Certificate Course in ICH-GCP [Good Clinical Practice]

ICH-GCP, E6 (R2+R3), Good Clinical Practice, IRB/IEC, Investigator, Sponsor

Ratings: 2.98 / 5.00




Description

Title: Certificate Course in ICH-GCP [Good Clinical Practice]

Master the Principles of Ethical Clinical Research.

Are you looking to establish a strong foundation in clinical research ethics and compliance?

Enroll in our comprehensive "Certificate Course in ICH-GCP [Good Clinical Practice]" to gain an in-depth understanding of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) guidelines.


Key Highlights:

  1. Essential ICH-GCP Principles: Dive into the core principles of ICH-GCP, including the protection of human subjects, data integrity, and the ethical conduct of clinical trials. Understand the requirements for conducting clinical research that is accepted globally.

  2. Roles and Responsibilities of IRB/IEC: Gain insights on Roles and Responsibilities of IRB/IEC, their Composition, Functions and Operations, Procedures, Records, Submission and Communication.

  3. Roles and Responsibilities of Investigator: Understand Roles and Responsibilities of an Investigator, Protocol compliance, Premature suspension of trial, Medical care, Safety Reporting, Informed consent & End of Participation, Investigational product management, Randomization & Unblinding.

  4. Roles and Responsibilities of Sponsor: Understand Roles and Responsibilities of a Sponsor, Communication with IRB/IEC and Sponsor oversight, Quality management, Non-compliance, safety assessment & reporting, Investigational products, Data/ Records and Clinical study report.

  5. Investigator's Brochure: Development of the Investigator’s Brochure, Reference Safety Information and Risk-Benefit Assessment, General considerations and Contents of the Investigator’s Brochure.

  6. Clinical Trial Protocol and its Amendment: Clinical trial protocol and Content of Clinical trial protocol.

  7. Essential Records for the conduct of Clinical Trial: Management of Essential Records, Essential Records for All Trials and Potential Essential Records.

Why Choose This Course?

  • Industry-Recognized Certification: Earn a certificate that is recognized by the industry, showcasing your expertise in ICH-GCP to potential employers and sponsors.

  • Career Advancement: Enhance your career prospects in clinical research. Gain the knowledge and skills required to excel in roles related to clinical trial management, monitoring, and regulatory affairs.

  • Global Opportunities: ICH-GCP is an internationally recognized standard. Equip yourself with skills that are in demand worldwide, opening doors to global career opportunities.

Who Should Enroll:

  • Clinical Research Associates (CRAs)

  • Clinical Trial Coordinators

  • Investigators

  • Regulatory Affairs Professionals

  • Anyone interested in Ethical clinical research

Don't miss this opportunity to gain a comprehensive understanding of ICH-GCP and enhance your career in clinical research. Enroll now and take the first step toward becoming a proficient clinical research professional!

Note: No prior knowledge of clinical research is required. Basic understanding of medical terminology is recommended.


What You Will Learn!

  • Fundamentals of ICH-GCP
  • Principles of ICH-GCP
  • Roles & Responsibilities of IRB/IEC
  • Roles & Responsibilities of Investigator
  • Roles & Responsibilities of Sponsor
  • Investigator's Brochure (IB)
  • Clinical Trial Protocol and its Amendment
  • Essential Records for the conduct of Clinical Trial

Who Should Attend!

  • Clinical Research Associates (CRAs)
  • Clinical Trial Coordinators
  • Investigators
  • Regulatory Affairs Professionals
  • Pharmacy, Medical and Life science students
  • Anyone interested in Ethical clinical research