Long Courses

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

MODE
Virtual (Google Meet)
TYPE
Self Paced
LEVEL
Moderate
DURATION
3 Months
VIDEO LENGTH
1

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

Batches

Spring
Summer

Autumn
Winter

Certificate

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