Evaluación de Ensayos Clínicos
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2023-09-22 09:00:00
2023-09-22 18:00:00
Evaluación de Ensayos Clínicos
Evaluación de Ensayos Clínicos
Fecha: 22 de Septiembre 2023
Teatro Calderón de la Barca - Campus Santiago Gangotena
El CEISH-USFQ, considera que el Seminario sobre Ensayos clínico a desarrollarse el 22 de septiembre de 2023, servirá como un instrumento de capacitación para este tipo de evaluaciones con temas que incluyen la Normativa nacional e internacional, la validez científica de Ensayos Clínicos, evaluación ética, metodológica, jurídica y su relevancia.
REGISTRO
Contamos con su prestigiosa presencia en el evento, el mismo que será gratuito y abierto al público interesado, con un cupo limitado.
Puedes realizar tu registro para el evento en el siguiente link:
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Teatro Calderón de la Barca - Campus Santiago Gangotena
USFQ
no-reply@usfq.edu.ec
America/Guayaquil
public
Place
Calderón de la Barca Theater - Santiago Gangotena Campus
Clinical Trial Evaluation
Date: September 22, 2023
Calderón de la Barca Theater - Santiago Gangotena Campus
REGISTRATION
We have the honor of having your prestigious presence at the event, which will be free of charge and open to the interested public, with limited capacity.
You can register for the event at the following link:
Información
- The Ethics Committee for Research Involving Human Subjects of the University San Francisco de Quito USFQ, known as "CEISH-USFQ," is an organ responsible for the ethical evaluation of research involving human subjects. The CEISH-USFQ has received approval from the Ministry of Public Health of Ecuador, granted by Official Letter No. MSP-VGVS-2020-0274-O dated May 25, 2020, and by the Office for Human Research Protections (OHRP) of the United States Department of Health & Human Services, with IORG0003353, IRB# 00003994.
- The evaluation of research protocols is governed by the "Substitutive Regulation of the Regulation for the Approval and Monitoring of Ethics Committees for Research Involving Human Subjects (CEISH) and Ethics Committees for Healthcare (CEAS)," issued through Ministerial Agreement No. 00005 of 2022.
- Among the protocols that CEISH-USFQ can evaluate and is qualified to do so are Clinical Trials involving drugs, vaccines, medical devices, surgical innovation, biological products, or processed natural products for medicinal use, subject to health registration. This type of evaluation is governed by the Regulation for the Approval, Development, Surveillance, and Control of Clinical Trials, No. 0075-2017.
- Due to the complexity surrounding this type of evaluation and to facilitate the approval of protocols in this category for interested parties, CEISH-USFQ, committed to advancing this type of research in the country, promotes a series of training sessions and regular updates.
- The CEISH-USFQ believes that the Seminar on Clinical Trials to be held on September 22, 2023, will serve as a training tool for these types of evaluations, covering topics including national and international regulations, the scientific validity of Clinical Trials, ethical, methodological, legal assessment, and their significance.
- As invited panelists, we will have nationally and internationally renowned experts such as Dr. Carla Sáenz from the OPS, Esp. Hipatia Criollo Figueroa from the MSP, Narcisa Isabel Martillo Huacondel from ARSCA, and Dr. Ximena Garzón, former Minister of Health and current member of CEISH-USFQ.
- We look forward to your prestigious presence at the event, which will be free of charge and open to the interested public, with limited seating.
Schedule
Seminar
TIME | TOPIC | SPEAKER |
---|---|---|
09:00 AM – 09:15 AM | Welcome | President of CEISH-USFQ, Dr. Gulnara Borja PhD. |
09:15 AM – 10:00 AM | Introduction to Clinical Trials | ARCSA Representative |
10:00 AM – 10:15 AM | Break | |
10:15 AM – 12:00 PM | National and International Regulations | MSP Representative |
12:00 PM – 02:00 PM | Lunch | |
02:00 PM – 04:00 PM | Scientific Validity of Clinical Trials (VIRTUAL) | Carla Sáenz PhD, OPS Representative |
04:00 PM – 04:15 PM | Break | |
04:15 PM – 05:30 PM | Ethical, Methodological, and Legal Evaluation of Clinical Trials | MSP Representative |
05:30 PM – 06:00 PM | Significance of Clinical Trials | CEISH-USFQ Representative, Dr. Ximena Garzón PhD |