium "Advances in Technology Impacting the Pharmaceutical Industry" at the University of Strathclyde, Glasgow 2015.
Point-of-Need Testing: Application of Microfluidic Technologies - 2018 Report...Yole Developpement
Decentralized testing is now widespread, thanks to the endless possibilities enabled by microfluidic technologies.
More information on that report at https://www.i-micronews.com/report/product/point-of-need-testing-application-of-microfluidic-technologies.html
R&D, Competition and Diffusion of Innovation in EU: The Case of Direct Acting...Office of Health Economics
Mikel Berdud, PhD (Office of Health Economics) discussed on the role of incentives for Pharmaceutical innovation (with especial attention to IP rights) and in-patent competition on facilitating access to DAAs across European countries. Other factors affecting access to DAAs in European countries beyond incentives for R&D and market competition were also discussed in the presentation.
Author(s) and affiliation(s): Mikel Berdud (Office of Health Economics) Martina Garau (Office of Health Economics) Margherita Neri (Office of Health Economics) Phill O’Neill (Office of Health Economics) Chris Sampson (Office of Health Economics) Adrian Towse (Office of Health Economics)
Project funded by: Gilead Sciences Ltd.
Conference meeting: XXXVII Jornadas de Economía de la Salud
Location: Auditorio Alfredo Kraus, Las Palmas de Gran Canaria, Canarias, Spain
Date: 20/06/2018
Similar to Pierre yves biomnis presentation national healthcare conference 24th march 2011 (20)
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.
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- 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
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
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
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NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
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
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
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the 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 lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
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. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Novas diretrizes da OMS para os cuidados perinatais de mais qualidade
Pierre yves biomnis presentation national healthcare conference 24th march 2011
1. The Biomnis Group National Healthcare Conference Burlington Hotel, March 24th 2011 Pierre-Yves Guiavarch, President & CEO Simon Chipperfield, International Director Réunion mensuelle DSC - BIOMNIS 15/09/2009
82. Rebates to Public Hospitals (for up to 50% of the standard tariff) are being cancelled over 3 year period
83. Private sector has rapidly started to consolidate in the Town Labs sector
84. Combination of laboratories into regional clusters with hub and spoke model - 1 major lab technical platform and multiple collection centres2. Pathology Reform in France – At a Crossroads www.biomnis.com
92. Whilst ensuring that clinical pathology remains a medically delivered service for the benefit of the patients2. Pathology Reform in France – At a Crossroads www.biomnis.com
107. 65 year olds account for x6-9 more lab tests per head
108. It is estimated that pathology testing in US will increase c.90% by 2017In countries with ageing populations, there will be considerable pressure on Diagnostic Laboratory services due to ageing populations and an increasing reliance on pathology diagnostics www.biomnis.com
109.
110. Greater use of automation and larger technical platforms
120. Staff shortages in medical science disciplines will drive need to change working practices
121. Automation and scaling of technical platforms can enable volume to be delivered at lower cost
122. We can learn from a number of international experiences and models already delivering rapid, high quality results that help clinicians diagnose, treat and monitor patient illnesses and diseaseswww.biomnis.com