Navigating Regulatory Affairs: Ensuring Compliance in Clinical Research

Aim

Short Courses Objectives

Short Courses Structure

Week 1: Introduction to Regulatory Affairs in Clinical Research

• Overview of regulatory affairs and its importance in clinical research
• Roles and responsibilities of regulatory affairs professionals

Week 2: Regulatory Authorities and Guidelines

• Understanding global regulatory authorities and their roles
• Familiarization with key regulatory guidelines and requirements

Week 3: Investigational New Drug (IND) Application

• Components and preparation of an IND application
• Interaction with regulatory agencies for IND submission and review

Week 4: Investigational Medicinal Product Dossier (IMPD)

• Structure and content of an IMPD
• Submission and evaluation of IMPD for clinical trials in Europe

Week 5: Ethics Committee Submissions

• Preparation of documents for ethics committee submissions
• Review process and ethical considerations in clinical research

Week 6: Informed Consent and Subject Protection

• Informed consent process and documentation
• Ensuring subject safety and rights in clinical trials

Week 7: Clinical Trial Authorization (CTA) Applications

• Preparation and submission of CTA applications
• Interaction with regulatory authorities for CTA approval

Week 8: Clinical Trial Protocol Amendments and Notifications

• Handling protocol amendments and substantial protocol deviations
• Notifications to regulatory authorities and ethics committees

Week 9: Post-Approval Regulatory Activities

• Pharmacovigilance and adverse event reporting
• Annual reports, safety updates, and periodic safety reports

Week 10: Good Clinical Practice (GCP) and Regulatory Compliance

• Overview of GCP guidelines and their relationship to regulatory compliance
• Quality management systems and audit readiness

Week 11: Regulatory Inspections and Audits

• Preparation for regulatory inspections and audits
• Response strategies and corrective actions

Week 12: Regulatory Submissions and Post-Trial Activities

• Submission of final study reports and closeout documents
• Archiving, record retention, and regulatory compliance after trial completion

Who Should Enrol?

Short Courses Outcomes