Clinical Research, Pharmacovigilance and Regulatory Affairs

Duration: 45 Weeks

The demand has never been greater for professionals who can help companies ensure compliance with applicable laws and regulations in the development and commercialization of new drugs and healthcare products. The Clinical Research, Pharmacovigilance and Regulatory Affairs program will provide you with knowledge and insight into the most recent developments in the clinical research, pharmacovigilance and regulatory affairs field. You will learn current regulatory and pharmacovigilance research current clinical research topics including Good Clinical Practices (GCP), Regulatory submission, pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP), and quality assurance concepts in clinical trials and pharmacovigilance. As a student in this program you will benefit from an applied and practical approach to training and develop a network of industry contacts ahead of graduation.

To register for In Class, contact us via telephone at 416-502-2277 or by email at info@aaps.ca

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Diploma Program: Please directly contact AAPS for Registration and Payment.

Individual Certificate Courses: Please see below for online availability. The online courses are registered and paid for individually.

Course Outline

Diploma in Clinical Research, Pharmacovigilance and Regulatory Affairs
Code Course
CR09 The Canadian Pharmaceutical Industry: Big Picture In Class Online
PRA1008 Introduction to Regulatory Affairs In Class Online
GMP1001 Introduction to Good Manufacturing Practices – Level I In Class Online
CR013 Clinical Pharmacology and Clinical Safety Assessments In Class Online
CR014 Clinical Research Regulations and Good Clinical Practices (GCP) In Class Online
CR015 Legislations, Ethics and Good Pharmacovigilance Practices (GVP) In Class Online
PRA2013 Regulatory Affairs Generic Drugs In Class Online
PRA3005 Medical Devices In Class Online
CR019 Organization of Clinical Trials and Clinical Monitoring Plan Development In Class Online
CR020 Clinical Project Management and Project Chart Development In Class Online
CR021 Clinical Data Acquisition and Data Management In Class Online
CR023 Drug Lifecycle Safety Management and Pharmacovigilance Compliance In Class Online
TWR3009 Technical Writing and Scientific Communication In Class Online
CR025 Clinical Study Protocol and Investigators’ Brochure Development In Class Online
PRA3008 Global Regulatory Strategies In Class Online
PRA3003 Natural Health Products In Class Online
CR028 Global Clinical Research and Pharmacovigilance In Class Online
PRA2008 Regulatory Submission In Class Online
CR030 Clinical Research, Drug Safety and Pharmacovigilance Project In Class Online
PRA3004 Regulatory Affairs for Biologics/Biotechnology Products In Class Online

AAPS graduates from the Clinical Research, Drug Safety and Pharmacovigilance program pursue careers in the Pharmaceutical, Biotechnological, Medical devices, Cosmetics, Natural health Products, and Allied industries.

Qualify to start your career in:

  • Clinical Research
  • Pharmacovigilance
  • Pharmaceutical project management
  • Clinical data management
  • Pharmacoepidemiology data management

Example of careers in the field of Clinical Research and Pharmacovigilance:

  • Clinical Research Coordinator
  • Pharmacovigilance data management Associate
  • Clinical Research Associate
  • Pharmacovigilance Associate
  • Clinical Data Management Associate
  • Clinical Research Project Leader
  • Pharmacovigilance Project leader
  • Clinical Research Monitor
  • Medical Information Associate
  • Pharmacovigilance Officer
  • Quality Control in Clinical Research
  • Quality Assurance in Clinical Research
  • Quality Assurance in Pharmacovigilance
  • Auditor in Clinical Research and Pharmacovigilance

AAPS graduates of Clinical Research, Drug Safety and Pharmacovigilance post-graduate diploma qualify for Certified Clinical Research Professional – CCRP Certification awarded by Society of Clinical Research Associates (SOCRA). For more detail contact AAPS at 416-502-2277

For more information on benefit of CCRP certification please visit https://www.socra.org/certification