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
Virtual (Google Meet)
Self Paced
Moderate
3 Months
1
About
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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.
Short Courses 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.
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
Participant’s Eligibility
Post Graduates, Research Scholars, Academicians, Industry Professionals of Pharmaceutical, Biotechnology, and Medical Device Companies, Graduates
Short Courses 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.
Fee Structure
We are excited to announce that we now accept payments in over 20 global currencies, in addition to USD. Check out our list to see if your preferred currency is supported. Enjoy the convenience and flexibility of paying in your local currency!
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Recent Feedbacks In Other Workshops
good presentation, more time is needed to elaborate on some issues
The course was well communicated and interactive
lecture delivered well but the title of workshop was a little misleading
