CR017 Introduction to Pharmacovigilance Activities and Pharmacoepidemiological Studies

CR017 Introduction to Pharmacovigilance Activities and Pharmacoepidemiological Studies

Pharmacovigilance is a critical aspect of ensuring the safety and efficacy of medications used by patients. This course provides an introduction to pharmacovigilance activities, the regulatory framework for pharmacovigilance, and the principles of pharmacoepidemiologic studies. Students will gain a comprehensive understanding of the essential elements of pharmacovigilance, including the importance of collecting, analyzing, and reporting adverse drug events (ADEs) to regulatory authorities. The course will also cover the essential components of pharmacoepidemiology, such as study design, data sources, and analysis methods.

Upon completion of this course, students will have a broad understanding of pharmacovigilance activities and pharmacoepidemiologic studies, including the regulatory framework and the methods used to assess drug safety and effectiveness. Students will be able to apply their knowledge to evaluate the risks and benefits of medications, to design and conduct pharmacovigilance studies, and to communicate findings.

Key Learning Points:
  • Overview of drug development; historical and legal basis for pharmacoepidemiology and pharmacovigilance
  • Application of principles of pharmacology to pharmacoepidemiology
  • Regulation and pharmacoepidemiology; premarketing pharmacoepidemiology; conflicts of interest
  • Data sources in pharmacoepidemiology
  • Study designs considerations; introduction to bias and confounding in pharmacoepidemiology
  • Design and implementation of therapeutic risk management policies; risk evaluation and mitigation strategies (REMS)
  • Assessment of therapeutic risk management
  • Distributed data network systems; signal detection in passive and active surveillance data systems
  • Drug utilization research; medication errors
  • Emerging topics; future directions

Registration Fee: $945+HST (CAD)

CR017 Introduction to Pharmacovigilance Activities and Pharmacoepidemiological Studies

Our exclusive
happy student saying.

A Transformative Journey

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

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

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

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

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

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

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

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

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

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

Saeeda Hasan

Clinical Research Graduate