Pharmaceutical & Bio-Pharmaceutical Clinical Research

Pharmaceutical-&-Bio-Pharmaceutical-Clinical-Research
This comprehensive postgraduate diploma program has been developed to meet the skill requirements for effectively performing duties in pharmaceutical/ bio-pharmaceutical clinical research industries for those who want to upgrade existing skills or obtain new skills. Each area of the study will be covered in an in-depth manner for both pharmaceutical and bio-pharmaceutical sectors.

Program Starts: Fall, Spring, Summer & Winter

Admission Requirements: Any Degree or Diploma/ Equivalent

Click Here for Domestic Applications and Click Here for International Applications

The program includes the following applications:

This course is aimed to review the sciences in clinical research, which includes anatomy, physiology, pathology, molecular biology, immunology and molecular genetics.

This course is aimed to introduce the concept of Good Clinical Practice in Clinical Research. The key elements of the ICH Good Clinical Practices will be discussed, including the ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.

This course is aimed to expose students to the regulations, guidelines and standards governing the clinical research with more in-depth review of the Canadian, the United States and the European regulations. This course will also include a 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 Canadian regulatory body will also be evaluated and discussed.

This course is aimed to introduce students to clinical trials in the medical device industry. The term Medical Devices, as defined in the Health Canada Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. The course will review the protection of public health and safety with the development of useful devices intended for human use.

This course will introduce ethics and human protection in clinical research, which forms the fundamental framework for the generation of Good Clinical Practice. This is an advanced course designed to provide hands on practical knowledge for students in the role of the Research Ethics Board (REB) in safeguarding the rights, safety and wellbeing of all research subjects. The course will cover development and submission of clinical trial packages (compromising of protocol/amendments, Informed Consent Form, subject recruitment procedures, Investigator’s Brochure etc.) to REB.

This course will introduce protocol, which is an essential document in the conduct of clinical study that describes the objective, design, methodology, statistical considerations and organization of a trial. The document includes every detail of the study design, including the selection/withdrawal of study subjects, treatment of subjects, and even the retention of the clinical trial records collected during the trial. The development of clinical trial protocol is an advanced course designed to provide hands on practical knowledge for students in the development of clinical trial protocol.

This course will introduce clinical trial monitoring, which is the process of overseeing the progress of a clinical trial and ensuring that the clinical trial is conducted, recorded and reported in accordance with the protocol, SOPs, GCP and applicable regulatory requirements. This course will review the process involved in clinical trial monitoring from site identification to performing study close out visit in a clinical trial site.

This course will introduce quality assurance, which is defined in ICH GCP as “all those systematic actions that are established to ensure that the trial is performed and data are generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirement. In another words, quality assurance is also known as the “clinical police”. The course on clinical quality assurance will expose students to the quality management in clinical research and the value of audits.

This course will introduce the development and use of Standard Operating Procedures (SOPs), which are an integral part of successful quality systems. SOPs provide instructions for staff to perform a job function properly and facilitate consistency in the quality and performance of the job function between staff. The development of clinical Standard Operating Procedure is an advanced course designed to provide practical hands on knowledge for students in the development, implementation and maintenance of SOPs.

This course will introduce preparing and conducting sponsor audits and regulatory inspections, and it will introduce students to the process of preparation for the audit/inspections, hosting a regulatory inspection/ sponsor audit, and responding to observations made by the regulatory authority or the sponsor.

This course will introduce documentation, which is defined in ICH GCP as the “records in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct and record the results of a trial, the factors affecting a trial, and the actions taken. This course will review the importance of good documentation practice in clinical trials.

This course will introduce clinical data management process in clinical research including data capture, validation and cleaning, query management and coding. This course will also introduce the students to various biostatistics techniques applied to the clinical data collected during the trials. The topics covered during the course include types of data, data distribution, measurement of central tendency and variability, confidence intervals, stratification, and crossover design.

This course will introduce students to the principles of Pharmacovigilence used in clinical research. The guidelines and regulations governing Pharmacovigilence, including the spontaneous reporting of adverse events and periodic safety reports will also be discussed in the course.

This course will discuss about the laws and regulations governing clinical trials. At the end of the course, students will be able to complete the required regulatory documents (i.e. CTA, IND) for the regulatory agency, in order to obtain approval from the government for conducting clinical trials.

This course builds upon the clinical regulatory foundation built in REG01. It provides students with an understanding of the trends in the pharmaceutical industry with regards to policy making and product development. The topics also include regulatory strategies in developing a product and post approval management of the product.

This course will outline the requirements for computerized systems used at clinical sites to collect data. Students will understand the importance of electronic records and computer validation.

This course will introduce successful planning, scheduling and executing clinical study projects. This course will also introduce high level of leadership skills, and produce productive and quality results for targeted projects.

This course will outline tasks related to the use of a negotiation method, an unplanned negotiation, post negotiation self-assessment, and to plan and conduct technical and non-technical negotiations. The course will further address the proper method of negotiation while dealing with tough negotiators, angry clients/customers, extremely technical clients, the communicational aspect while dealing with different cultures, as well as in negotiating with internal clients, tough negotiators and handing any politics.

This course is aimed to introduce the Canadian Regulation PIPEDA “Privacy” in clinical studies along with privacy principals, interpretation of the principals, and applications in real work scenarios

Course Highlights:

  • 52 weeks Program
  • Hands-on Training
  • Optional Job Assistance for co-op, internship and full-time opportunities within pharmaceutical and bio-pharmaceutical and related sectors

Job Opportunities in Multiple Sectors*

Clinical Research Scientists, Clinical Research Organizers /Associates, Clinical Research Managers/ Supervisors/Directors, Regulatory Affairs Associates, Auditors, and Regulatory Affairs Managers/Supervisors/Directors

*Universities’ research sector, pharmaceutical and bio-pharmaceutical companies, hospital environment, and Clinical Research Organizations (CRO).