AAPS’ Clinical Research online courses are designed to develop specialized knowledge and skills required to; write study protocols, monitor and manage clinical trials, and to conduct drug safety and pharmacovigilance activities. This hands-on training approach includes drafting adverse reaction reports and preparing periodic safety update reports.
These courses are focused on the global healthcare system as well as the Canadian healthcare system, Canadian regulatory agencies, health care legislation, international guidelines, and standard operating procedures (SOP). Using practical and current real cases, AAPS integrates a unique approach and provides students with the foundation and practical knowledge to formulate a sound clinical development plan; ensure clinical trial data is credible and accurate; and that the rights, integrity and confidentiality of trial subjects are protected.
A well-trained and knowledgeable Clinical Research professional plays a vital role in protecting the study participant and the general population for marketed drugs and in helping to reduce the time between drug development and marketing approval.
Successful candidates will also receive an online certificate per completed module:
- The Canadian Pharmaceutical Industry: Big Picture
- Introduction to Clinical Research and Drug Safety
- Introduction to Statistical Analysis
- Clinical Pharmacology and Clinical Safety Assessments
- Clinical Research Regulations and Good Clinical Practices (GCP)
- Legislations, Ethics and Good Pharmacovigilance Practices (GVP)
- Pharmaceutical Biotechnology
- Introduction to Pharmacovigilance Activities and Pharmacoepidemiological Studies
- Medical Devices
- Organization of Clinical Trials and Clinical Monitoring Plan Development
- Clinical Project Management and Project Chart Development
- Clinical Data Acquisition and Data Management
- Drug Lifecycle Safety Management and Pharmacovigilance Compliance
- Clinical Research SOP Development
- Clinical Study Protocol and Investigator’s Brochure Development
- Clinical Research for Medical Cannabis
- GCP and GVP Inspections and Audits
- Global Clinical Research and Pharmacovigilance
- Clinical Research, Drug Safety and Pharmacovigilance Project
To register, enroll into any online course or contact us via telephone at 416-502-2277 or by email at info@aaps.ca.