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The Impact of Final ICH GCP E6 R2 Guideline on Budgeting and Contracts in Globalization Environment: Changes Affecting Sponsors, CROs, Clinical Investigators, Sites

4631
Duration : 60 Minutes

Marina Malikova, Executive Director, Boston University School of Medic

Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics an Read more


In this revised ICH GCP guideline on budgeting and contracts for clinical trial webinar will discuss the impact of changes in ICH GCP E6 R2 on investigator, site, sponsors CROs roles and responsibilities and the impact of clinical trial conducts and organizational practices along with evaluate solutions/applicability/modifications of organizational SOPs, processes, procedures and staff training; and discuss opportunities for implementing the revised guideline.

Course Objectives:

Managing clinical trials, of any size and complexity, requires strategic planning and efficient execution. As scientific advances continue, the types of therapies being developed have higher potency and novel targets; and increased pressure to have study designs that speed up clinical development. In 2016, the ICH revised the E6 guidelines entitled “Integrated Addendum To ICH E6(R1): Guideline For Good Clinical Practice E6(R2).” to further standardize processes in biomedical products development, decrease redundancies; and reflect the current research landscape such as increases in globalization, study complexity, and technological capabilities.

In this webinar we will identify the changes impacting investigators, sites, Sponsors, CROs: responsibilities and roles and explain the impact of the revisions on clinical trials conduct and organizational practices. Also, during this webinar we will evaluate solutions/applicability/modifications of organizational SOPs, processes, procedures and staff training; and discuss opportunities for implementing the revised guideline.

Course Outline:

The revised guidelines The updated ICH GCP E6 R2 is more descriptive than the previous version and describes 26 items of change. This session will explore the changes to provide a better understanding of how they impact conduct of clinical trials and provide solutions for implementation.

• GCP E6 R2 Guideline explanation
          o New items in definitions
          o New sections on investigator responsibilities, including oversight
          o New sponsor section on quality management, including risk assessment
          o Monitoring plans defined and implemented
          o Serious breaches
• Globalization
• The new section on computer validation and electronic records
• Risk-based Quality Management (RBQM)
• SOPs development and implementation
          o Systematic approach in assessing organizational SOPs
          o Approach on processes and practices
          o Designing modifications to assist with implementation
• Standardization

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Directors of Clinical Operations
• Medical Affairs specialists and leaders of this division
• Project Managers
• Staff from Pharmaceutical/Device Companies or CROs involved with the management of clinical trials
• Project Team Leaders
• Regulatory Affairs
• QC/QA Specialists
• Research and Department
• Clinical Research Coordinators (CRCs)
• Clinical Research Associates
• Data Managers
• Biomedical product development
• Grant Administrators

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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Subject : The Impact of Final ICH GCP E6 R2 Guideline on Budgeting and Contracts in Globalization Environment: Changes Affecting Sponsors, CROs, Clinical Investigators, Sites


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