CCCEP Number: 1684-2023-3609-I-Z
This course is accredited for pharmacists in Canada as per the CCCEP requirements and has been accredited by the CCCEP for 7 CEUs. The Canadian Council on Continuing Education in Pharmacy (CCCEP) is a national organization established to accredit continuing pharmacy education programs intended to be delivered to pharmacy. CCCEP accreditation is recognized by the pharmacy regulatory authorities in all provinces and territories of Canada.
This activity is designed to orient students to the Drug Development Process, clinical research process, and how clinical safety and pharmacovigilance functions within the corporate and regulatory context from Canadian and international perspectives. The activity also provides a comprehensive introduction to the clinical research process and its history and evolution. Development of drugs is used as a model. Students will learn about the responsibilities of the principal investigator, the sponsor, and the patient, in addition to the responsibilities of the review ethics board. Upon completion, participants will be able to prepare an organizational chart depicting a typical research team, defining the roles or responsibilities of each member. The participant should also be able to describe the product approval process and discuss the general conduct of a typical clinical trial.
Taking a new pharmaceutical product from the laboratory to the market requires years of bench research, and nonclinical research to assess the safety profile of the new drug. The most important element of the early discovery process is to select the best new molecular entities to enter clinical trials and to limit failure in full development. The next phase is careful clinical research on human subjects to assess the safety and efficacy of your product, constant interactions with drug agencies, manufacturing your product in the most efficient manner compliant with the appropriate regulations.
This course is designed to introduce the students to the main steps of the drug development process, from drug discovery, and preclinical animal testing to all phases of clinical research and post-approval drug safety surveillance from the US and international regulatory perspectives.
Learning Points:
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
