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

Show Your Interest

Explore

MODE
Virtual (Google Meet)

TYPE
Self Paced

LEVEL
Moderate

DURATION
3 Months

VIDEO LENGTH
1

About

–

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.

Show Your Interest Explore

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!

List of Currencies