biomedical 4
Program

Navigating Regulatory Affairs: Ensuring Compliance in Clinical Research

“Ensuring Compliance in Clinical Research: Navigating Regulatory Affairs with Confidence”

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

Fee Plan

INR 1999 /- OR USD 50
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Intended For : Graduates, Post Graduates, Research Scholars, Academicians, Industry Professionals of Pharmaceutical, Biotechnology, and Medical Device Companies

Career Supporting Skills

Regulatory Submissions and Documentation Handling Inspections and Audits Post-Approval and Post-Trial Regulatory Activities Informed Consent and Subject Protection

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.