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Post Graduate Diploma

Pharmaceutical & Bio-Pharmaceutical Clinical Research – Program Outline

Program Outline

Semester 1

ICS01 – Clinical Science

  • Anatomy
  • Physiology
  • Pathology
  • Molecular Biology
  • Immunology
  • Molecular Genetics

ICS002 – Introduction to Clinical Studies (GCP)

  • The key elements of the ICH Good Clinical Practices.
  • Ethical and scientific quality standards for designing, conducting, recording the graduates will be able to demonstrate a good understanding.
  • Ethical principles related to clinical trial.
  • Roles and responsibilities of an investigator, a sponsor, a Clinical Research Organization, the Research Ethics Board, and the subjects in a clinical trial.

RGS01 – Regulations and Standards in Clinical Research

  • Regulations, guidelines and standards governing the clinical research.
  • Review of the historical context that led to the creation of the Health Canada and Food and Drug Administration (U.S.) regulations.
  • Current issues and topics in the Canadian regulatory body will also be evaluated and discussed.
  • Good understanding of Health Canada, US Food and Drug Administration, and EMEA requirements for conducting clinical trials.
  • Completion of a Clinical Trial Application to Health Canada and Investigational New Drug Application to the US FDA.

CRMD01 – Clinical Research in Medical Device

  • Clinical trials in the medical device industry.
  • Clinical research in the medical device industry.
  • Protection of public health and safety with the development of useful devices.
  • Understand the roles and responsibilities of an investigator, a sponsor, a Clinical Research Organization, and the Research Ethics Board.
  • Subjects in a clinical trial within the medical device industry

EHPC01 – Ethics and Human Protection

  • Ethics and human protection in clinical research
  • Role of the Research Ethics Board (REB) in safeguarding the rights, safety and wellbeing of all research subjects.
  • Compromising of protocol/amendments, Informed Consent Form, Subject Recruitment Procedures, Investigator’s Brochure.
  • Current issues in ethics and human protection in clinical research.

CQA01 – Quality Assurance

  • Introduction of quality assurance.
  • Quality management in clinical research and the value of audits.
  • Role/responsibility of clinical quality assurance professional in ensuring data integrity of a clinical trial.
  • Quality Management System
  • Prepare for an audit, conduct an audit, generate audit reports and follow up on corrective actions.

Semester 2

DCTM01 – Development of Clinical Trial Protocols

  • Introduction to protocol
  • The development of the clinical trial protocol
  • Importance of a protocol

PHSA01 – Preparing and Hosting Audits and Inspections

  • Preparing and conducting sponsor audits and regulatory inspections.
  • Process of preparation for the audit/inspections.
  • Introduction to documentation.

DCS01 – Development of SOP

  • Development and use of Standard Operating Procedures (SOPs)
  • Development of clinical Standard Operating Procedure.
  • Thorough knowledge of the SOP life cycle.

EG01 – Clinical Regulatory Affairs I

  • Understanding of the trends in the pharmaceutical industry.
  • Regulatory strategies in developing a product.
  • Post-approval management of the product.
  • Completion of the required regulatory documents.

PMCS01 – Project Management I

  • Introduce successful planning, scheduling and executing clinical study projects.
  • Introduce a high level of leadership skills, and produce productive and quality results for targeted projects.

PVC01 – Privacy

  • Introduction to Canadian Regulation PIPEDA “Privacy” in clinical studies.
  • Privacy principles, interpretation of the principles, and applications in real work scenarios.
  • Canadian Act PIPEDA (personal information protection and electronic documents act) and the 10 principles of PIPEDA.
  • 10 principles of Privacy to clinical trials, Interpretation of principles of PIPEDA in clinical trials, Application of PIPEDA principles to everyday clinical trials.

Semester 3

GDPC01 – Good Documentation Practices

  • GDP in completing essential documents of clinical trials.
  • Importance of GDP in recording, reviewing, verifying and approving documents in clinical trials.

CMT01 – Clinical Trial Monitoring

  • Clinical trial monitoring.
  • Overseeing the progress of a clinical trial.
  • Site identification to performing study closeout visit in a clinical trial site.
  • Understanding the basic roles and responsibilities of a sponsor, a monitor, an investigator, and a regulatory agency.

CDMB01 – Clinical Data Management and Biostatistics

  • The clinical data management process.
  • Biostatistics techniques.

PPP01 – Principles and Practices in Pharmacovigilance

  • Principles of Pharmacovigilance
  • The guidelines and regulations governing Pharmacovigilance.

REG02 – Clinical Regulatory Affairs II

  • Builds upon the clinical regulatory foundation built in REG01.
  • Understanding the trends in the pharmaceutical industry with regards to policy making and product development.
  • Regulatory strategies in developing a product and post-approval management of the product.

ERCV01 – Electronic Records and Computer Validation

  • Computer system requirements for clinical sites.
  • Electronic Recording and Computer Validation.
  • Importance of data quality.

PMCS02 – Project Management II

  • Negotiation method.
  • Unplanned negotiation.
  • Post negotiation self-assessment.
  • Plan and conduct technical and non-technical negotiations.
NACPT Pharmaceutical and Biopharmaceutical Clinical Research

Pharmaceutical & Bio-Pharmaceutical Clinical Research

Credential Awarded: PG Diploma

Duration: 48 weeks

Program Intakes:

Batch StartAdmission Deadline
Intake 1September 20, 2021 August 20, 2021
Intake 2March 14, 2022February 14, 2021

Kindly Note

Due to COVID-19, all training classes have been moved online (live, interactive, and instructor-led) or onsite until further notice. Hybrid Learning Mode will be used for programs that include hands-on training (theory will be delivered online and hands-on training will be delivered on-site). Students who wish to receive onsite instruction may request the college. Please get in touch with us for more information!

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