Course Directors & Scientific Committee
COURSE DIRECTORS
Inês Zimbarra Cabrita, Ph.D
Francisca Patuleia Figueiras, Ph.D
SCIENTIFIC COMMITTEE
Fausto J. Pinto, MD, Ph.D, FESC, FACC, FSCAI, FASE
Dulce Brito, MD, Ph.D, FESC
Joaquim Ferreira, MD, Ph.D
Catarina Sousa, MD
Cristina Valente, Pharm D.
Summary
DESCRIPTION: Running clinical studies is a complex task that requires many skills ranging from Good Clinical Practice knowledge of applicable regulations up to operational aspects on how to carry out clinical studies. Having a high trained and specialized study team conducting clinical research is the main key to achieve success in recruitment objectives and high standards of quality and performance.
Course Aims
With focus on the practical aspects of clinical studies, the course has the main objectives:
- Provide to the participants the tools and knowledge needed to successfully achieve quality and high performance in all steps of clinical research.
- Provide information on clinical research practical aspects, essential to achieve the highest quality data, ensuring the safety and well-being of study participants.
- Identify all the parties involved in a clinical trial and the main responsibilities associated with each of them (e.g. Sponsor, Principal Investigator, CRO, and Monitor).
- Understand the roles and responsibilities of the different parties involved in a clinical research, and the fundamentals of Good Clinical Practice (GCP).
- Understand the current legislation, National and European, and other standards of reference applicable to clinical research.
- Identify the responsible authorities for approving a clinical trial, their respective timelines for approval, and the documents required for submitting an application for a clinical trial authorization.
- Understand which the regulatory activities are after the clinical trial approval.
- Describe the different types of clinical research with emphasis on clinical trials and their phases.
- Understand the difference between Quality control vs. Quality assurance and Audits vs. Inspections.
Who Should Attend
The course is designed to: Research teams (Senior and Junior Researchers, from Senior Physicians to Intern doctors, Nurses, Biomedical Scientists, Allied Health Professionals, Study Coordinators) with or without experience in clinical research.
Course Structure & Program
DAY 1 – Interactive Sessions & Workshop (9am-5pm)
- Types of Studies and Research Design
- Regulatory Aspects
- Patient-Centered Research
- Clinical Study: the first contact with Investigators and study team
- Interactive Workshop
DAY 2 – Interactive Sessions & Workshop (9am -5pm)
- The Physician as Clinician and Principal Investigator
- Clinical Study Ongoing Activities & Stakeholders
- Audits and Inspections
- Pharmacovigilance
- Interactive Workshop
- Exclusively on the 4th Edition (11 and 12 October)The 4th edition of our 2-days course which will be held on 11th and 12th October 2018 will have a Special Guest speaker: Dr. Gaia Kiru from UKCRC registered Imperial Clinical Trials Unit (ICTU) at Imperial College London.
Dr. Kiru will be covering the topics “Audit and Inspections: be aware, be prepared!” as well as giving a special talk on “Managing a pan-European Trial: challenges and solutions”, detailing her experience of running research across Europe.
Course Methods
The course will focus on practical aspects of clinical research with examples and exercises to consolidate the knowledge acquired during the course.
The lectures will be in Portuguese with support material written in English.
INFORMATION FOR FULL ENGLISH VERSION:
The lectures will be in English, as well as, the support material will be providing written in English.
Certificate of Attendance
During approximately 14 hours (divided into two consecutive days), participants will acquire skills that will allow them to optimize their performance during the conduction of the clinical studies/trials.
At the end of the two training days, the participants will have a final exam (composed with multiple choice questions). In order to receive a Certificate of Attendance & Approval in this course, participants should be approved in the final exam (MCQ´s + practical exercises).
Why Should I Do This Course
This course will provide you with the necessary knowledge and tolls to achieve success in recruitment objectives, high standards of quality and performance in clinical research.
General Information & Registration
- i. Online Registration
- Here
- For the course will be admitted a minimum of 8 participants and a maximum of 16 participants in each session of the course. The participants will be admitted based on the registration order.
- ii. Fees
- 300€
The payment method will be the bank transfer using the following data:
Account Holder: AIDFM
IBAN: PT50001800003666547200180
BIC/SWIFT: TOTAPTPL
- 300€
- iii. Venue
- Associação para Investigação e Desenvolvimento da Faculdade de Medicina
Av. Prof. Egas Moniz, 1649-028 Lisboa
- Associação para Investigação e Desenvolvimento da Faculdade de Medicina
- iv. Contacts
- Email: training.cetera@medicina.ulisboa.pt
- Tel. +351 217 930 920
- Mob. +351 96 748 5630
Comments & Interviews From Past Participants
“This course is extremely helpful for every clinician who wishes to participate in clinical research. It allows you to understand all the complexities of clinical research, and definitely helped me improve.”
(Pedro Carrilho Ferreira, Cardiologist Consultant at Santa Maria University Hospital, CHLN, Lisbon, Portugal.(May 2017)
“This course has added a fundamental knowledge for the development of my professional activity. A great opportunity to learn more about clinical research”.
Susana Silva, MSc, Study Coordinator at Cardiovascular Research Support Department, CHLN, Lisbon
Portugal (May 2017)
Course Editions @Media
https://justnews.pt/noticias/projeto-inovador-da-apoio-a-investigacao-clinica-em-portugal
Scientific Endorsement
European Accreditation Council for Continuing Medical Education
The 4th Edition of this course has been granted 12 CME points from the European Accreditation UEMS-EACCME® which means that our Course has fulfilled the UEMS-EACCME® quality requirements. CME = Continuing Medical Education.
