This course on Regulatory Affairs (RA) for Biologics and Biotechnology Products will provide an in-depth understanding of the regulatory framework and drug approval process for biologics. It will cover the development, manufacturing, and regulatory requirements for biologics, including drug delivery considerations, safety, Quality Control (QC), and Chemistry, Manufacturing, and Controls (CMC) requirements.
The course will start with an introduction to the science behind biologics and biotechnology products, including their development and production. Participants will learn about the various types of biologics, such as monoclonal antibodies, recombinant proteins, vaccines, and gene therapy products. They will also gain an understanding of the unique challenges and considerations that arise in the development of biologics, such as variability, heterogeneity, and immunogenicity.
Next, the course will focus on drug delivery considerations for biologics and the challenges that come with each method. Participants will also learn about the various drug delivery devices and the importance of ensuring their safety and efficacy.
The course will then cover the safety and QC requirements for biologics, including the need for extensive preclinical and clinical studies to establish safety and efficacy. Participants will also learn about the importance of post-market monitoring and pharmacovigilance to ensure ongoing product safety.
Finally, the course will cover the regulatory framework for biologics, including the different regulatory agencies responsible for overseeing biologics in various regions, such as Health Canada, the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA). Participants will also gain an understanding of the drug approval process for biologics, including the various stages of regulatory review and the requirements for CMC data submission.
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 requirements for biologics and biotechnology products, including drug delivery considerations, safety, QC and CMC requirements, and the drug approval 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
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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
