Post-Approval and Marketing Activities is a comprehensive course that covers the essential aspects of pharmacovigilance, safety reporting regulations, and requirements for post-approval drug and medical device marketing activities. The course is designed for regulatory affairs professionals and other stakeholders involved in post-approval activities.
The course begins with an overview of pharmacovigilance, including the principles, guidelines, and regulatory requirements for monitoring and reporting adverse drug reactions (ADRs). Participants will learn about the role of pharmacovigilance in ensuring patient safety and how to comply with regulatory requirements for safety reporting.
Next, the course will cover post-NOC changes, including safety and efficacy updates, supplements, and level III changes. Participants will learn about the regulatory requirements for making these changes and the documentation required for submission to regulatory agencies.
The course will also cover the Drug Master File (DMF), which is a critical component of post-approval drug marketing activities. Participants will learn about the contents of a DMF, its importance in regulatory compliance, and the process for submitting and maintaining a DMF.
The course will also include an overview of Annual Notification requirements for post-approval drug marketing activities. Participants will learn about the timelines and regulatory requirements for submitting annual notifications to regulatory agencies.
Medical devices post-marketing activities will also be covered in the course, including timelines, fee structures, and reference back to MDSAP and act/regulations guidance documents. Participants will learn about the regulatory requirements for post-approval medical device marketing activities, including license amendments and the documentation required for submission.
Learning Points:
By the end of the course, participants will have a comprehensive understanding of post-approval and marketing activities for drugs and medical devices, including pharmacovigilance, safety reporting regulations, and requirements, post-NOC changes, DMF, annual notification, and license amendments. Participants will gain practical skills and knowledge that they can apply to their work in regulatory affairs.
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
