This course on Regulatory Affairs (RA) for Natural Health Products (NHPs) will cover the essential aspects of the regulatory process for NHPs, including timelines and Quality Assurance (QA) requirements.
The course will start by introducing the regulatory landscape for NHPs in various regions, such as Canada and the US, and will cover the differences between the regulatory frameworks, and the agencies responsible for regulating NHPs in each region.
Next, the course will focus on the various stages of the regulatory process, starting from product development and pre-market assessment, to post-market monitoring and compliance. It will cover the requirements for clinical trials, safety and efficacy testing, and data submission.
The timelines for each stage of the regulatory process will also be discussed, as are the factors that can impact the timeline. The course will also highlight the importance of proper documentation and record-keeping to meet regulatory requirements.
In addition, the course will cover the QA requirements for NHPs, including Good Manufacturing Practices (GMPs), product labeling, and advertising guidelines. It will also discuss the importance of conducting audits and quality checks to ensure compliance with regulations and to maintain product safety and efficacy.
Learning Points:
Throughout the course, case studies and examples will be used to illustrate key concepts and provide practical insights. By the end of the course, participants will have a comprehensive understanding of the regulatory process for NHPs, including the timelines and QA requirements, and will be equipped to navigate the regulatory landscape with confidence.
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
