Regulatory Affairs

The Regulatory Affairs program at Viast is designed to prepare students for critical roles in ensuring that pharmaceutical and medical products comply with regulations and standards set by governmental agencies. This 3-year program offers an in-depth understanding of the regulatory environment, including submission processes, quality assurance, and compliance. The curriculum covers the essentials of regulatory guidelines, documentation, and ethical considerations. Through internships and practical training, students will gain the hands-on experience needed to excel in the regulatory field.

Duration: 3 years

Eligibility: 10+2 with Science stream

Career Prospects: Regulatory Affairs Specialist, Compliance Officer, Quality Assurance Manager, Regulatory Consultant, Clinical Trials Auditor.

Course Structure:

Introduction to Regulatory Affairs:

•    Overview of the regulatory environment
•    History and evolution of regulatory affairs
•    Roles and responsibilities of regulatory professionals

Regulatory Guidelines and Compliance:

•    Good Manufacturing Practices (GMP)
•    Good Clinical Practices (GCP)
•    Good Laboratory Practices (GLP)

Submission Processes and Documentation:

•    Preparing regulatory submissions (IND, NDA, ANDA)
•    Dossier compilation and electronic submissions
•    Regulatory documentation and record-keeping

Quality Assurance and Control:

•    Principles of quality assurance and control
•    Risk management and mitigation strategies
•    Conducting internal and external audits

Pharmacovigilance and Safety Reporting:

•    Adverse event reporting and management
•    Risk-benefit analysis
•    Post-marketing surveillance and safety monitoring

Ethical and Legal Considerations:

•    Ethical issues in regulatory affairs
•    Intellectual property rights and patent laws
•    Global regulatory requirements and harmonization (FDA, EMA, ICH)

Practical Training and Industry Exposure:

•    Internships with pharmaceutical companies, regulatory agencies, and CROs
•    Hands-on training with regulatory software and tools
•    Case studies and real-world compliance projects

Capstone Project:

•    Independent research project in regulatory affairs
•    Collaboration with industry mentors and academic advisors
•    Presentation and defense of research findings