CRA – Monitoring and Coordinating Clinical TrialsCourse # 76
Evening Course

Conducted by: Ms. Adi Davidi, Ms. Techiya Toaff, Ms. Vered Levy, Adv. Bilhat Azar
SKU: 19066D
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Join the future technologies of the medical world. The accelerated development rate of drugs, biological products and medical devices leads to a steep increase in the number and magnitude of the clinical trials conducted around the world and in Israel. Developers, manufacturers and health authorities need information to enable the marketing of safe and efficient medicinal products. The clinical trial...Continue reading

Join the future technologies of the medical world. The accelerated development rate of drugs, biological products and medical devices leads to a steep increase in the number and magnitude of the clinical trials conducted around the world and in Israel. Developers, manufacturers and health authorities need information to enable the marketing of safe and efficient medicinal products.
The clinical trial is an essential and central stage in the development route, safety and the quality proof of medicinal and biological products and medical devices. Its objective is to professionally collect essential information regarding the safety and the efficacy of the investigated product.
Israel has the ideal terms to become a leading center for clinical trials, performed by dedicated, professional and experienced investigators, physicians and scientists.
The management of the entire clinical trial process, from the selection of medical centers and investigators to closure of sites and documents, including watching the GCP requirements and the local rules and regulations regarding the volunteer /patient’s rights are the responsibility of a Clinical Research Associate – the “Monitor”.
This course provides the basic knowledge in clinical trial management and qualifies the students to become a Clinical Research Associates – CRA. The course opens a new, dynamic and challenging channel for a fascinating and full satisfaction work, with specific promotion possibilities in a scientific – medical professional environment

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Dates: 
  • 12/11/2019
  • 14/11/2019
  • 19/11/2019
  • 21/11/2019
  • 26/11/2019
  • 28/11/2019
  • 03/12/2019
  • 05/12/2019
  • 10/12/2019
  • 12/12/2019
  • 17/12/2019
  • 19/12/2019
  • 31/12/2019
  • 02/01/2020
Course location: Engineering School building, 30 Haim Levanon St., Tel Aviv
Duration: 14 meetings, Half-Day (Evening)
Hours: 17:00 - 20:30
Credits:
Course Language: עברית

Course price: Free of charge
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Issues to be covered

  • Introduction: concepts, terms, definitions
  • Regulatory Requirements
  • The Israeli Ministry of Health
  • The USA, European Community and other Countries
  • GCP – Good Clinical Practice: the basic guidelines and rules for conducting a clinical trial around the world
  • IRB – International Review Board: Ethical Committees, Helsinki Committees
  • The Sponsor, The Investigator
  • Monitoring of clinical trials – management of the trial’s protocol and visits for identification and selection of investigators and study sites; site visits for trial initiation, monitoring visits, closure visits.
  • Informed Consent, Flow of Information
  • Essential Documentations: Trial’s protocol, Amendments, medical records, study data, investigator’s brochure, reports and queries
  • Pharmacy, Drug Control
  • The rule of the Laboratory in clinical trials
  • The Coordinator
  • Risk Management
  • Electronic Records and Signatures, Validation of Software
  • Medical Introductions: Basic Concepts and Updated Information in various Clinical trials fields in different medical professions

Prior Education Requirements:

  • Graduate of Life or Nature Sciences, Medicine, Pharmacy, nursing or equivalent fields
  • English literate

The Graduate Diploma
will be given to graduates of the course who will complete the following tasks:Grade 70% and up in the final exams
Grade “Pass” in the course’s Project
Participation of 80% and up in classes

Who should attend

Physicians, Professionals from the Life and Nature Sciences, Pharmacists and nursing professionals who are interested in knowing the field of clinical trials and / or looking for a change in their career and becoming CRAs.

Benefits to the Participants

  • Understanding terms and concepts of the clinical trials field
  • Acquaintance with the regulatory requirements, and ‘in depth’ knowledge of the international requirements of the GCP – Good Clinical Practice
  • Acquiring a wide overview of monitoring clinical trials
  • Acquiring tools for management of the different stages of the trial
  • Acquiring a new, interesting and required profession in a dynamic, developing field with promotion opportunities and a well financial honorarium

About The Lecturer

Adi Davidi
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Techiya Toaff
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Vered Levy
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Bilhat Azar
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