CR023 Drug Lifecycle Safety Management and Pharmacovigilance Compliance

CR023 Drug Lifecycle Safety Management and Pharmacovigilance Compliance

The course is designed to provide a comprehensive understanding of the entire drug development process, including post-market surveillance, safety management, and regulatory compliance. The course will cover the various stages of drug development, from preclinical trials to post-market surveillance and safety management.

Students will learn about the importance of pharmacovigilance in ensuring the safety of drugs and managing adverse events. This includes understanding the regulatory framework and guidelines for pharmacovigilance compliance, as well as the processes involved in identifying and reporting adverse events.

The course will also cover the various stakeholders involved in pharmacovigilance, such as regulatory agencies, pharmaceutical companies, healthcare professionals, and patients. Students will learn about the roles and responsibilities of these stakeholders in ensuring drug safety and compliance with regulatory requirements.

Other topics that will be covered in the course include risk management plans, signal detection, risk-benefit analysis, and drug safety communication. Students will also learn about the importance of data management and analysis in pharmacovigilance and drug safety.

Upon completion of the course, students will have a comprehensive understanding of drug lifecycle safety management and pharmacovigilance compliance, and will be able to apply this knowledge to real-world situations in the pharmaceutical industry.

Key Learning Points:
  • Drug product lifecycle: pharmacovigilance focus
  • Drug safety reporting processes in clinical trials
  • Post-marketing adverse event reporting: sources, processes, and requirements
  • Expedited reporting requirements
  • Regulatory requirements for pharmacovigilance throughout stages of drug product lifecycle
  • Adverse drug reaction report

Registration Fee: $995+HST (CAD)

CR023 Drug Lifecycle Safety Management and Pharmacovigilance Compliance

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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