Postgraduate Certificate and Mini Master Degree in Regulatory Affairs of Drugs and Medical Devices RADEX Institute

This program is designed to assist the student with obtaining the necessary skills and knowledge to effectively navigate and manage regulatory affairs (RA) processes including operational RA, strategic RA, clinical RA, CMC RA, and submission specialist RA.

The program includes critical thinking workshops and a project to allow students the opportunity to apply the theoretical knowledge in a practical way.

Features

• Cover all fields of regulatory affairs comprising operational RA, strategic RA, clinical RA, CMC RA, Submission Specialist RA, and regulatory compliance.
• Critical thinking workshops that allow the trainees to apply theoretical knowledge in a practical way.
• A hands-on project that exposes the trainees to real-life experience.

Objective

The objective of our Regulatory Affairs of Drugs and Medical Devices Graduate Certificate is to prepare students to apply their learned knowledge about USFDA and European regulations and regulatory affairs processes related to drugs, biologics, biosimilars, medical devices, combination products, and cosmetics to bring a medical product to market.

Being licensed by the Commission for Independent Education, Florida Department of Education and consisting of administration and faculty team members who have many years of practical experience in the integrated regulatory affairs in the pharmaceutical, medical devices, dietary supplement and cosmetics field makes RADEX Institute the best place to earn the needed knowledge in the Regulatory Affairs field.

Post Graduate Support

At RADEX institute we offer our graduates the best post-graduation support programs out there.

·We at RADEX answer all questions our graduates confront in their regulatory affairs career. If our graduates need our help, we have the expertise to guide and support them.

·Rapid response times ensure support and questions of our graduates will be answered around the clock by our expert faculty.

Career Center

·RADEX team skills our graduates resume and prepare them for job interviews.

·We at RADEX help our graduates to cover all of the Regulatory Affairs requirements to be better prepared for their next interview

Placement Services

RADEX Institute, through their experienced team, offer our graduates full support to help them get the job they want!

RADEX Mini Master’s Degree is designed to graduate highly qualified professionals to manage global regulatory processes for companies innovating and developing cutting-edge submitting products.

General Information

•The first in Florida Board of Education licenses RADEX Institute and all our programs.

• RADEX is the first institute in the State of Florida that offers a 100% online LIVE, interactive, weekend-long, comprehensive, and all-inclusive Regulatory Affairs Post graduate program as a Mini master’s degree.

RADEX Mini Master’s Degree is designed to graduate highly qualified professionals to manage global regulatory processes for companies innovating and developing cutting-edge technology processes in the pharma industries.

• RADEX Mini Master’s Degree / USA & Europe program will prepare students to apply their learned knowledge about USFDA and European regulations and regulatory affairs processes related to drugs, biologics, biosimilars, medical devices, combination products, and cosmetics to bring a medical product to market.

Training Program Information (USA & Europe)

• Duration: 9 months (32 Weeks) accelerated 6 months (24weeks)

• 14 Credit Hours

• Tuition Fees: $ 5,879

• Online live lectures every Saturday and Sunday

• Upon graduation Students will be experienced to become competent professionals in regulatory affairs processes, regulations, and submissions in the USA and Europe.

Introduction

• This professional program will provide integrated knowledge and broad perspectives about all the regulations and regulatory processes for drugs, biologics, biosimilars, medical devices, combination products, and cosmetics to prepare the RA trainees to effectively manage the regulatory activities.

• From discovery to commercialization, this professional program will cover the steps that are required to bring a medical product to market.

• Strengthen the understanding of regulatory strategies and review processes of the medical products' submissions by the regulatory authorities.

• Graduate professionals who are able to communicate effectively in an industry environment composed of scientists, and business professionals.

• Contribute productively to an interdisciplinary team tackling complex problems.

General Objectives

• Cover the steps from discovery to commercialization to bring drugs, biologics, biosimilars, medical devices, combination products, and cosmetics to the market.

• Intensive clarification of all the current regulations of the USA and Europe including Saudi Arabia, UAE, and Jordan.

• Prepare trainees to effectively manage the regulatory process with practical application for the importation, development, or commercialization of drugs, biologics, biosimilars, medical devices, combination products, or cosmetics.

• Covering all the regulatory affairs fields comprising operational RA, strategic RA, clinical RA, CMC RA, Submission Specialist RA, and regulatory compliance.

• Critical thinking workshops that allow the trainees to apply the theoretical knowledge practically.

• Hands-on project that exposes the trainees to real-life experience.

General Outlines

• Drug Life Cycle.

• Clinical Trials and Good Clinical Practice (GCP).

• Quality Assurance (QA) and Quality Control (QC) Regulatory Concepts.

• Good Manufacturing Practice (GMP).

• Europe and USA Drug Regulations and Regulatory Submissions.

• Europe and USA Biologic Regulations and Regulatory Submissions.

• Europe and USA Medical Device Regulations and Regulatory Submissions.

• Europe and USA Cosmetic Regulations and Regulatory Submissions.

• Europe and USA Combination Products Regulations and Regulatory Submissions.

• Advertising and Promotion Regulatory Framework.

• Europe and USA Pharmacovigilance Regulations and Regulatory Submissions.

Syllabus (USA & Europe)

Course Name Training Hours / Week Duration Credit

Course 1: GCP, GMP, QA, and QC, 3 Hours Lecture 2 months

International Perspective (USA & 3 Credit

3 Hours Weekly Critical (9 weeks)

Europe)

Thinking Project

Course 2: Drug, Biologic, and Biosimilar 3 Hours Lecture 2 months

Regulatory Process, International 3 Credit

3 Hours Weekly Critical (7 Weeks)

Perspective (USA & Europe)

Thinking Project

Course 3: Medical Device Regulatory 3 Hours Lecture 2 months

Process, International Perspective (USA 3 Credit

3 Hours Weekly Critical (8 Weeks)

& Europe)

Thinking Project

Course 4: Cosmetics, Combination 3 Hours Lecture

Products, & Pharmacovigilance, 2 months 3 Credit

International Perspective (USA & 3 Hours Weekly Critical (8 Weeks)

Europe) Thinking Project

Practical Project Take home Self Project 1 month 2 Credit

(4 weeks)

Total Credit 14 Credit