ICH GCP Guidelines E6 Revision, R2 Addendum – Changes Impacting Sponsors-CRO-Sites

  • Product Id : FDB2832
  • Category : ,
  • Presenter :
  • Scheduled On : January 15 2019 1:00 pm
  • Duration : 60 Minutes

The revised guidelines are entitled “Integrated Addendum To ICH E6(R1): Guideline For Good Clinical Practice E6(R2).” The ICH steering committee comprised of representatives from the pharmaceutical industry and the regulatory bodies of the United States, Japan, the European Union (EU), Canada, and Switzerland.

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.

Areas Covered in the Session :

  • GCP E6 R2 Guideline
  • Globalization
  • Risk-based Quality Management (RBQM)
  • SOPs development and implementation, Standardization
Who Should Attend:

  • Directors of Clinical Operations
  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Medical Affairs Specialists and Leaders of this Division
  • Project Managers
  • Grant Administrators

FDB2832

Marina Malikova

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 and Interventional Radiology.

Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.

In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.

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