Navigating Regulatory Affairs: Ensuring Compliance in Clinical Research
Clinical trial regulations, Good Clinical Practice (GCP), Adverse event reporting and pharmacovigilance, Investigational new drug (IND) application, Clinical trial design
About Program:
Aim: This program aims to provide participants with a comprehensive understanding of regulatory affairs in clinical research. Participants will learn the regulatory requirements, guidelines, and processes involved in conducting clinical trials, ensuring compliance, and safeguarding the rights and well-being of research subjects.
Program Objectives:
- Understand the regulatory landscape governing clinical research, including international, regional, and local regulations.
- Learn the regulatory requirements for study initiation, conduct, monitoring, and closeout.
- Gain insights into the ethical considerations and regulatory submissions involved in clinical research.
- Understand the roles and responsibilities of regulatory authorities, sponsors, investigators, and ethics committees.
- Acquire knowledge of the documentation and reporting requirements in clinical research, including adverse event reporting and safety monitoring.
What you will learn?
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
Intended For :
Post Graduates, Research Scholars, Academicians, Industry Professionals of Pharmaceutical, Biotechnology, and Medical Device Companies, Graduates
Career Supporting Skills
Program Outcomes
- Comprehensive understanding of regulatory affairs in clinical research.
- Knowledge of international, regional, and local regulations governing clinical trials.
- Competence in ensuring compliance with regulatory requirements throughout the clinical trial process.
- Understanding of ethical considerations and regulatory submissions in clinical research.
- Proficiency in documentation and reporting requirements for clinical trials.
