Master Class in Good Clinical Practices and Good Pharmacovigilance Practices

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Full program in the downloadable agenda.

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PROGRAM

Day 1

26th October

Welcome and overview of program
Clinical Trial Specificities/Regulations
Clinical Trials – Specificities/Regulations - Latin America
Clinical Research Activities

Day 2

27th October

Clinical Trial Conduct - Investigator’s responsibilities and GCP
Clinical Trial Conduct - Sponsor responsibilities and GCP
Clinical Trial Conduct - Informed Consent
Clinical Trial Conduct - Institutional Review Boards / Ethics Committees
Clinical Trial Conduct - Confidentiality and Privacy
Clinical Trial Conduct - Participants Safety and Adverse Events
Clinical Trial Conduct - Quality Assurance
Clinical Trial Conduct - The research protocol
Clinical Trial Conduct - Investigator’s Brochure
Clinical Trial Conduct - Documentation and Record Keeping
Clinical Trial Conduct - Research Misconduct
Clinical Trial Conduct - Roles and Responsibilities
Clinical Trial Conduct - Patient Recruitment and Retention
Clinical Trial Conduct - Safety Management
Clinical Trial Conduct - Investigational New Drug Product Management
Clinical Trial Conduct - Audits, Inspections and Monitoring of clinical studies

Day 3

28th October

Overview of Pharmacovigilance system
Post – Marketing Safety Reporting
Risk Management Plans