Module 1: Introduction to Regulatory Affairs and Global Clinical Trial Governance

• Overview of regulatory affairs and clinical research ecosystem

• Regulatory frameworks: ICH, WHO, FDA, EMA, and national agencies

• Key terminologies and roles in the regulatory process

• Hands-on Exercise: Mapping global regulatory authorities and responsibilities

Module 2: Principles of Good Clinical Practice (GCP)

• Historical background and ethical foundations (Nuremberg Code, Declaration of Helsinki)

• ICH-GCP guidelines and core responsibilities of stakeholders

• Quality assurance, data integrity, and patient protection

• Hands-on Exercise: Evaluating GCP compliance in a case study scenario

Module 3: Clinical Trial Applications and Regulatory Submissions

• Clinical trial authorization and registration procedures

• Investigational New Drug (IND) and Clinical Trial Application (CTA) processes

• Electronic Common Technical Document (eCTD) submissions

• Hands-on Exercise: Drafting a simplified regulatory submission dossier

Module 4: Ethical Oversight and Institutional Review Boards (IRBs)

• Structure, role, and responsibilities of Ethics Committees

• Informed consent process and patient rights protection

• Protocol review and monitoring of clinical trial conduct

• Hands-on Exercise: Conducting an ethics committee protocol review simulation

Module 5: Clinical Trial Documentation and Data Management

• Essential documents in clinical research and GCP recordkeeping

• Investigator’s Brochure (IB), Case Report Forms (CRFs), and Trial Master Files (TMFs)

• Data verification and quality assurance processes

• Hands-on Exercise: Reviewing a sample TMF for GCP compliance gaps

Module 6: Regulatory Inspections and Audit Readiness

• Preparing for inspections and audits by regulatory authorities

• Common non-compliance findings and corrective actions

• Managing responses and continuous improvement plans

• Hands-on Exercise: Creating a mock audit response plan

Module 7: Product Registration and Marketing Authorization

• New Drug Application (NDA) and Marketing Authorization Application (MAA) processes

• Labeling, packaging, and pharmacovigilance integration

• Global harmonization and mutual recognition procedures

• Hands-on Exercise: Simulating a product registration workflow

Module 8: Post-Marketing Surveillance and Regulatory Compliance

• Post-market safety monitoring and risk management

• Periodic Safety Update Reports (PSURs) and pharmacovigilance linkage

• Regulatory reporting timelines and documentation best practices

• Hands-on Exercise: Compiling a mini post-marketing safety compliance checklist

Module 9: Emerging Trends and Digital Tools in Regulatory Affairs

• Role of AI, eCTD, and blockchain in regulatory processes

• Data transparency and e-submission systems

• Future trends in regulatory harmonization and digital transformation

• Hands-on Exercise: Exploring a regulatory submission management software demo

Module 10: Capstone Project – Integrating GCP and Regulatory Compliance

• Applying GCP principles across all phases of clinical research

• Developing an integrated regulatory compliance framework

• Group presentation and discussion on real-world case analysis

• Hands-on Exercise: Developing a full compliance improvement plan for a clinical site