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 principals, 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.

PHA.BIO.CLINR.PGDIP

Pharmaceutical & Bio-Pharmaceutical Clinical Research

Credential Awarded: PG Diploma

Duration: 48 weeks

Program Intakes:

Intake 1	MAR 27th, 2023
Intake 2	SEP 04th, 2023

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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