Regulatory Affairs Pharma and Medical Devices

PREREQUISITE:

To take this course, we highly recommend that candidates must possess the following requirements:

• A Bachelor of Science degree, majoring in general science, Biological, Applied or Health Science, Chemistry, Pharmacy, some areas in Life Sciences or a related field. A GPA average of C+ is recommended. 

COURSE OVERVIEW:

With the ever-changing laws and regulations, there is a greater drive for regulatory affairs professionals who can help companies effectively bring medical products to market. MITS will help you be prepared to make you become an effective asset to your company by leading an exceeding regulatory activity management.

Our rigorous training program is designed to sharpen your understanding of current regulations and their practical application in the development and commercialization of drugs, biologics, and medical device products. Regulatory affairs courses introduced within this program will provide you with the incorporated knowledge and comprehensive perspectives you need to effectively manage the regulatory process. From discovery to commercialization, this regulatory affairs training program will encompass detailed steps that are required to introduce and deliver a medical product to market – in the US or around the globe.

This program provides participants with a good foundation in understanding the fundamental areas of regulatory affairs and quality operations within various industries, including pharmaceutical. Participants are well-groomed for career prospects involving drug or medical device submissions and quality assurance functions and roles.

COURSE OBJECTIVES:

By completing this program, participants will be able to develop several proactive skills applicable to their careers, such as:

• Obtain the essential knowledge and skills required to help organizations operate an increasingly intricate regulatory environment
• Obtain a good working foundation of the necessary knowledge and skills to work within a variety of fields, such as medical product development, pharmaceutical sales, strategic marketing, and clinical investigations
• Evaluate every phase of the drug development and regulation process
• Hone an individual’s understanding of the laws that encompasses the development, manufacturing, and commercial distribution of drugs, biologics, and medical devices
• Evaluate and interpret the effect of the emerging developments and trends in the reshaping of several medical device regulations

COURSE CURRICULUM:

By having a solid knowledge on the many regulatory requirements related to medical device and pharmaceuticals, professionals will be able to thoroughly understand the complex processes and their impacts to clinical trials, approvals, and market strategy. With this understanding, coupled with a more effective manner in communicating with other professionals, may help organizations avoid problems before they occur.

This program offers a comprehensive curriculum, demonstrating important regulatory requirements and concepts using case study discussions of products from different clinical specialties. All medical device pathways to market are discussed in a detailed and efficient manner, concentrating on the advantages and challenges of each. Examples are given by employing real-work situations and are presented in an interactive format.

• Regulatory aspects of drug development
• Marketing authorization
• Overview on the FDA Regulations
• Pharmacovigilance
• Clinical trial directives and application procedures
• Health economics and outcomes research
• Helvetization of regulatory documents
• Special regulations in Biologics
• Special regulations in Generics
• Special regulations in Biosimilars
• Special regulations in Orphan Drugs
• Special regulations in Pediatrics
• Special regulations in GMOs and advanced therapeutics including gene therapy
• Special regulations in Companion diagnostics
• Variations and change control
• Electronic submission

WHO NEEDS TO TAKE THIS COURSE:

MITS offers this training course for those who need a better understanding of the regulatory requirements related to medical device development.  It is also designed for those individuals working on the pharmaceutical or biotechnology field and now working on medical devices as well as those handling on combination products.

Scientists, engineers and technicians working on device design and development, product and product development managers, business development managers, marketing managers, quality assurance or quality control personnel, regulatory affairs professionals, investment and acquisition specialists, and field service engineers will all take an advantage from this program.

CAREER OUTLOOK:

The pharmaceutical and medicine manufacturing industry continues to experience increasing growth in both jobs and profits. They are relied upon to get new drugs and devices tested, approved, and distributed on the market. And as such, regulatory affairs specialists are continually in demand.

While employment prospects are bright across the field, regulatory affairs professionals with the most enriched education and practice skills are more likely to take advantage on the most opportunities and highest pay.