Regulatory Affairs Post Baccalaureate Certificate

Program Overview

The Post Baccalaureate Certificate in Regulatory Affairs equips individuals with the knowledge and skills to manage the regulatory process for innovative products in science, biotechnology, pharmaceuticals, and medicine. The program covers vital areas such as regulatory affairs, clinical documentation, FDA regulations, and quality management. Graduates are prepared for careers as Regulatory Affairs Specialists, Clinical Research Associates, and Quality Assurance Managers in the pharmaceutical, biotechnology, and medical device industries.

Program Outline

Degree Overview:

Overview:

The Post Baccalaureate Certificate in Regulatory Affairs program equips individuals with the knowledge and skills to effectively manage the regulatory process for companies developing innovative products in science, biotechnology, pharmaceuticals, and medicine. The program provides comprehensive instruction in vital areas such as regulatory affairs, clinical documentation, human and animal subject protection, Food and Drug Administration (FDA) regulations, data management and analysis, good manufacturing practices, and quality management.

Objectives:

Upon completion of the program, graduates will be able to:

• Understand the regulatory landscape for medical products and devices
• Interpret and apply regulatory guidelines and standards
• Manage clinical trial data and ensure compliance with ethical and safety regulations
• Prepare and submit regulatory documentation, including Investigational New Drug (IND) and New Drug Application (NDA) filings
• Implement quality management systems and ensure adherence to Good Manufacturing Practices (GMP)
• Effectively communicate with regulatory agencies and stakeholders

Program Description:

The Post Baccalaureate Certificate in Regulatory Affairs program is designed to provide students with a solid foundation in regulatory affairs and prepare them for successful careers in the pharmaceutical, biotechnology, and medical device industries. The program's curriculum consists of a combination of core courses and elective courses that delve into various aspects of regulatory affairs.

• Core Courses:
• MHA 6000 - Health Systems & the Healthcare Economy
• MHA 6100 - Leading & Managing People in Healthcare
• MENG 6140 - Foundations of Professional and Technical Writing
• RGAF 6000 - Introduction to Regulatory Affairs
• RGAF 6100 - Biostatistics Applied to Research
• RGAF 6200 - Regulatory Drugs & Biologics
• RGAF 6230 - Regulatory Devices and Diagnostics
• RGAF 6250 - Regulatory Clinical Evidence
• RGAF 6300 - Compliance in Regulatory Affairs
• Elective Courses:
• RGAF 6500 - Internship

Outline:

Course Schedule:

The program can be completed in as little as one year of full-time study. The following is a sample course schedule:

• Fall Semester:
• RGAF 6000 - Introduction to Regulatory Affairs
• RGAF 6100 - Biostatistics Applied to Research
• MHA 6000 - Health Systems & the Healthcare Economy
• Spring Semester:
• RGAF 6200 - Regulatory Drugs & Biologics
• RGAF 6230 - Regulatory Devices and Diagnostics
• MHA 6100 - Leading & Managing People in Healthcare
• Summer Semester:
• RGAF 6250 - Regulatory Clinical Evidence
• RGAF 6300 - Compliance in Regulatory Affairs
• Elective course

Individual Modules with Module Descriptions:

The program content is divided into modules, covering the following key areas:

• Regulatory Affairs Foundations: This module provides an overview of the regulatory process and introduces fundamental concepts in regulatory affairs.
• Clinical Research: This module focuses on the regulatory aspects of clinical research, including clinical trial design, data management, and ethical considerations.
• Product Development: This module covers the regulatory requirements for product development, including preclinical studies, IND submissions, and clinical trials.
• Regulatory Submissions: This module provides guidance on preparing and submitting regulatory documentation, including INDs, NDAs, and other regulatory filings.
• Quality Management: This module emphasizes the importance of quality management in regulatory affairs, covering topics such as GMPs, quality control, and risk management.

Assessment:

Assessment Methods:

Student performance is assessed through various methods, including:

• Exams: Written exams test students' understanding of the course material and their ability to apply regulatory principles to real-world scenarios.
• Assignments: Assignments, such as case studies and research projects, allow students to demonstrate their knowledge and skills in a practical setting.
• Presentations: Students may be required to present their findings or lead discussions, fostering their communication and critical thinking abilities.
• Participation: Active participation in class discussions and group projects is considered in the assessment of student performance.

Assessment Criteria:

Students are evaluated based on their ability to:

• Demonstrate a comprehensive understanding of regulatory affairs principles and practices
• Apply regulatory knowledge to solve real-world problems
• Communicate effectively in written and oral formats
• Work effectively in a team environment
• Maintain a high level of professionalism and ethical conduct

Teaching:

Teaching Methods:

The program employs a variety of teaching methods to cater to diverse learning styles and maximize student engagement:

• Lectures: Traditional lectures are used to provide foundational knowledge and introduce key concepts.
• Case Studies: Real-world case studies are presented to allow students to apply regulatory principles to practical scenarios.
• Group Projects: Collaborative group projects foster teamwork and enhance problem-solving skills.
• Online Discussions: Asynchronous online discussions facilitate peer-to-peer learning and encourage critical thinking.
• Guest Speakers: Industry experts are invited to share their experiences and insights with students.

Faculty:

The program is taught by a team of experienced faculty members with expertise in regulatory affairs, clinical research, and quality management. They are dedicated to providing students with a high-quality learning experience.

Unique Approaches:

• Industry Partnerships: The program has established partnerships with leading pharmaceutical, biotechnology, and medical device companies, providing students with access to real-world experience through internships and networking opportunities.
• Regulatory Simulation: Students participate in regulatory simulations that provide a realistic experience in managing regulatory processes, decision-making, and stakeholder interactions.
• Capstone Project: The capstone project allows students to apply their knowledge and skills to a comprehensive project that demonstrates their ability to solve complex regulatory challenges.

Careers:

Potential Career Paths:

Graduates of the Post Baccalaureate Certificate in Regulatory Affairs program are well-prepared for a variety of careers in the regulatory affairs field, including:

• Regulatory Affairs Specialist
• Clinical Research Associate
• Quality Assurance Manager
• Compliance Officer
• Medical Device Regulatory Affairs Consultant

Career Opportunities:

Graduates of the program are in high demand in the following industries:

• Pharmaceutical Industry
• Biotechnology Industry
• Medical Device Industry
• Healthcare Consulting
• Contract Research Organizations (CROs)

Career Outcomes:

Graduates of the program have gone on to successful careers in regulatory affairs, holding positions in leading pharmaceutical and biotechnology companies, regulatory consultancies, and government agencies.