This course provides an in-depth understanding of the regulatory requirements and processes for pharmaceutical products involved in the submission, labeling, and approval of pharmaceutical products. The course will cover the regulatory review and market authorization (MA) process, with a focus on Canada and the United States.
Students will learn about the key players and decision-makers involved in the regulatory review and MA process in Canada, including Health Canada, the Canadian Agency for Drugs and Technologies in Health (CADTH). The course will also examine the US MA process and the healthcare setup for MA, including the role of the FDA and other stakeholders.
In addition, the course will address the Common Technical Document (CTD) and New Drug Submission (NDS) submission process, including the requirements and guidelines for submission. Students will gain an understanding of the importance of product labeling and the regulatory requirements for Product Monographs (PM) and other regulatory documents.
Learning Points:
This course is ideal for students interested in pursuing a career in pharmaceutical regulatory affairs, drug development, or related fields. The course is also relevant for professionals working in the pharmaceutical industry who want to expand their knowledge of regulatory affairs and compliance and have an applied understanding of the regulatory submission process.
The instructors are industry-experienced in a supportive learning environment. Field-related internships give students real-world experience. Students also receive ongoing job search assistance and career services from AAPS.
Sedigheh Fadaye Vatan
Pharmaceutical Quality Assurance and Regulatory Affairs Graduate
Taking the AAPS Cannabis Management, Quality & Laboratory course was the one of the best decisions for my career. They are all extremely knowledgeable in their field, with real life experiences to share.
Orenda Von Gernet
Cannabis – Management, Quality and Laboratory Graduate
I enrolled in the QA/QC program and midway through the program I successfully landed a 6-month internship at Teva Pharmaceuticals. Upon completing my program part-time, I got a full-time position with PerkinElmer.
Lukman Nahle
Pharmaceutical Quality Assurance and Quality Control Graduate
I am very happy that I chose AAPS as my next academic endeavor after graduating University. The course was very useful in teaching me the things that I will need to know when entering the Cannabis industry.
Zachary Petkov
Cannabis – Management, Quality and Laboratory Graduate
Coming to AAPS to pursue my PG Diploma in CRDSP has been one of the best career decisions. I’ve received my offer letter to join as Project Management Associate at Axiom real-time metrics solutions, On.
Remya Pushparajan Subha
Clinical Research Graduate
The food safety and quality program at AAPS provided me with the knowledge required for the Canadian food industry. As a newcomer to Canada, I really appreciated the welcoming vibe the college offered.
Dania Hariri
Food, Technology, Safety and Quality Graduate
I was newcomer in Canada from Nepal. I enrolled in PG Diploma in Pharmaceutical QC/QA/RA course which i think was the best. After 3 weeks of hard work into co-op days, I was offered a full-time job.
Yushma Shakya
Pharmaceutical Quality Assurance and Quality Control Graduate
I am excited to share my employment news. I am now working as Quality Assurance Manager and I couldn’t have done it without your help and encouragement. I want to specifically thank all the AAPS instructors.
Abolfazl Darashti
Food, Technology, Safety and Quality Graduate
Thank you to everyone at AAPS for helping me in my postgraduate training. I am now really excited to be working at the McKesson Corporation (Fortune Top 500 Company) as a Health Services Case Manager.
Amjad Atrash
Clinical Research Graduate
I am happy to share that I have received a job as a Clinical Research Recruiter at BioPharma Services Inc. It was a hard and persistent job but I couldn’t have done it without the AAPS support.
Saeeda Hasan
Clinical Research Graduate
