Regulatory Affairs in Clinical Research
Mentor Based
Duration
3 Months
Eligibility
Mode
Online
Course Aim
This course aims to provide participants with comprehensive knowledge and skills in regulatory affairs within the context of clinical research. It aims to enable participants to navigate complex regulatory frameworks, ensuring compliance and efficient regulatory submissions. The course aims to prepare participants for regulatory affairs roles in the clinical research industry.
Course Objectives
The primary objective of this course is to provide participants with comprehensive knowledge and skills in regulatory affairs within the context of clinical research. Participants will learn to navigate complex regulatory frameworks, ensuring compliance and efficient regulatory submissions.
Program Structure
Module 1: Introduction to Regulatory Affairs in Clinical Research
• Overview of regulatory affairs in clinical research
• Regulatory agencies and their roles
• Historical context and evolution of regulations
Module 2: FDA and International Regulatory Framework
• Understanding the FDA’s role and regulations
• International regulatory harmonization
• Clinical research regulations worldwide
Module 3: Regulatory Submissions and Documentation
• Preparing regulatory submissions (INDs, NDAs, etc.)
• Regulatory document preparation and management
• Electronic Common Technical Document (eCTD) format
Module 4: Compliance and Auditing
• Ensuring regulatory compliance throughout trials
• Conducting regulatory audits and inspections
• Corrective and preventive actions (CAPAs)
Module 5: Regulatory Strategy and Planning
• Developing effective regulatory strategies
• Regulatory considerations for study design
• Engaging with regulatory agencies
Module 6: Post-Market Surveillance and Reporting
• Post-market surveillance requirements
• Adverse event reporting
• Safety and efficacy monitoring post-approval
Module 7: Emerging Regulatory Trends
• Current and future regulatory trends
• Regulatory considerations for innovative therapies
• Real-world evidence and regulatory acceptance
Module 8: Case Studies and Practical Applications
• Analyzing real-world regulatory cases
• Applying regulatory knowledge to practical scenarios
• Regulatory affairs in action
What You Will Get?
Program work is completed through online system under the guidance of program coordinator.
e-LMS for smarter Learning
24 x 7 open chat box
Excellent option for summer project
Online live lectures from the experts
Prepare real time projects
Certificate on project completion
Various Job Opportunities
Steps For Enrollment
Step 1: Click On The Below Mentioned Link “Apply Here”
Step 2: Fill All Basic Details Of Yours (Name, Email Id, Contact Details, Image)
Step 3: Choose Your Program, Session And Duration Of Program
Step 4: Fill Payment Details In The Form And Submit
Step 5: Hurray! You Will Get Your Login Credential Within 48 Hrs.
Skills to Score
Fee Plan
Basic Course
3 Month Mentor Based Course
INR 12,999/- or USD 199
- Access to e-LMS
- Immediate commencement
- Study material at your doorstep
- Project Guidance from Subject Experts
- Paper Publication Opportunity
- Self Assessment
- Final Examination
- Printed certification
- Printed Marksheet
Advanced Course
6 Month Mentor Based Course
INR 22,999/- or USD 349
- Access to e-LMS
- Immediate commencement
- Study material at your doorstepv Complete Basic Course
- Complementary Scientific Technical Writing
- Real Time Project for Dissertation
- Project Guidance from Subject Experts
- Paper Publication Opportunity
- Self Assessment
- Final Examination
- Printed certification
- Printed Marksheet
Course Outcomes
• Upon completing this course, participants will be well-prepared to:
• Understand the complex regulatory landscape in clinical research.
• Navigate FDA regulations and international regulatory requirements.
• Prepare and manage regulatory submissions and documentation.
• Ensure compliance and effectively handle regulatory audits.
• Develop and implement effective regulatory strategies.
• Stay informed about emerging regulatory trends and their implications.
Join Now!
It’s time for you to be enhance your knowledge and be an edge above others. Register yourself and get started today.
