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Course Description

This program is designed to provide the foundational knowledge and approach / coordination for integrating the patient perspective into the full medicines lifecycle, including regulatory decision making and post-marketing efforts, which can improve patient outcomes and increase the success of the product.

Who is the target audience?

It is designed for professionals involved in Patient Advocacy, Patient Engagement, Patient Experience and Access

What am I going to get from this course?

  1. Describe the investigational product development process
  2. Review Regulatory Authorities (FDA, EMEA, MOHs, etc.) regulations and the ICH GCP E6 Guideline for Good Clinical Practices (GCP)
  3. Describe the roles and responsibilities of the Clinical Research Coordinator (CRC) before, during and after a clinical trial
  4. Identify the requirements of the Investigator (PI, CoI / Sub-I) in supervising clinical research
  5. Discuss the role of an Institutional Review Board (IRB) / Independent Ethics Committee (IEC), its composition and responsibilities in the clinical trial process
  6. Define the informed consent process and the elements of the informed consent document
  7. Define source documents and Case Report Forms (CRFs) in relation to CRF completion and Source Document / Data Verification (SDV)
  8. Describe definitions related to safety management, identification of adverse events and reporting requirements