This course is designed to provide students with an overview of the regulatory requirements and processes involved in the development, approval, and post-marketing surveillance of pharmaceutical products. The course will cover the legal and ethical framework of drug regulation, including the role of regulatory authorities, such as Health Canada, the Food and Drug Administration (FDA) in the United States, and the European Medicines Agency (EMA) in Europe.
Students will learn about the key elements of the regulatory approval process and address the post-marketing surveillance of pharmaceutical products. Students will gain an understanding of the importance of regulatory compliance, quality assurance, and the impact of regulatory affairs on the pharmaceutical industry.
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.
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
