Program Duration: Approx. 28 Weeks Start. cosmetics, natural product, nutraceutical and other life-science industries. Pharmaceutical Regulatory Affairs professionals responsible for developing, compiling, and filing documentation required to support the licensing and approval of pharmaceutical drugs. They. TIPT was established in 1992 and registered in Canada by the Ministry of Training, Colleges & Universities of Ontario. The TIPT Difference. What Sets TIPT Apart? Dedicated Focus on. Pharmaceutical Regulatory Affairs and Quality Operations (Co-op) Program Code: RAQC: Campus: Seneca@York: Duration: 2 semesters (1 Year) Offered: Summer Fall Winter. The first semester will provide you with the fundamentals required in both regulatory affairs and quality operations. Quality Operations. With your one-year graduate certificate, you'll be prepared for a dynamic career as a regulatory affairs associate, regulatory affairs assistant, quality assurance associate, quality. The pharma regulatory affairs are important for the knowledge of the laws and regulations mandated by the federal government. Pharmaceutical Regulatory Affairs(Integrated Co- Op)Credential Awarded: Ontario Post- Graduate Diploma ( Dip. Pharm RA)Program Duration: Approx. Weeks Start Dates: January 2. April 1. 8, July 1. October 1. 7Schedule: Mon – Thu: 9: 0. Fri: 9: 0. 0am – 2: 0. Your Career Option. In this program, you will learn and acquire specialized knowledge and practical skills required to function as a Pharmaceutical Regulatory Affairs professional in the pharmaceutical, biotechnology, medical devices, food, cosmetics, natural product, nutraceutical and other life- science industries. Pharmaceutical Regulatory Affairs professionals responsible for developing, compiling, and filing documentation required to support the licensing and approval of pharmaceutical drugs. They are involved in active liaison with regulatory authorities such as the Canadian Therapeutic Products Directorate (TPD) and the US Food and Drugs Administration (FDA). The success of the Company is invariably dependent on the accuracy and efficiency of drug submissions Graduates of this program enjoy a high percentage employment rate and work for both multinational and generic company employers such as GSK, Apotex, Biovail, Teva, Patheon, Novopharm, Astra. Welcome to TOPRA - The Organisation for Professionals in Regulatory Affairs. Training Programs. Classroom Training. Drug Regulatory Affairs. PG Diploma in Drug Regulatory Affairs [API & Formulation] PG Diploma in Drug Regulatory Affairs [API] PG Diploma in Drug Regulatory Affairs [Formulation]. Regulatory Affairs being the backbone of every pharma industry, it is very important to understand the current regulations and guidelines and IPM helped me achieve this knowledge through the 6 months Drug RA course. The Regulatory Affairs Certificate Program combines RAPS’ renowned expertise with industry-leading training to expand your regulatory knowledge and strengthen your organization. Testimonials. Here's what people are saying about GIRA regulatory training. 'GIRA's training institute offers highy quality courses. it gave me a much needed broader perspective and a multi- faceted view of regulatory affairs. Zeneca, Pharmascience, Amgen, and Taro pharmaceuticals. They also find employment in biopharmaceutical, biotechnology and advanced- drug delivery companies. Our Program. The program entails an intensive series of learning modules developed to enable a practical understanding of the regulatory approval and communication processes involving pharmaceutical and biotechnology drugs as well as natural health products and medical devices. While the primary emphasis is on regulatory affairs as it applies in North America under the Canadian Health Products and Food Branch (HPFB) and the US Food and Drugs Administration (FDA), the regulations in other major jurisdictions such as Europe, Japan and Australia will also be covered. You will acquire knowledge of international health care system, health care legislation, procedures and practices for regulating the development, manufacture, quality assurance and marketing of health care products. Practical Experience (Integrated Co- op)A unique and highly successful aspect of our program is our hands- on approach provides the opportunity for students to apply and integrate their knowledge in a "real- world" work setting under TIPT's IPE system. You will receive practical experience with actual submissions that have been approved by regulatory authorities. Throughout the program, various practical projects expose the student to pharmaceutical industry submissions and lets students apply their skills and knowledge in a real- world work setting. Admission 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. Internationally- educated individuals must have the equivalent of a Canadian Bachelor of Science degree. Degrees completed outside of Canada must be evaluated by one of the following - International Credential Assessment Service, University of Toronto Comparative Education Service or World Education Service. Meeting the minimum requirements does not guarantee admission to the program. Regulatory affairs personnel are the first-line assurance that company products and documentation are in accordance with regulatory bodies worldwide. Pharmaceutical Regulatory Affairs Training and Professional Designation Programs. Online Training Programs Include: 90 days of 24/7 access to individual eLearning courses and 180 days for eLearning Professional Designation Programs. The Regulatory Affairs Certificate: Pharmaceuticals provides a cost-effective, convenient option that will equip you or your organizational team with the tools and knowledge needed to progress as a regulatory professional and stay ahead of the competition.
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