Pharmaceutical & Bio-Pharmaceutical Clinical Research

HEALTHCARE PROGRAM

Program code: PHA.BIO.CLINR.PGDIP

Credential Awarded: PG Diploma

Program Duration: 1 Year

Delivery: Full-time

Delivery Mode: On campus

Program Intake: March, 2021 / September, 2021 / November, 2021

Please Note: Weekday and Weekend Schedules are available, Please contact the college for more                            details

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Program Overview

The Pharmaceutical & Bio-Pharmaceutical Clinical Research Postgraduate diploma is tailored to prepare graduates to meet the Pharmaceutical research industry standards. This integrated postgraduate diploma in clinical research and pharma extensively covers a wide range of subjects like Regulations and Standards in Clinical Research, Quality Assurance, Clinical Trial Monitoring, Development of Protocols and SOPs, Privacy, Regulatory Affairs, Medical Devices, Clinical Data Management and Biostatistics, Project Management and  Pharmacovigilance. 

Successful completion of this  clinical research course can help the student establish their career as Clinical Research Associates, Scientists, Clinical Research Organizers, Clinical Research Managers, Supervisors, Directors, Regulatory Affairs Associates, Auditors,  Principal Investigators and Regulatory Affairs Managers, Supervisors /Directors. NACPT also provides optional job assistance along with resume preparation and learning interview tactics and tips.

NACPT’s commitment to perfection is demonstrated through the faculty members who are recognized experts. Our curriculum  of pharmaceutical clinical research engages the students in experiential learning through intensive training, industrial workshops, guest speaker’s sessions, project work along pharmaceutical studies to foster their growth in the Pharmaceutical & Bio-Pharmaceutical sector. 

Pharmaceutical & Bio-Pharmaceutical Clinical Research

Program Outline and Course Description

Semester 1

 

Course Code

Course Title

GCCP01
Good Manufacturing and Good Clinical Practices
    1. Course Description
    2.           1. Anatomy
    3.           2. Physiology
    4.           3. Pathology
    5.           4. Molecular Biology
    6.           5. Immunology
    7.           6. Molecular Genetics

ICS002
Introduction to Clinical Studies (GCP)
    1. Course Description
    2.          1. The key elements of the ICH Good Clinical Practices.
    3.          2. Ethical and scientific quality standard for designing, conducting, recording The graduates
    4.           will be able to demonstrate a good understanding.
    5.          3. Ethical principles related to clinical trial.
    6.          4. Roles and responsibilities of an investigator, a sponsor, a Clinical Research Organization,
    7.          the Research Ethics Board, and the subjects in a clinical trial.

RGS01
Regulations and Standards in Clinical Research
      1. Course Description
      2.          1. Regulations, guidelines and standards governing the clinical research.
      3.          2. Review of the historical context that led to the creation of the Health
      4.          Canada and Food and Drug Administration (U.S.) regulations.
      5.          3. Current issues and topics in the Canadian regulatory body will also be
      6.          evaluated and discussed.
      7.          4. Good understanding of Health Canada, US Food and Drug Administration, and EMEA
      8.          requirements for conducting clinical trials.
      9.          5. Completion of a Clinical Trial Application to Health Canada and Investigational New Drug
      10.          Application to the US FDA.

CRMD01
Clinical Research in Medical Device
    1. Course Description
    2.          1. Clinical trials in the medical device industry.
    3.          2. Clinical research in the medical device industry.
    4.          3. Understand the roles and responsibilities of an investigator, a sponsor, a Clinical
    5.               Research Organization, the Research Ethics Board.
    6.          4. Subjects in a clinical trial within the medical device industry

EHPC01
Ethics and Human Protection

CQA01
Quality Assurance

Semester 2

 

Course Code

Course Title

DCTM01
Development of Clinical Trial Protocols
    1. Course Description
    2.           1. Introduction to protocol
    3.           2. The development of clinical trial protocol
    4.           3. Importance of a protocol

PHSA01
Preparing and Hosting Audits and Inspections
    1. Course Description
    2.          1. Preparing and conducting sponsor audits and regulatory inspections.
    3.          2. Process of preparation for the audit/inspections.
    4.          3. Introduction to documentation.

DCS01
Development of SOP
    1. Course Description
    2.          1. Development and use of Standard Operating Procedures (SOPs)
    3.          2. Development of clinical Standard Operating Procedure.
    4.          3. Thorough knowledge of the SOP life cycle.

EG01
Clinical Regulatory Affairs I
    1. Course Description
    2.          1. Understanding of the trends in the pharmaceutical industry.
    3.          2. Regulatory strategies in developing a product.
    4.          3. Post approval management of the product.
    5.          4. Completion of the required regulatory documents.

PMCS01
Project Management I
    1. Course Description
    2.          1. Introduce successful planning, scheduling and executing clinical study projects.
    3.          2. Introduce a high level of leadership skills, and produce productive and quality results
    4.           for targeted projects.

Semester 3

 

Course Code

Course Title

CMT01
Clinical Trial Monitoring
    1. Course Description
    2.           1. Clinical trial monitoring.
    3.           2. Overseeing the progress of a clinical trial.
    4.           3. Site identification to performing study closeout visit in a clinical trial site.
    5.           4. Understanding the basic roles and responsibilities of a sponsor, a monitor,
    6.           an investigator, and a regulatory agency.

CDMB01
Clinical Data Management and Biostatistics
    1. Course Description
    2.          1. The clinical data management process.
    3.          2. Biostatistics techniques.

PPP01
Principles and Practices in Pharmacovigilance
    1. Course Description
    2.          1. Principles of Pharmacovigilance
    3.          2. The guidelines and regulations governing Pharmacovigilance.

REG02
Clinical Regulatory Affairs II
    1. Course Description
    2.          1. Builds upon the clinical regulatory foundation built in REG01.
    3.          2. Understanding the trends in the pharmaceutical industry with regards to policy
    4.          making and product development.
    5.          3. Regulatory strategies in developing a product and post-approval management
    6.          of the product.

PMCS02
Project Management II
    1. Course Description
    2.          1. Negotiation method.
    3.          2. Unplanned negotiation.
    4.          3. Post negotiation self-assessment.
    5.          4. Plan and conduct technical and non-technical negotiations.

PVC01
Privacy
    1. Course Description
    2.          1. Introduction to the Canadian Regulation PIPEDA “Privacy” in clinical studies.
    3.          2. Privacy principles, interpretation of the principals, and applications in real work scenarios.
    4.          3. Understanding of ICH GCP and the requirement for privacy, Canadian Act PIPEDA,
    5.              10 principles of PIPEDA.

Skills Acquired

A comprehensive skill set in the following verticals of  cannabis and pharmaceutical clinical research is developed through this PG program:

● Clinical Studies

● Development of SOP for Clinical Research

● Pharmacovigilance 

● Data Management 

● Biostatistics

● Project management

● Privacy, Ethics and etc.

● Pharmaceutical and cannabis regulatory requirements

● Regulatory Affairs

Job opportunities

Students can get the following pharma clinical research jobs after this program :

● Regulatory Affairs Area: 

  • Regulatory Affairs Associates, Reviewers, Auditors, Managers / Supervisors / Directors.

● Clinical Research Area: 

  • Clinical Research Scientists, Clinical Research Organizers / Associates, Managers / Supervisors/Directors.

● Quality Assurance Area:

  • Document Reviewers, QA Coordinators, Trainers, SOP  Writers, Auditors, Supervisors, and Managers. 

Admission Requirements

WHO CAN APPLY ?

 

Student above or at the age of 18 years &

Graduates with a Science/Engineering/Technology Degree or Diploma/Equivalent

International Students

  1. Complete application/registration form. Click here for Online Registration.
  2. Attach a copy of your academic record in your native language and in official/certified English translation.
  3. Students from countries where first language is not English must provide proof of English proficiency: IELTS Academic: an overall minimum score  of 6.0 (no single test score below 5.0), TOEFL: 550 (paper based) 213 (computer based) or 88 (internet based), CAEL: overall band score of 60.
  4. Students without an Ontario Secondary School Diploma or equivalent must write the Wonderlic Assessment Test.
  5. Students who are or above 18 years of age should pass the Wonderlic Contemporary Cognitive Ability Test. (The assessment will help measure the cognitive ability and problem-solving aptitude of prospective employees for a range of occupations.)
  6. Submit your application with required documents to info@nacptpharmacollege.com

Domestic Students

  1. Complete application/registration form. Click here for Online Registration
  2. Attach a copy of your academic record in your native language and in official/certified English translation.
  3. Students without an Ontario Secondary School Diploma or equivalent must write the Wonderlic Assessment Test.
  4. Students who are or above 18 years of age should pass the Wonderlic Contemporary Cognitive Ability Test. (The assessment will help measure the cognitive ability and problem-solving aptitude of prospective employees for a range of occupations.)
  5. Submit your application with required documents to info@nacptpharmacollege.com

Fee Structure

For fee-related inquiries, contact us at 416-412-7374 or email us through
info@nacptpharmacollege.com.

Application Procedure

  • 1. Please allow for 1-2 business days for our administrative team to review your application.
  • 2. Once your application has been reviewed, our administrative team will contact you to book a meeting for any grant application (if applicable) or to create your payment plan.

    Enquire now




    +1 416 412 7374  +1 647 998 7374

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