This course provides a comprehensive overview of the regulatory requirements for generic drugs including the development, submission process, and approval of generic drugs. Throughout the course, students will gain a practical understanding of the regulatory landscape for generic drugs, including the roles of Health Canada, the Patented Medicine Prices Review Board (PMPRB), the Canadian Agency for Drugs and Technologies in Health (CADTH), US-FDA and European regulators.
The process of developing a generic drug, including the requirements for formulation development, stability testing, and analytical testing as well as the importance of the regulatory strategy in the development process will be discussed in details.
Students will learn about the concept of bioequivalence, which is a critical requirement for the approval of generic drugs. They will understand how to conduct bioequivalence studies and how to interpret the results. Students will also gain an understanding of biosimilars, which are becoming increasingly important in the generic drug market. They will learn about the regulatory requirements for the approval of biosimilars, including the need for comparative clinical studies.
Additionally, students will learn about the submission process for generic drugs, including the requirements for an Abbreviated New Drug Submission (ANDS) and the importance of providing comprehensive supporting data. They will also understand the review process and how to respond to requests for additional information.
Learning Points
Overall, this course provides students with a thorough understanding of the regulatory requirements for generic drugs globally, enabling them to navigate the complex regulatory landscape and effectively manage the development and approval of generic drugs.
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
