With an established regulatory environment and a strong healthcare infrastructure, Latin America continues to grow as an advantageous landscape for conducting clinical research. Join Medpace experts Anibal Calmaggi, MD, Senior Medical Director, Infectious Diseases and Vaccines, and Wanda Dobrzanski, MD, Director Clinical Operations, Pediatric infectious diseases and Pharmaceutical medicine specialist, as they share their collective 36 years of experience in designing and managing clinical research in Latin America.
This presentation discusses:
• Advantages and benefits of running trials in Latin America
• Challenges and strategies for addressing them
• Required procedures and processes
• An in-depth look at the most significant Latin American countries for conducting clinical research
Clinical research in Latin America: constraints and opportunitiesCER Clinical Trials
The number of patients enrolled in international multi-centre clinical trials has increased in some countries of Latin America. Eduardo Gotuzzo, M.D. FACP
Drug manufacturers are looking to emerging markets like Latin America to fuel long-term success.
View this PAREXEL Consulting presentation to learn more.
Clinical research in Latin America: constraints and opportunitiesCER Clinical Trials
The number of patients enrolled in international multi-centre clinical trials has increased in some countries of Latin America. Eduardo Gotuzzo, M.D. FACP
Drug manufacturers are looking to emerging markets like Latin America to fuel long-term success.
View this PAREXEL Consulting presentation to learn more.
Please share this webinar with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
In this webinar:
● Primer for attendees attending the November 15-16 Drug Pricing Policy Summit
● Broad conceptual blueprint of federal and provincial/territorial public health policy structures across Canada
● Description of legal frameworks, government responsibility centres and their mandates for treatment access, with reference to specific opportunities for patient engagement
View the video: https://youtu.be/X9AB70om-Dw
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Market access database with more than 2,000 reports that provide companies with a roadmap regarding the steps to follow to succeed in the Spanish market
Clinical evidence for medicinal cannabis reportRoby Zomer
A Report Developed by the University of Sydney
Community Placement Program in Partnership with
MGC Pharmaceuticals, In recent years, medicinal cannabis has gone from being a niche and obscure area of medical scientific research into “one of the fastest moving frontiers in pharmacology”.
The potential value of cannabis as medicine has been demonstrated in relation to a number of serious conditions and symptoms including cancer, epilepsy, multiple sclerosis, chronic pain, muscle spasticity and nausea. The clinical evidence regarding medicinal cannabis has received less attention
than it merits, and scientists, clinicians, patients and carers seeking access to this evidence have found it difficult to separate good research from the wealth of anecdotal and less rigorously obtained experimental results. This report aims to summarise the strongest available scientific research on the use of cannabis as a
medicine for the treatment of epilepsy, cancer and multiple sclerosis; the symptoms of these conditions; and the side-effects of their current treatment.
Orphan Drugs – the Challenges and Benefits of Navigating FDA’s Regime Governi...Michael Swit
Webinar sponsored by The Weinberg Group on Orphan Drugs, covering these topics:
The Basics of the Orphan Drug Act
Benefits of Orphan Drug status
Exclusivity
Protocol assistance, tax credits, and research grants
When is an indication is “rare”?
Orphan Drug Designation Requests – ensuring yours
robust and persuasive
Approval criteria for orphan products – how they
compare to non-orphan products
Challenges in the Orphan Drug Process
The orphan drug area is relatively new but fast growing. Over the next weeks, Black Swan Consulting will summarise information on this class of drug products. Please also see http://black-swan-consulting.com/what-is-cooking/Orphan-drugs.
Connecting the Dots for Fast-Track Approval for Rare Disease and Orphan DrugMedpace
Managing a rare disease or orphan drug clinical trial has several challenges. Be prepared to understand and take away real world tactical lessons to expedite these studies:
•What are the new promising techniques in clinical studies for Rare Disease research? How are the innovative areas of adaptive strategies and translational medicine being employed?
• How do patient registries and natural history studies provide insights and patients for these studies?
• What quality of life issues play into patient retention in these studies?
• How can regulatory challenges from submissions to drug approvals be met using integrated global knowledge and systems to keep a project on track?
Over 30 years after the Orphan Drug Act was passed, orphan drugs continue to be a lucrative market for pharma companies. Although orphan diseases affect small populations, these treatments address a high unmet need and also benefit from commercially attractive pricing structures and additional regulatory benefits.
Full graphic: http://www.isrreports.com/free-resources/5408/
Please share this webinar with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
In this webinar:
● Primer for attendees attending the November 15-16 Drug Pricing Policy Summit
● Broad conceptual blueprint of federal and provincial/territorial public health policy structures across Canada
● Description of legal frameworks, government responsibility centres and their mandates for treatment access, with reference to specific opportunities for patient engagement
View the video: https://youtu.be/X9AB70om-Dw
Follow our social media accounts:
Twitter - https://twitter.com/survivornetca
Facebook - https://www.facebook.com/CanadianSurvivorNet
Pinterest - https://www.pinterest.com/survivornetwork
YouTube - https://www.youtube.com/user/Survivornetca
Market access database with more than 2,000 reports that provide companies with a roadmap regarding the steps to follow to succeed in the Spanish market
Clinical evidence for medicinal cannabis reportRoby Zomer
A Report Developed by the University of Sydney
Community Placement Program in Partnership with
MGC Pharmaceuticals, In recent years, medicinal cannabis has gone from being a niche and obscure area of medical scientific research into “one of the fastest moving frontiers in pharmacology”.
The potential value of cannabis as medicine has been demonstrated in relation to a number of serious conditions and symptoms including cancer, epilepsy, multiple sclerosis, chronic pain, muscle spasticity and nausea. The clinical evidence regarding medicinal cannabis has received less attention
than it merits, and scientists, clinicians, patients and carers seeking access to this evidence have found it difficult to separate good research from the wealth of anecdotal and less rigorously obtained experimental results. This report aims to summarise the strongest available scientific research on the use of cannabis as a
medicine for the treatment of epilepsy, cancer and multiple sclerosis; the symptoms of these conditions; and the side-effects of their current treatment.
Orphan Drugs – the Challenges and Benefits of Navigating FDA’s Regime Governi...Michael Swit
Webinar sponsored by The Weinberg Group on Orphan Drugs, covering these topics:
The Basics of the Orphan Drug Act
Benefits of Orphan Drug status
Exclusivity
Protocol assistance, tax credits, and research grants
When is an indication is “rare”?
Orphan Drug Designation Requests – ensuring yours
robust and persuasive
Approval criteria for orphan products – how they
compare to non-orphan products
Challenges in the Orphan Drug Process
The orphan drug area is relatively new but fast growing. Over the next weeks, Black Swan Consulting will summarise information on this class of drug products. Please also see http://black-swan-consulting.com/what-is-cooking/Orphan-drugs.
Connecting the Dots for Fast-Track Approval for Rare Disease and Orphan DrugMedpace
Managing a rare disease or orphan drug clinical trial has several challenges. Be prepared to understand and take away real world tactical lessons to expedite these studies:
•What are the new promising techniques in clinical studies for Rare Disease research? How are the innovative areas of adaptive strategies and translational medicine being employed?
• How do patient registries and natural history studies provide insights and patients for these studies?
• What quality of life issues play into patient retention in these studies?
• How can regulatory challenges from submissions to drug approvals be met using integrated global knowledge and systems to keep a project on track?
Over 30 years after the Orphan Drug Act was passed, orphan drugs continue to be a lucrative market for pharma companies. Although orphan diseases affect small populations, these treatments address a high unmet need and also benefit from commercially attractive pricing structures and additional regulatory benefits.
Full graphic: http://www.isrreports.com/free-resources/5408/
Brazil International Ltd. is a boutique company that provides business
services for companies in the medical device field, seeking to
successfully penetrate and participate in the Brazilian market.
Changes in device classification under the EU Medical Devices and In Vitro Di...Erik Vollebregt
Presentation at the Q1 Intensive MDR/IVDR Readiness
and Transition Management Workshop about classification changes under the EU Medical Devices and In Vitro Diagnostic Regulation
Strategies for Device Approval in China, India, South Korea and AustraliaApril Bright
This session will describe the orthopaedic device regulatory and registration requirements in Asia Pacific markets. Regulatory steps and strategies will be presented for each of these countries. The discussion will also cover ways to gain regulatory information about competitors already selling in these markets. Attendees will leave the session with an understanding of timelines, costs and complexity for approval.
Steps to Compliance with the European Medical Device RegulationsApril Bright
The trilogue negotiations for the European Medical Device Regulations are expected to conclude by June. Whether or not the long-awaited regulations receive another postponement, orthopaedic manufacturers cannot put off preparation or they risk their ability to sell products in Europe. Dr. Tariah will walk attendees through the greatest pain points for orthopaedic manufacturers when complying with the new regulations.
In Latin America, cancer and its control present often stark contrasts—or, in the words of one expert interviewed for this study, “light and shadow”. Rapid change occurs next to stubborn stasis, and substantial progress in some areas is intermingled with still unmet, pressing needs in others.
It is also an issue with growing political salience within the region: past success in the control of communicable diseases has increased the relative profile of non-communicable ones.
This study looks in detail at both the bright spots and the ongoing gaps for Latin American governments as they wrestle with cancer and seek to provide accessible prevention and care to their populations. Its particular focus is on 12 countries in Central and South America chosen for various factors, including their size and level of economic development. These states, referred to as “study countries”, are Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Panama, Paraguay, Peru and Uruguay. Together they accounted for 92% of cancer incidence and 91% of mortality in Central and South America in 2012.
The study also introduces a major tool for stakeholders seeking to understand this field: the Latin America Cancer Control Scorecard (LACCS). The LACCS relies on significant desk research to rank the 12 study countries on their performance in different areas of direct relevance to cancer-control access. In addition to the scorecard, the report also draws on its own, separate substantial research as well as 20 interviews with experts on cancer in the region and worldwide. Its key findings include the following.
This report examines the burden of lung cancer in Latin America and how well countries in the region are addressing the challenge. Its particular focus is on 12 countries in Central and South America, chosen for various factors including size and level of economic development: Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Panama, Paraguay, Peru and Uruguay.
May 19: Leave No One Behind
Panelists
Brad Alyward, Head Market Access & Health Policy, Indivior
Catherine Boivin, Patient Advocate, CORD
Shona Kinley,Director, Federal Policy & Government Affairs, Novartis
Bennett Lee, Head, Value & Access, Sanofi
Joan Paulin, Patient Advocate, PHA Canada
Trevor Richter, Director of Access and Reimbursement, Gilead
Please share this video with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
In this webinar:
● Takeaways from a roundtable held on June 1st about patient-centred pharmacare in Canada
● Reports from patient groups and other subject matter experts
● A cohesive vision and set of values for national pharmacare in Canada
View the video: https://youtu.be/HMy_gsTDkfI
Follow our social media accounts:
Twitter - https://twitter.com/survivornetca
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Webinar: Oncology Trial Recruitment: Challenging Indications and Challenging ...Medpace
Medpace experts discuss how to overcome oncology recruitment challenges for clinical trials for specific populations, indications, and challenging studies.
Closing the treatment gap in alcohol dependence thessalonika 2015Antoni Gual
Lecture on the treatment gap (underdiagnose & undertreatment) of alcohol use disorders. Presented at the 5th Conference of the Greek Psychiatric society in Thessalonika, march 21st, 2015.
The intensifying global focus on oncology reflects its increasing impact on patients and expanding share of healthcare expenditure. Relative to other parts of the healthcare system, oncology brings high levels of uncertainty—in terms of the nature and rate of innovative treatments, the willingness by payers to reimburse care at current levels, and the shifting composition of the cancer patient population from mature and developed markets to low- and middle-income countries. As the sales of cancer treatments rise to $100 billion annually, more intensive scrutiny of this market can be expected and a deeper understanding of global oncology trends will be required by all stakeholders.
How general internists can participate in the continuum of care for patients with cancer. (Talk given at Internal Medicine Grand Rounds, St. Elizabeth Hospital, General Santos City, 10 Feb 2021.)
Wielding the Double-Edge Sword of Cardiac Biomarkers in Clinical Trials: A Di...Medpace
Learn best practices for utilizing cardiac biomarkers across various components of a clinical trial from Dr. James Januzzi, a leading expert in cardiovascular biomarkers.
Avoiding Common Pitfalls in Cell and Gene Therapy TrialsMedpace
Our experts will dive into case studies explaining the issues that arose with past projects, and how these studies got back on track. The knowledge gained from these experiences accelerate CGT development by avoiding potential pitfalls and getting ahead of regulatory and operational issues. Our team will walk you through the delays associated with these pitfalls and how to avoid them.
Considerations for the Next Wave of COVID-19 DevelopmentMedpace
What did we learn from the first wave of COVID-specific studies that can be applied to those studies that will follow? Medpace has gathered some of its medical and operational team experts who have been on the front-line in designing and conducting trials for SARS-CoV-2 to answer some frequently asked questions, trends they see emerging and considerations for future development.
COVID-19 Product Development and Clinical Trials: Considerations from Europea...Medpace
Join experts from Medpace’s regulatory and operational teams in this webinar as they provide insights and considerations on how to accelerate product development for COVID-19 during different stages
Part 3: Rare Disease Clinical Development – Strategies for Ensuring Endpoint ...Medpace
n this free webinar, Medpace partners with Michelle Eagle of ATOM International, a provider of CE training for clinical trials across the world, to discuss approaches and steps that can be taken to ensure quality and integrity.
Getting Ahead of the Evolving Landscape in RadiopharmaceuticalsMedpace
In this webinar devoted to radiopharmaceuticals, the featured speakers will explore the scientific, operational and regulatory considerations for radiopharmaceuticals. With a focus on oncology, they will discuss the current regulatory landscape and how this impacts overall development programs. The speakers will explore the challenges of conducting radiopharmaceutical trials, offering insights into trial start-up, site selection and operational aspects to seamlessly execute these studies as part of clinical development plans.
Challenges and Considerations in Clinical Development of "Targeted Therapies"...Medpace
In this webinar, Medpace experts discuss key clinical, operational and laboratory considerations, lessons-learned, and best practices for accelerating the global development of safe and effective targeted therapeutics, using acute myeloid leukemia (AML) to highlight the complexities.
The RACE for Children Act Will Change the Landscape for Pediatric Cancer Rese...Medpace
In this webinar, we explore the regulatory implications of the RACE for Children Act and what this law means for your development program, particularly with navigating the change in requirements for pediatric oncology trials. Furthermore, we explore the challenges of executing oncology trials in pediatric populations and offer insight into design and operational aspects to seamlessly execute these studies as part of your clinical development plan
Identifying High Performing Sites and Engaging PatientsMedpace
One of the biggest challenges facing any clinical trial is how to identify the sites with the greatest potential to engage and retain patients. Applying decades of experience to the topic, Medpace experts will share considerations, lessons-learned and best practices for developing patient recruitment strategies to put you on the path for optimal success.
Challenges and Considerations in Designing and Conducting Immuno-Oncology Cli...Medpace
Given the accelerating pace of immuno-oncology clinical research, awareness of the specific challenges and considerations in designing and conducting successful trials for these new agents is critical.
What Happens After Your Device is Approved? Collecting Data in the Real WorldMedpace
In this workshop, Medpace will discuss key considerations for generating real-world evidence and how to apply critical insights in order to drive late-stage clinical research. To listen to this presentation, visit https://vimeo.com/168768256
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.
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.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
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
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
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.
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
2 Case Reports of Gastric Ultrasound
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Latin America: Challenges & Opportunities in Clinical Research
1. Latin America Review
o Wanda Dobrzanski
Nisiewicz M.D.
o Director
o March 2016
LATIN AMERICA:
Challenges &
Opportunities in
Clinical Research
HOST:
James Pusey, M.D.
Senior Vice President, Clinical Operations
PRESENTERS:
Wanda Dobrzanski, M.D.
Head of Clinical Operation Latin America
Anibal Calmaggi, M.D.
Senior Medical Director,
Infectious Diseases and Vaccines
2. South America
Central America
Caribbean
22 independent countries +
France, Netherlands and U.S.
dependencies
Population ~ 600 million
Latin America Overview
Physician Led | Therapeutically Focused2
3. Latin America – Clinical Trials by Region
3 Physician Led | Therapeutically Focused
Source: clinicaltrials.gov
as of March 2015
4. Benefits of Performing Clinical Trials
o Growing population: ~ 620 million people, 80% in
urban areas
o Qualified, reliable and committed medical
professionals. Physicians with more time to
dedicate to clinical studies
o Strong patient-doctor relationship
o Significant availability of naïve patients (both
treatment and trial naïve)
Latin America
Physician Led | Therapeutically Focused4
5. Benefits of Performing Clinical Trials
o Incidence/prevalence of certain diseases similar
or higher than the U.S.
o Centralized health-care. Mexico City, (Mexico),
Sao Paulo (Brazil), Buenos Aires (Argentina) and
Rio de Janeiro (Brazil) have together a population
>60 million people
Allows higher enrollment rates in fewer sites
o A significant portion of the population <14 years
old (27%)
o Ethnic diversity covering most of the world's
population
Latin America
Physician Led | Therapeutically Focused5
6. Benefits of Performing Clinical Trials
o Reverse seasons
o Established regulatory environment in most of the
countries
o Data quality within the average of the industry
o Regular inspections by MoH in certain countries
o Spanish and Portuguese as unique languages
o Competitive costs
Latin America
Physician Led | Therapeutically Focused6
7. Why Subjects Participate in Clinical Trials
o Zero cost of treatment
o “Modern” medication / evaluations
o Respect for their doctor
o Positive status in the community / family
o Differentiated treatment by hospital staff
o Satisfaction on inner needs: valued, appreciated,
listened to, reassured, approved and
acknowledged
o Altruistic feeling
o Benefit perceived in the family for disease
education
Latin America
Physician Led | Therapeutically Focused7
8. Getting Epidemiological Information from
LA
8 Physician Led | Therapeutically Focused
o There is a lack of comprehensive epidemiological data for the
Latin
o American countries in some therapeutic areas. Main reasons:
Non-mandatory reportability to the Health authorities
Difficulties to conduct epidemiological research in resource-poor
settings
Chronic nature of many diseases, multiple causes and correlated
morbidity.
More data systematically collected for some conditions that require
hospitalization, such as cancer
Most of the available data is concentrated in the larger economies,
such as Brazil, Mexico, and Argentina. The smaller economies in this
region, such as Peru and Colombia, are largely neglected, and the
epidemiological information is poor for some diseases
• Epidemiological available information must be confirmed, updated and
complemented with data obtained from feasibility studies, studies published
in local language, Minister of Health special reports, enrollment rates from
previous similar studies, etc.
• This search should be approached by a local team as a routine work for
every potential study to be conducted in LA
9. Cardiovascular and Metabolic Disease Trends in LA
o Cardiovascular diseases are the leading cause of death in LA,
with ischemic heart disease as the principal cause in most
countries
o The adaptation to occidental life styles in LA countries has given
rise to an increase in the prevalence of overweight, abdominal
obesity, smoking, hypertension, metabolic syndrome, diabetes
mellitus type 2 and cardiovascular diseases
o Smoking prevalence is still unacceptably high in the region.
Prevalence rates of smoking (defined as having smoked >100
cigarettes and currently smoking) range from 12.8% in Colombia,
15.5% in Brazil, 19.9% in Mexico, up to 32.7% and 33.4% in
Uruguay and Argentina, and as high as 42% in Chile
o Hypercholesterolemia and hypertension are the two most
common cardiovascular risk factor across the LA region. The
increasing prevalence of diabetes is forecast to become
considerably significant in the epidemiology of cardiovascular
disease
A summary
Physician Led | Therapeutically Focused9
10. Oncology Trends in Latin America
o The epidemiological information on cancer in LA originates mainly from
mortality registries and from a limited number of population-based
cancer registries that present reliable data. Therefore, incidence data
are still limited to specific populations
o The patient pool for cancer therapies is rising in LA, a trend primarily
driven by the rising life expectancies across the populations
o Prostate cancer is the most common malignancy developed by men,
and is the second leading cancer-related cause of death in men,
surpassed only by lung cancer
o Lung cancer is the second more frequent malignancy in men. It is
responsible for the greatest number of cancer-related deaths in this
population
o Breast cancer is the most common form of cancer developed by women
and also the leading cause of cancer-related mortality for woman
o Colorectal cancer is the fourth most commonly developed cancer in LA,
after prostate, breast, and uterine cancers. In line with the average age
of the population, colorectal cancer is expected to rise over the forecast
years
A summary
Physician Led | Therapeutically Focused10
Source: 2014 Icahn School of Medicine at Mount Sinai. Annals of Global Health 2014;80:370-377
11. Other Therapeutic Areas with High
Prevalence in Specific Diseases
11 Physician Led | Therapeutically Focused
o Infectious diseases
Endemic: TB, dengue, malaria, zika
High prevalence of antimicrobial resistance rates
(carbapenem resistant enterobacteriaceae, HA-
MRSA and CA-MRSA, Acinetobacter spp and P.
aeruginosa MDR)
o Respiratory diseases: COPD, asthma, allergic
rhinitis
o Neurologic diseases: multiple sclerosis, Parkinson
disease, epilepsy, stroke
o Mental disorders: schizophrenia, bipolar disorder,
depression, panic disorder
12. Strong enrollment rates, higher
patient-compliance and retention
Drop-out rates 50% lower than
other regions
13. Challenges to Performing Clinical Trials
o Social, economic or politically volatile environment
in some countries
o Clinical trial regulations in LA are still evolving in
some countries
o Regulatory timelines longer than in the US
o Logistical issues:
Regional/Central laboratories (restriction on some
days of the week)
Custom clearances process in each country to
import/export supplies
Latin America
Physician Led | Therapeutically Focused13
14. Overcoming Challenges
14
o Plan to start with Latin American countries from
the very beginning of the project
o Perform feasibility activities
o Diversify the risk by adding an appropriate
number of countries
o Rely on local knowledge and expertise
o Evaluate potential rather than experience
Physician Led | Therapeutically Focused
15. Special Requirements and Tips
o Study documents translation into Portuguese for
Brazil and Spanish for the rest of the countries for
initial submission
o ICF adaptation according to country-specific
requirements
o Notarized transfer of responsibility letters
(delegating submissions/ conduct of the study to the
CRO)
o Global insurance certificate for all countries and
local insurance issued by national insurance company
for Costa Rica
o Labels in local language and including local
requirements
Working in Latin America
Physician Led | Therapeutically Focused15
16. Import Process and Logistics
o Licenses needed for study drugs, devices, lab
kits (in some countries also export permit is
needed for biological samples)
Complete list of all goods to be imported (and
exported) at the begining of the submission process
o Customs clearance process involved in all LA
countries
o Local depot per country is highly recommended
for storage and distribution
o Requirement for each import event:
Pro-forma invoices to be reviewed in advance
Air way bills number needed in advance
Physician Led | Therapeutically Focused16
17. Argentina
Population distribution
17 Physician Led | Therapeutically Focused
Norte
5,795,363
14.4%
Mesopotamia
6,524,719
16.3%
Centro
22,575,372
56.3%
Argentina total: 40,117,096
Patagonia
2,100,188
5.2%
Cuyo
3,121,454
7.8%
18. Renewed Regulatory Commitment
o “ANMAT declares that it adopts a
proactive position to boost the
development of clinical research”
o “Supporting clinical research,
ANMAT is actively working to
update and improve the
evaluation process guidelines,
without relaxing the requirements
for population protection,
especially of the people included
in the study. Besides, it aims at
increasing the collaboration with
other government bodies”
March 2016
Physician Led | Therapeutically Focused18
19. Total population: 202 768 562
North 17 231 027 8,5%
North East 56 560 081 27,9%
Middle West 15 219 608 7,5%
South East 85 115 623 42,0%
South 29 016 114 14,3%
Source: IBGE - Censo Demográfico – Estimative in 2014
Brazil’s Potential
Brazil population distribution
Physician Led | Therapeutically Focused19
43.7%
56.3%
Norte
Nordeste
Centro-Oeste
Sudeste
Sul
20. Perspectives of Changes
Aim: expedite regulatory approvals in Brazil
o Implementation of an accreditation process of
research ethics committees composing the system
CEP/CONEP –Q3/2016 after EC trainings
o Implementation of a resolution to analyze study
protocols according to risk defined by study design
o Minimum risk & Low Risk protocols , only notification
needed or fast track
o Moderate & High Risk protocols, EC approval required
Brazil regulatory environment in 2016 – under discussion
Physician Led | Therapeutically Focused20
21. Chile
Population distribution
21
XV
XII
XI
X
XIV IX
VIII
VII
RM
VI
V
IV
III
II
I
Nº Región Numero %
XV Arica y Parinacota 213,816 1.3%
I Tarapaca 300,021 1.8%
II Antofagasta 547,463 3.3%
III Atacama 292,054 1.8%
IV Coquimbo 707,654 4.3%
V Valparaiso 1,734,917 10.4%
RM Metropolitana 6,685,685 40.2%
VI O’higgins 877,784 5.3%
VII Maule 968,336 5.8%
VIII Bio Bio 1,971,998 11.9%
IX La Araucania 913,065 5.5%
XIV Los Rios 364,592 2.2%
X Los Lagos 798,141 4.8%
XI Aysen 99,609 0.6%
XII Magallanes 159,468 1.0%
Total Chile 16,634,603 100%
Población por Regiones Censo 2012
Fuente: Sintesis de Resultados Censo 2012
Physician Led | Therapeutically Focused
22. Chile
o Reliable timelines: 4-5 months/16-20 weeks from
initial submission
o Each site submits to their local ethic commitee
(there is no central IRB in Chile)
o Short timelines for studies involving Medical
Devices (MD): 8 weeks from initial submission
o Chilean sites
Highly qualified medical personnel and experienced
investigators
Excellent patient recruitment and retention
Experienced on pediatric studies
Strengths & Success factors
22 Physician Led | Therapeutically Focused
23. Total population: 112,336,538
From 7,643,195 to 15,175,862
From 5,779,830 to 7,643,194
From 3,801,963 to 5,779,829
From 1,955,578 to 3,801,962
From 637,026 to 1,955,577
Mexico
Population distribution
Physician Led | Therapeutically Focused23
INEGI Instituto Nacional de Estadística y Geografía.
Censo de Población y Vivienda 2010
25. Coverage of Other Countries
25 Physician Led | Therapeutically Focused
Peru
Panama
Columbia
Guatemala
26. Conclusion
o Highly-motivated and experienced investigators with
availability to recruit subjects in a variety of
therapeutic areas
o The increasing number of clinical research activities in
Latin America is facilitating the outsourcing of trials to
the region
o Political environment has started to stabilize and
significant economic development occurs
o Healthcare has improved and centers with personnel
trained in clinical research have increased
o National clinical trial regulations aligned with
international good clinical practices have been
established
Physician Led | Therapeutically Focused26
27. Conclusion
o Latin America shows a less competitive
landscape, favorable cost, language capabilities,
and robust quality data
o This can help pharmaceutical and biotechnology
companies speed up drug development process
Physician Led | Therapeutically Focused27
28. Q & A
Wanda Dobrzanski, M.D.,
Head of Clinical Operation Latin America
v.dobrzanski@Medpace.com
Anibal Calmaggi, M.D.,
Senior Medical Director,
Infectious Diseases and Vaccines
a.calmaggi@Medpace.com
29. Q & A Session
29 Physician Led | Therapeutically Focused
o Please clarify what you mean by low/medium risk
studies will only require a notification. Do you
mean that low/medium treatment risk protocols
will only require approval from the LEC with a
notification to CEC (CONEP)?
o Who will determine the protocol risk?
o Once this process is fully implemented, what will
be the expected approval timelines in Brazil?
30. Q & A Session
30 Physician Led | Therapeutically Focused
o You mentioned that ANMAT has declared a
proactive position to boost the development of
clinical research by working to update and
improve the evaluation process guidelines and by
increasing the collaboration with other
government bodies. In practical terms, what has
this changed?
o Will these changes expedite regulatory approvals
in Argentina?
31. Q & A Session
31 Physician Led | Therapeutically Focused
o You mentioned that Political environment has
started to stabilize and significant economic
development is occurring. Can you clarify what
countries you are referring to?
32. Q & A Session
32 Physician Led | Therapeutically Focused
o Regarding Rare diseases, do you have any fast
track process to approve these studies?
o In Metabolic and Diabetes, do you have previous
experience to share from Latin America?
33. Q & A Session
33 Physician Led | Therapeutically Focused
o You mentioned in the presentation that data
quality is within the average of the industry.
However, what were the results of the FDA audits
performed in Latin America?
What countries were audited?
34. Q & A Session
34 Physician Led | Therapeutically Focused
o During your presentation you just mentioned
about the epidemiology for infectious disease,
cardiology & metabolic diseases and oncology.
Which are the diseases with bigger incidence and
prevalence in Latin America?
o Are there potential sites in the Latin American
region to work with endocrine disorders such as
Diabetes, Acromegaly and Cushing disease?
35. Q & A Session
35 Physician Led | Therapeutically Focused
o Some sponsors select LatAm as rescue countries
to be included in the study, do you think this
strategy could be used for the countries in the
region?
36. Q & A Session
36 Physician Led | Therapeutically Focused
o Which are the new proposed timelines for
approvals after the changes in the regulatory
environment for the Argentina and Brazil take
place? How many months do you think it will take
to have the final approval released in these
countries?
37. Q & A Session
37 Physician Led | Therapeutically Focused
o Which recruitment strategies are most commonly
used in the region? How does the countries find
their study subjects?
38. Q & A Session
38 Physician Led | Therapeutically Focused
o Could you please further explain about your
centralized health-care system in the region? Is
there a central database available for subjects’
enrollment?