Two letters of recommendation 6. English Language Proficiency Proof: Students for whom English is not their primary language must submit one of the following: This program is offered under the written consent of the Minister of Training, Colleges and Universities for the period from October 28, to October 27,
The expertise of a DRA professional may be used in areas such as clinical trials, manufacturing, compliance, patenting, sales and marketing, IT, finance and scientific writing. Collecting data and preparing submissions to regulatory agencies Assisting in the development of procedures to ensure regulatory compliance Interfacing with regulatory agencies Facilitating identification and resolution of scientific and regulatory issues with regulatory agencies Remaining current with federal and international regulations and communicating that information within the organization, including the creation of training materials Participating in the development of new products and services Participating in quality audits In addition to a strong background in pharmaceutical science and regulatory affairs, a successful DRA professional should have excellent interpersonal and communication skills, high ethical standards, attention to detail and strong organizational skills.
Program Mission The mission of the Master of Science program in Drug Regulatory Affairs is to prepare students to become lifelong learners and leaders in a variety of settings including biotechnology, medical devices, pharmaceuticals, consulting arena, and liaise with government and regulatory agencies worldwide.
These abilities will be acquired through specific coursework and seminars and other professional and personal development offered during the course of study. Program Goals and Objectives Goal 1: Demonstrate an understanding of the role of a medical products regulatory affairs specialist and the dynamic nature of the regulatory field.
Identify and utilize the laws and regulations that apply to the development, testing, and production of new medical products, including medical devices, In-Vitro Diagnostics IVDs, pharmaceuticals, biotechnology-derived therapeutics, and biologics. Identify a specific regulatory issue for either a drug or device and be able to justify an appropriate position or strategy through presentation and written skills that permits students to acquire analytic and reasoning skills along with effective communication skills.
This should include; identification of the issue, research of the topic, and development of a report summarizing the findings. This presentation should have relevant content and appropriate information that addresses the selected topic adequately.
Demonstrate the ability to develop personal and professional skills in the field of regulatory affairs. Based on such discussions develop a hypothetical career pathway for yourself in outline format.
Students taking the Thesis Option must complete 33 credits of course work of which 3 credits are in PHA Research Methodology, 6 credits are in PHA Research and Thesis, submit a satisfactory thesis proposal, submit a satisfactory written thesis, and successfully defend orally their written thesis.
The following courses are required for the Specialization in Drug Regulatory Affairs:Executive Order , Promoting Energy Independence and Economic Growth Executive Order , Enforcing the Regulatory Reform Agenda.
M, Regulatory Reform Officers and Regulatory .
The Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices program is designed to produce graduates who are highly qualified to manage the regulatory process for companies innovating and developing cutting edge products in science and medicine. Regulatory Affairs and Quality Assurance Graduate Program of Temple University School of Pharmacy Pursue an Online MS in Regulatory Affairs and Quality Assurance (RAQA).
The original and most comprehensive academic graduate program in RA and QA celebrating 50 years of excellence. 2 Regulatory Affairs and Quality Assurance, M.S. Applicants who earned a degree at a non-U.S. institution must submit an equivalency evaluation of their transcript(s) through a third-party provider.
Academic. To be eligible for admission, you must possess the following: A Bachelor of Science degree, majoring in health science, pharmacy, some area in life sciences or a related field. Chief Human CapitalOfficer.
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