Latin America: Challenges & Opportunities in Clinical ResearchMedpace
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
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.
Increasing access to medicines, presentation by Edith Andrews Annan of World Health Organization (WHO) during the MeTA Ghana, CSO & media orientation workshop, 16 April 2009.
August 2, 2014 presentation to the Orange County Regulatory Affairs (OCRA) Discussion Group Regulatory Affairs Certification (RAC) Review Course, with a focus on:
• History of FDA
• Overview of US Legal System
• General Structure of FDA
• FDA Definitions
Latin America: Challenges & Opportunities in Clinical ResearchMedpace
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
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.
Increasing access to medicines, presentation by Edith Andrews Annan of World Health Organization (WHO) during the MeTA Ghana, CSO & media orientation workshop, 16 April 2009.
August 2, 2014 presentation to the Orange County Regulatory Affairs (OCRA) Discussion Group Regulatory Affairs Certification (RAC) Review Course, with a focus on:
• History of FDA
• Overview of US Legal System
• General Structure of FDA
• FDA Definitions
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
Online Access to Safe and Affordable Medication: Applying human rights law to...PharmacyChecker
Online Access to Safe and Affordable Medication: Applying human rights law to cyber rule-making and Internet governance
https://www.pharmacychecker.com/
Internet users are benefiting from online access to safe and affordable medications. The pharmaceutical industry views Internet access as a threat and disruptive to its profit model because consumers are paying less than the drug companies intended for them to pay. According to the UN Human Rights Council, access to affordable medication is a human right. As the Internet community seeks to infuse the principles of international human rights law into the discourse and practice of Internet governance it should help maintain the widest possible online access to safe and affordable medication.
https://www.pharmacychecker.com/
T-Cell Immunotherapy Pipeline Analysis 2016 by P&S Market ResearchAryan Mishra
The study analyzed that the T-cell immunotherapy pipeline comprised of 139 therapeutic candidates, of which 16 are in Phase II stage of development. The high prevalence of cancer across the globe fuels the extensive research and development for the T-cell immunotherapeutic.
These are some frequently asked questions in Pharmacovigilance Interview & its Preparation.
"HANDS IN HANDS LEARNING"
FOR ENROLLMENT-
CONTACT US ON-
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
Chapter 19Clinical Trials Clinical TrialsThe history EstelaJeffery653
Chapter 19
Clinical Trials
Clinical Trials
“The history of the last 20 years is one of crises with drugs and medical devices, many approved despite the objections of the FDA’s own scientists.”
— Sidney M. Wolfe
Lecture Overview
Research and Development Investments Fund a Complex Multistage Pathway
Clinical Trials of Generic Drugs
Health Risk Assessments
Expanded Access Protocols
Termination of Clinical Trials
Observational Studies
International Clinical Trials
Informed Consent in General
Transparency and Full Disclosure in Clinical Testing
Financial Conflicts of Interest
Commitment to the Life Sciences
Source: Hammaker, D. K., & Knadig, T. M. with Tomlinson, S.J. (2017). Clinical trials. In Health care management and the law: Principles and applications (pp. 389-412). (2nd Ed.) Burlington, MA: Jones & Bartlett Learning.
Research and Development Investments Fund a Complex Multistage Pathway
Some major expenses are research materials, advanced computers, and other highly sophisticated machines that support research activities, and salaries of scientists. Stage specific activities include:
Drug discovery
Preclinical testing
Clinical trials
Approval by the FDA
Post marketing surveillance
Research and Development Investments Fund a Complex Multistage Pathway
Drug Discovery:
While most compounds will never be approved for use, each one is evaluated to determine its potential value compared to existing therapies, complexity of large scale manufacturing, and other factors.
Preclinical Testing:
Candidate drugs from the discovery stage receive 1 to 3 years of extensive testing to assess safety and show biological activity against a disease.
Chemical tests establish the purity, stability, and shelf life of a compound.
Manufacturing tests determine mass production of the drug.
Pharmaceutical development studies explore dosing, packaging, and formulation of the drug.
Research and Development Investments
Fund a Complex Multistage Pathway: Clinical Trials
For drugs in development, there are low odds of reaching the market.
While Phase I, II, and III of studies are taking place, research investigators are also conducting toxicity tests and other long-term safety evaluations, evaluating dosage forms, planning for mass production, designing packaging, and preparing the extensive application required for FDA approval.
One out of five drugs that enter clinical testing is never approved by the FDA:
20% of the drugs that enter Phase I are approved to enter Phase II
30% of the drugs that enter Phase II are approved to enter Phase III
60% of the drugs that enter Phase III are approved for a new drug application
80% of the new drug applications are approved by the FDA for market entry
Research and Development Investments Fund a Complex Multistage Pathway
Approval by the U.S. Food and Drug Administration
According to the FDA, the documentation required in a new drug application is supposed to tell the whole story of a ...
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
Online Access to Safe and Affordable Medication: Applying human rights law to...PharmacyChecker
Online Access to Safe and Affordable Medication: Applying human rights law to cyber rule-making and Internet governance
https://www.pharmacychecker.com/
Internet users are benefiting from online access to safe and affordable medications. The pharmaceutical industry views Internet access as a threat and disruptive to its profit model because consumers are paying less than the drug companies intended for them to pay. According to the UN Human Rights Council, access to affordable medication is a human right. As the Internet community seeks to infuse the principles of international human rights law into the discourse and practice of Internet governance it should help maintain the widest possible online access to safe and affordable medication.
https://www.pharmacychecker.com/
T-Cell Immunotherapy Pipeline Analysis 2016 by P&S Market ResearchAryan Mishra
The study analyzed that the T-cell immunotherapy pipeline comprised of 139 therapeutic candidates, of which 16 are in Phase II stage of development. The high prevalence of cancer across the globe fuels the extensive research and development for the T-cell immunotherapeutic.
These are some frequently asked questions in Pharmacovigilance Interview & its Preparation.
"HANDS IN HANDS LEARNING"
FOR ENROLLMENT-
CONTACT US ON-
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
Chapter 19Clinical Trials Clinical TrialsThe history EstelaJeffery653
Chapter 19
Clinical Trials
Clinical Trials
“The history of the last 20 years is one of crises with drugs and medical devices, many approved despite the objections of the FDA’s own scientists.”
— Sidney M. Wolfe
Lecture Overview
Research and Development Investments Fund a Complex Multistage Pathway
Clinical Trials of Generic Drugs
Health Risk Assessments
Expanded Access Protocols
Termination of Clinical Trials
Observational Studies
International Clinical Trials
Informed Consent in General
Transparency and Full Disclosure in Clinical Testing
Financial Conflicts of Interest
Commitment to the Life Sciences
Source: Hammaker, D. K., & Knadig, T. M. with Tomlinson, S.J. (2017). Clinical trials. In Health care management and the law: Principles and applications (pp. 389-412). (2nd Ed.) Burlington, MA: Jones & Bartlett Learning.
Research and Development Investments Fund a Complex Multistage Pathway
Some major expenses are research materials, advanced computers, and other highly sophisticated machines that support research activities, and salaries of scientists. Stage specific activities include:
Drug discovery
Preclinical testing
Clinical trials
Approval by the FDA
Post marketing surveillance
Research and Development Investments Fund a Complex Multistage Pathway
Drug Discovery:
While most compounds will never be approved for use, each one is evaluated to determine its potential value compared to existing therapies, complexity of large scale manufacturing, and other factors.
Preclinical Testing:
Candidate drugs from the discovery stage receive 1 to 3 years of extensive testing to assess safety and show biological activity against a disease.
Chemical tests establish the purity, stability, and shelf life of a compound.
Manufacturing tests determine mass production of the drug.
Pharmaceutical development studies explore dosing, packaging, and formulation of the drug.
Research and Development Investments
Fund a Complex Multistage Pathway: Clinical Trials
For drugs in development, there are low odds of reaching the market.
While Phase I, II, and III of studies are taking place, research investigators are also conducting toxicity tests and other long-term safety evaluations, evaluating dosage forms, planning for mass production, designing packaging, and preparing the extensive application required for FDA approval.
One out of five drugs that enter clinical testing is never approved by the FDA:
20% of the drugs that enter Phase I are approved to enter Phase II
30% of the drugs that enter Phase II are approved to enter Phase III
60% of the drugs that enter Phase III are approved for a new drug application
80% of the new drug applications are approved by the FDA for market entry
Research and Development Investments Fund a Complex Multistage Pathway
Approval by the U.S. Food and Drug Administration
According to the FDA, the documentation required in a new drug application is supposed to tell the whole story of a ...
Did you know 40-65% of all clinical trials involving FDA-regulated products are being conducted overseas? Time, reduced costs, and easier subject recruitment are the factors that make life science companies to conduct clinical trials overseas.
A Rare International Dialogue (Saturday May 11, 2019)
Drivers of Drug Development – Regulatory Collaboration
Canada’s regulatory approach to drugs for rare diseases - Fiona Frappier, Health Canada
Introduction to Regulatory Affairs - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, June 14, our colleagues Fiorenzo Savoretti, Senior Regulatory and Quality Consultant at Pfizer and Nick Deschacht, Senior RA Consultant at GSK, gave an interesting “Introduction to Regulatory Affairs”.
Fiorenzo and Nick talked about RA and their projects, each from their unique angle. They delivered their presentations for ## attendees at our Brussels office at the Lambroekstraat 5a in Diegem.
Presentation by Chad Kimbler and Carla Tressell. Presented at the 2018 Eyes on a Cure: Patient & Caregiver Symposium, hosted by the Melanoma Research Foundation's CURE OM initiative.
Introduction to disclosures in clinical trials. This presentation provides brief information about types of disclosures, FDAAA (www.clinicaltrials.gov) and EU (EudraCT) portals for clinical trial protocols and result summary disclosures in public domain.
Patient-centered pharmacovigilance represents a pivotal shift in the landscape of healthcare, emphasizing the active involvement of patients in the monitoring and reporting of adverse drug reactions. Unlike traditional pharmacovigilance, which primarily relies on healthcare professionals to identify and document adverse events, this approach recognizes patients as critical stakeholders in ensuring medication safety. By empowering patients to share their experiences, concerns, and observations regarding medication effects, whether positive or negative, healthcare systems can gain a comprehensive understanding of drug safety and efficacy in real-world settings. Patient-centered pharmacovigilance fosters a collaborative partnership between patients, healthcare providers, and regulatory agencies, promoting transparency, accountability, and ultimately, better patient outcomes. Through increased patient engagement and the utilization of patient-reported data, this approach enables healthcare systems to identify potential safety issues earlier, tailor treatment strategies to individual needs, and enhance overall drug safety surveillance efforts.
Similar to Dia feb 2010 final presentation webinar 2 mll (20)
This presentation was provided by Steph Pollock of The American Psychological Association’s Journals Program, and Damita Snow, of The American Society of Civil Engineers (ASCE), for the initial session of NISO's 2024 Training Series "DEIA in the Scholarly Landscape." Session One: 'Setting Expectations: a DEIA Primer,' was held June 6, 2024.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Normal Labour/ Stages of Labour/ Mechanism of LabourWasim Ak
Normal labor is also termed spontaneous labor, defined as the natural physiological process through which the fetus, placenta, and membranes are expelled from the uterus through the birth canal at term (37 to 42 weeks
How to Add Chatter in the odoo 17 ERP ModuleCeline George
In Odoo, the chatter is like a chat tool that helps you work together on records. You can leave notes and track things, making it easier to talk with your team and partners. Inside chatter, all communication history, activity, and changes will be displayed.
This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
Thinking of getting a dog? Be aware that breeds like Pit Bulls, Rottweilers, and German Shepherds can be loyal and dangerous. Proper training and socialization are crucial to preventing aggressive behaviors. Ensure safety by understanding their needs and always supervising interactions. Stay safe, and enjoy your furry friends!
Strategies for Effective Upskilling is a presentation by Chinwendu Peace in a Your Skill Boost Masterclass organisation by the Excellence Foundation for South Sudan on 08th and 09th June 2024 from 1 PM to 3 PM on each day.
Executive Directors Chat Leveraging AI for Diversity, Equity, and InclusionTechSoup
Let’s explore the intersection of technology and equity in the final session of our DEI series. Discover how AI tools, like ChatGPT, can be used to support and enhance your nonprofit's DEI initiatives. Participants will gain insights into practical AI applications and get tips for leveraging technology to advance their DEI goals.
Exploiting Artificial Intelligence for Empowering Researchers and Faculty, In...Dr. Vinod Kumar Kanvaria
Exploiting Artificial Intelligence for Empowering Researchers and Faculty,
International FDP on Fundamentals of Research in Social Sciences
at Integral University, Lucknow, 06.06.2024
By Dr. Vinod Kumar Kanvaria
A workshop hosted by the South African Journal of Science aimed at postgraduate students and early career researchers with little or no experience in writing and publishing journal articles.
MATATAG CURRICULUM: ASSESSING THE READINESS OF ELEM. PUBLIC SCHOOL TEACHERS I...NelTorrente
In this research, it concludes that while the readiness of teachers in Caloocan City to implement the MATATAG Curriculum is generally positive, targeted efforts in professional development, resource distribution, support networks, and comprehensive preparation can address the existing gaps and ensure successful curriculum implementation.
MATATAG CURRICULUM: ASSESSING THE READINESS OF ELEM. PUBLIC SCHOOL TEACHERS I...
Dia feb 2010 final presentation webinar 2 mll
1. Expanding Clinical Research Beyond Borders: The Importance of Latin America Dr. Marlene Llopiz Venn Life Sciences Mexico
2. Growing markets Introduce Latin America (LATAM) Describe what Latin America has to offer What is available in LATAM? What about quality? What about timelines? Assess the possibility of conducting global trials in LA Analyze the overall challenges for Latin American countries Aims and Objectives 2 www.diahome.org Drug Information Association
16. In recent years, several regions around the world have provided new frontiers for conducting phase I-IV clinical trials. Latin America has come into the limelight for pharmaceutical studies. Introduction: The Importance of LA 5
43. Careful selection is made of each Latin American country to participate in global trials dependent on the shortness and complexity or lack thereof of complications for study conduction and of course, patients, sites and investigator availability. Country Selection Drug Information Association www.diahome.org 11
44. Principal investigators and sites are adequately selected meeting and complying with protocol and study needs and requirements with the necessary experience. Site and PI Selection Drug Information Association www.diahome.org 12
45. Non-disclosure agreements signed Reception of protocols (or synopsis) and request for proposal from clients (at a local or corporate level) are received Protocols (or protocol synopsis) are reviewed Therapeutic indication is carefully analyzed (incidence and prevalence of the disease in each country) Proposals with budgets are submitted dependent on country, sites, patients, complexity of trial, etc. Steps to be Taken for Clinical Trials in LA Drug Information Association www.diahome.org 13
46. Confidentiality agreements are signed with investigators and site facilities that are pre-selected dependent on client indication Feasibility studies are conducted or recommended sites and investigators reviewed (based on protocol purpose, therapeutic indication, patient recruitment, etc.) Once sites are selected, all documents are translated into Spanish (and Portuguese for Brazil). Powers of Attorney must be obtained for the CRO to manage the trial. Steps to be Taken for Clinical Trials in LA Drug Information Association www.diahome.org 14
47. A description letter of the study is submitted to the Ethics Committee (EC) together with: the protocol, informed consent form, investigator´s brochure, patient diaries and CRF´s (Documents submitted in the language of submission (Spanish) in addition to English) Each site will have a fee that must be paid. Steps to be Taken Drug Information Association www.diahome.org 15
48. Once approval from EC is obtained and a letter of authorization is obtained, Ministry of Health (MoH) submission must be officially made submitting all study and site documents in English and Spanish. In certain countries, after approval from a local EC is obtained, then documents must be submitted to a national EC Once MoH approval is obtained, an import license must be solicited providing the manufacturer´s and supplier´s name and address and a description of the product and quantity. At each institution, a fee will have to be paid for each procedure. Steps to be Taken Drug Information Association www.diahome.org 16
49. Certified warehouses are contracted for study supply receipt and distribution to sites. In sum, regulatory submission and approvals vary per country. Regulatory Timelines Drug Information Association www.diahome.org 17
50. Drug Information Association www.diahome.org 18 Regulatory TimelinesLATAM Country Comparison Drug Information Association www.diahome.org 18
51. Recommended Label Requirements In Spanish Protocol reference number/title Contents Administration route Lot/reference number Expiration date Storage conditions For Investigational Use Only Keep out of reach of children Manufacturer or Sponsor´s name and address. Drug Information Association www.diahome.org 19
52. Import License – after protocol approval Timeline: 2-3 weeks Rule 4.3: to import samples from an approved protocol (non-controlled drugs and lab kits). Exportation: rule 4.3 also allows to export human tissue or serum samples. Import/Export Process Drug Information Association www.diahome.org 20
53. Serious Adverse Reactions (SARs): 7 days after site´s notification plus 8 days to complete the information. Non-serious adverse reactions to be reported at the end of the study. Safety letters should be sent every 6 months for phase IV studies. For Phase I-III trials, the reports are sent at the end of the study. Pharmacovigilance Standard (NOM-220-SSA1-2002) Official Communications from CNFV Safety Report Drug Information Association www.diahome.org 21
54. Clinical Trial Approval in Mexico Drug Information Association www.diahome.org 22 Clinical Trial Approval in Mexico Final Protocol (Spanish) Investigator’s Drug Brochure (Spanish) Informed Consent Form (Spanish) Power of Attorney Details on importation of CTM, labs 4-8 weeks IRB/EC SSA / Secretaria de Salud (MOH) 4 – 6 weeks Clinical Trial Approval Letter 2 – 3 weeks Import License Study Start
59. Disease patterns that reflect both the West and the developing world Opportunities for time efficiencies with seasonal disease trials Region primarily uses just two languages: Portuguese (Brazil) and Spanish Quality of data comparable to that of data collected in North America Growing pharmaceutical market Advantages of Conducting Trials in Latin America Drug Information Association www.diahome.org 25
60. One of their main concerns is the timely fashion and quality of regulatory strategies to follow and comply with related to their studies to bring new drugs to market in these parts of the world. Timelines Drug Information Association www.diahome.org 26
61. Timely submissions and project start-ups are often difficult tasks due to the complexity of the necessary documentation required and delays in their delivery in each Latin American country versus differences with other continents. Timelines Drug Information Association www.diahome.org 27
62.
63. a reduction in costs with strategic multi-centered studies, and
64. credible and objective results for submission to higher regulatory authorities for marketing approvals.
65. International trial results could have significant medical importance and may have an impact on future products. Advantages to Studies in LATAM Drug Information Association www.diahome.org 28
66. The fact that a given study is approved by FDA / EMEA does not necessarily mean that it will be approved by local MoHs throughout Latin America. Avoid as much as possible the need to clarify or submit extra documents to the Ethics Committees and/or MoH after submitting the protocol for review. This significantly delays protocol approval. Submit all documents together. Do not submit in bits and pieces. Submit the protocol with as many amendments as possible. Final Considerations Drug Information Association www.diahome.org 29
67. Dr. Marlene Llópiz Regional Director for Latin America Venn Life Sciences Clinical Research +52 55 9171- 0288 +52 1 55 3335 - 2952 (Mexico City) marlene.llopiz@vlsworldwide.com marlene.llopiz@post.harvard.edu Contact Information Drug Information Association www.diahome.org 30
