Clinical Research for the IT PRO (Information Technology Professional)  

Coming soon

OBJECTIVES

We at EduPharma identified a critical need to provide IT professionals with the essential knowledge to effectively support clinical trial activities. This course is designed to provide training in Clinical Research and Drug Development to IT professionals who play a critical role of providing IT support for clinical research management. Clinical research is a highly regulated activity, and the IT professionals who support with new technologies necessitates to be aware of the main regulatory requirements for running clinical trials as well as how drug development is performed.

Our program provides in a very concise manner all the information necessary to educate IT professionals in Clinical Research. This is a hands on course based in case studies.


OUR PROGRAM

The main topics of our program include:

  • The Drug Development Process
  • Good Clinical Practices
  • Data management and resolution in clinical research
  • Project Management in Clinical Research
  • Regulatory compliance in Clinical Trials
  • Electronic Health/Medical Records in Clinical Research
  • Requirements for IT systems: 21 CFR 11, part 11 EU
  • How IT can assist to run smoothly clinical trials
  • Auditing Clinical Trials, the role of the IT support expert
  • Clinical Research and Cloud systems
  • Workshop, understanding the monitoring process in an electronic environment, paper vs. electronic

Who should attend

We encourage that all IT support personnel attend to this session as well as:

  • Pharmaceutical and hospital IT managers and support personnel
  • Pharmaceutical and hospital IT maintenance and data archiving and backup
  • IT infrastructure designers, hospital and pharmaceutical
  • Pharmaceutical and hospital Data managers
  • Graduate IT professionals who are willing to enter the pharmaceutical R&D world
  • all clinical research professionals interested to increase awareness on IT  and clinical trials
  • regulatory representatives
This course is IN CLASSROOM style, to allow the participants interact actively with the instructor. 

Our instructor

Dr. Vera Madzarevic is a 20+years veteran in the pharmaceutical and academic research field, with extensive hands on knowledge of the clinical trials process and regulatory compliance. She also specialized in training professionals in clinical research globally. She is the author of the book:Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections, (2010), Wiley.

TUITION FEES: $ 775.00 + HST REGISTER NOW