Inquiry: +1 416 412 7374Call/Text: +1 647 998 7374E-mail: info@nacptpharmacollege.com
PHARMACEUTICAL POSTGRADUATE DIPLOMA PROGRAM

Pharmaceutical & Bio-Pharmaceutical Clinical Research

Program Details

  • Program code: PHA.BIO.CLINR.PGDIP
  • Credential Awarded: PG Diploma
  • Program Duration: Full-time / 1 Year
  • Delivery Mode: On Campus
  • Program Intake: March 2021 / September 2021 / November 2021

*Please Note:Weekday and weekend schedules are available, contact the college for more details.

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 students 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 clinical research and related sectors.

JOB ASSISTANCE PROGRAM (OPTIONAL)

NACPT offers its unique job development program for all graduates. Being a part of the program will allow the graduates to work with an industry professional, individually, to obtain the maximum job opportunities in the Pharmaceutical Clinical Research industry. As part of the job development program, the career development team will help each NACPT graduate tailor the resume, prepare candidates for specific job positions, conduct mock interviews, connect with industry experts, and have exclusive access to the job market. Every qualified student will receive references on particular projects completed under this program. You will also have the opportunity to with NACPT alumni working in pharma or related sectors.

NACPT has designed this Job Development Program to help the students prepare a career plan knowing the industry better through expert advice. Please note that this program is optional and is not mandatory for graduation. Learn More.

GRANTS / SCHOLARSHIPS / EDUCATIONAL PLANS

NACPT offers various grants under the Government of Canada as well as scholarships to our students who are qualified for the same. Find out all the available grants from the link below.

Program Outline & Course Description

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.

Additional Program Info

  • Skills Acquired
  • Job Opportunities
  • Admission Requirements
  • International Students
  • Domestic Students

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.
Who Can Apply

Admission Requirements

  • Students above or at the age of 18 years
  • Graduates with a Science / Engineering / Technology Degree or Diploma / Equivalent
Admission Requirements

International Students

  • Complete application/registration form. Click here for Online Registration.
  • Attach a copy of your academic record in your native language and in official/certified English translation.
  • 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.
  • Students without an Ontario Secondary School Diploma or equivalent must write the Wonderlic Assessment Test.
  • 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.)
  • Submit your application with required documents to info@nacptpharmacollege.com
Admission Requirements

Domestic Students

  • Complete application/registration form. Click here for Online Registration
  • Attach a copy of your academic record in your native language and in official/certified English translation.
  • Students without an Ontario Secondary School Diploma or equivalent must write the Wonderlic Assessment Test.
  • 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.)
  • Submit your application with required documents to info@nacptpharmacollege.com

application procedure

Please allow for 1 – 2 business days for our administrative team to review your application.

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.

Fee Structure

For fee-related inquiries, contact us at 416-412-7374 or email us through

Mail Us

Testimonials

Dr.Taiwo Sonoiki

Graduate from Pharmaceutical & Bio-Pharmaceutical Clinical Research Post-secondary Diploma

For new immigrants like myself, the difficulty in obtaining Canadian references proves to be an important challenge, NACPT solved that problem. Year 2012.

Hired By St. Boniface General Hospital

Position: Clinical Assistant

Siva Babu Jonnalagadda

Graduate from Pharmaceutical & Bio-Pharmaceutical Clinical Research – Post-secondary Diploma

Perfect place for study under the supervision of the director, her dedication in helping students with great knowledge and with excellent industrial networks are reaping success stories of NACPT students. Wish this institute would help as many students as possible with their experienced staff, who are current professionals from Pharma industries. The director and her associates are fantastic and really helps students in difficult times. Feeling happy for being a student here. Year 2016.

Hired By Milner Health Care

Position: Intern

Sanjida Ahmed

Graduate from Pharmaceutical & Bio-Pharmaceutical Clinical Research Post-secondary Diploma

The course/training that I completed in NACPT was a post graduate diploma in Pharmaceutical and Bio-pharmaceutical Clinical Research. Fortunately I was offered a position by NACPT and its sister company Validation Tech Inc. before completing my course. The training was very inspirational, energizing bringing lots of ideas, with both substantial and in depth knowledge together with case studies, learning from experience and being fully practice oriented. The other trainees were amazing and I learned a lot from their experience and insights. I found the course very useful and hopefully be able to put some of it into practice. Year 2015.

Hired By Validation Tech Inc

Position: Director, Strategic Planning and Business Development

Lorrein Muiruri

Graduate from Pharmaceutical & Bio-Pharmaceutical Clinical Research Post-secondary Diploma

I was a fresh UofT graduate with a Bachelor’s degree in Science. I came across NACPT at the University career fair. I was not sure what Clinical Research was all about but with more understanding I joined the program. I thank God I enrolled into Clinical Research under the guidance of NACPT’s director and all the qualified instructors. Every one of them was so supportive both in academics and career paths. An additional unique advantage at NACPT was that the classes were intimate and hence easy to relate to each other as students and more to our instructors. NACPT continues to give career support and advice after graduation. They assisted fixing my resume and even provided short term co-op positions. Less than 1 year later I got hired in the field as a Clinical Research Assistant. I believe that this is just a stepping stone into higher positions. I trust that NACPT will be a great support in my career ahead. Thank you NACPT! Year 2013.

Hired By Inflamax Research Inc

Position: Clinical Research Assistant

Pradha Muruganathan

Graduate from Pharmaceutical & Bio Pharmaceutical Clinical Research – PG Diploma

It is with great pride that I draft this letter of appreciation to North American Institute of Pharmaceutical Technology (NACPT) in acknowledgement of their immense support and guidance from the onset of my training phase to my entry into the pharmaceutical industry. During 2012, I had enrolled in the Pharmaceutical and Bio-pharmaceutical Clinical Research, one of the Post-Degree Diplomas offered at NACPT. The program was designed exceptionally well to accommodate academic teaching with hands-on training experiences, through which I had enriched my understanding of the pharmaceutical industry and all the regulatory bodies that govern it. Each class was conducted by industrial experts who brought interesting insights into current and best practices within the industry. Apart from the quality – hands on training I had attained, NACPT had also helped me get a government grant in support of my work term, and also supplemented with a scholarship of $ 3000. I have also had the opportunity to work at NACPT as a Program Coordinator (co-op position), which allowed me to further strengthen my leadership and interpersonal skills. Most importantly, NACPT had set itself apart by building partnerships with various pharmaceutical companies and inviting them for on-campus hiring. It was truly a great experience and one of the greatest rewards was the number of job opportunities that had come my way upon completion of the program. Last but not the least, NACPT helped me to build confidence and prepared me thoroughly for all the interviews I had to face! As I begin a new journey within the pharmaceutical industry, I will cherish each memorable moment at NACPT for a lifetime! My hearty thanks to the dean of the department and all the instructors once again for all that you have done to help me begin a new chapter in my life. Year 2012.

Hired by Sanofi Pasteur

Position: Advanced Technician Downstream

Khalil Thompson

Graduate from Pharmaceutical and Bio-pharmaceutical Clinical Research – Post-secondary Diploma

I was an MSc graduate from UOIT when I first came across NACPT while searching the internet for post-graduate courses in the pharmaceutical industry. I was intrigued by the Career Orientation Seminar which they were providing and decided to attend. The decision to attend this seminar changed my life. After meeting the staff and professors at NACPT I knew that this was an opportunity to learn from industry experts and gain essential information about the pharmaceutical industry. From the moment I arrived at NACPT as a new student I knew this college was different due to the individualized attention given to each student, the wealth of industry knowledge each professor provided and professionalism of the learning environment. The staff and professors were always welcoming and accommodating to my schedule as I was commuting from Kitchener. After graduating and participating in the NACPT Job Development Program, which helped me update my resume and interview skills, I was presented with many more job opportunities for employment. I would recommend this college to anyone looking to gain current and relevant skills training within the pharmaceutical industry. NACPT is truly a one of a kind learning environment. Year 2013.

Hired By Apotex Inc.

Position: Quality Assurance Manager, Manufacturing and Packaging

Amanda D’Souza

Graduate from Pharmaceutical & Bio-Pharmaceutical Clinical Research – Post-Graduate Diploma

I am very proud to be a student at NACPT and to be given an opportunity to write this testimonial while still completing my program. I first came across NACPT at a career college fair while attending university. In my last year of completing B.Sc, I obtained early acceptance to NACPT with a scholarship. This school stood out to me because of the many types of programs they offered which cover multiple areas of the pharmaceutical industry. In addition to fast-track, hands-on training, I was able to connect with industry professionals who effectively guided me on my career path. With the tools support and interview preparation NACPT provided me with, I was able to obtain a full-time position with a established CRO half-way through program completion I highly recommend this program to anyone that needs industry based knowledge in working in the pharmaceutical industry in Canada, especially recent graduates and international students who need Canadian experience. NACPT is a school that puts its students first and prioritizes helping every student succeed in whatever career they choose to pursue within this industry. Year 2014.

Hired by Pharma Medica Research Inc

Position: Report Writer

Suraj Vijayaraj

Graduate from Pharmaceutical & Bio Pharmaceutical Clinical Research – Post-secondary Diploma

The college management helped me in acquiring a job with help of NACPT instructors, whose reference was much needed in the process. It helped me a lot in the long run as an international student to establish myself socially and professionally. Year 2017.

Hired by Shoppers Drug Mart

Position: Merchandiser

 

COMPANIES WHO HAVE HIRED NACPT GRADUATES

Pharmaceutical

Food

Cosmetics

Related Programs

Pharmaceutical and Biotechnology Advanced Diploma

Pharmaceutical & Biotechnology Advanced Diploma

Healthcare Program
Pharmaceutical and Biotechnology Advanced Diploma

Pharmaceutical & Biotechnology Advanced Diploma

Healthcare Program
Visit Program
Pharmaceutical Quality Control & Quality Assurance - NACPT

Pharmaceutical Quality Control & Quality Assurance

Healthcare Program
Pharmaceutical Quality Control & Quality Assurance - NACPT

Pharmaceutical Quality Control & Quality Assurance

Healthcare Program
Visit Program
Pharmaceutical Formulation and Validation Technology - NACPT

Pharmaceutical Formulation & Validation Technology

Healthcare Program
Pharmaceutical Formulation and Validation Technology - NACPT

Pharmaceutical Formulation & Validation Technology

Healthcare Program
Visit Program
NACPT Medical Office Administration

Medical Office Administration

Healthcare Program
NACPT Medical Office Administration

Medical Office Administration

Healthcare Program
Visit Program

Accreditations and Affiliations

Enquiry Form

+1 416 412 7374
+1 647 998 7374