Certification in Advanced Regulatory Affairs
Excellence in Regulatory Affairs Training
“With the most up-to-date regulatory guidelines and an innovative learning approach, we equip our students with the skills needed for a successful career in Regulatory Affairs.”
The Certification in Advanced Regulatory Affairs course at Shaan Research Center (SRC) provides candidates with a comprehensive understanding of the legal, scientific, and business aspects necessary to navigate the regulatory environment effectively. Students will learn how products are developed, approved, and marketed while adhering to legal frameworks and regulatory guidelines.
What We Teach in Pharmacovigilance Training
Drug Safety Terminology
Learn the essential terms and concepts in Pharmacovigilance, enabling professionals to effectively identify, report, and prevent adverse drug reactions.Regulatory Guidelines
Gain a thorough understanding of global regulatory frameworks, including guidelines from the International Council for Harmonisation (ICH), the World Health Organization (WHO), and the Central Drugs Standard Control Organization (CDSCO).US and EU Perspectives
Explore the Pharmacovigilance regulatory requirements specific to the United States and the European Union. This module provides a global perspective on drug safety practices.
The curriculum is tailored to equip students with the skills and knowledge necessary to excel in the fast-growing field of Pharmacovigilance, ensuring compliance with global standards and best practices.
Learning Objectives
Understand the importance of safety monitoring in Pharmacovigilance.
Gain a comprehensive overview of global Pharmacovigilance regulations.
Learn about the regulatory laws governing Pharmacovigilance worldwide.
Master the ICH Efficacy Guidelines for drug safety.
Understand the contributions of the CIOMS Working Group to Pharmacovigilance.
Gain knowledge of regulatory requirements from the FDA, EMA, and the National Pharmacovigilance Program in India.
Develop the skills for screening and searching regulatory websites for safety reports and updates.
Learn how to manage labeling changes and prepare a Company Core Data Sheet (CCDS).
FAQs
Who is eligible for the Advanced Regulatory Affairs Course?
This course is ideal for anyone interested in the regulatory domain of Pharmacovigilance, including fresh graduates and experienced professionals. It is especially suited for life science graduates seeking to transition into regulatory affairs.What is the duration of the course?
The Advanced Regulatory Affairs Course runs for one month and includes 20 sessions, each lasting one hour.What are the prerequisites for this course?
Candidates should have a basic understanding of clinical trials. A brief introduction to Pharmacovigilance will also be provided. We recommend completing a Certification in Pharmacovigilance & Basics of Regulatory Affairs as a foundation before enrolling in this course.Why Choose SRC?
At SRC, we offer a curriculum designed to meet the needs of the healthcare industry. Our expert trainers, real-world projects, and placement assistance ensure you are well-equipped to start your career in regulatory affairs. The course includes personalized career counseling and resume preparation to help you stand out to potential employers.
