The Clinical Research Institute of America in partnership with Global Research Pharma Canada/EduPharma.ca, launched the initiative to provide formal academic qualification to clinical research science professionals in Clinical Research Business Management. The global clinical research business is growing and expanding at an extraordinary pace, where clinical research professionals struggle to gain new expertise while remaining competitive in their jobs.   This is a unique program that is tailored to deliver a concise insight of the Drug Development process form the optics of clinical development, presenting clinical trial management challenges and opportunities dealing with risk, managing risk and pre-emptive crisis management. The participants will have the opportunity to learn in depth the impact of emerging technologies (EDC, EHR, ePRO) in the management of clinical trials. The program is organized to deliver knowledge based on the latest opinions from key leaders in the industry. Topics as innovation in clinical research, virtual clinical trials and biomarkers and pharmacogenomics in clinical trials will be thoroughly discussed. The future perspectives will be presented from the point of view of mergers, acquisitions, changes in regulatory environments, post marketing commitments and other challenging factors in clinical research.

 Knowledge base to be gained in this program

  • Clinical research process and regulatory perspectives, background on Global Pharmaceutical R&D Process and the Pharmacology and Safety Reporting  challenge
  • Innovation in Clinical Research, growth driven by innovation
  • Web based clinical trials-tool for excellence – Management of Web-based Clinical Studies 
  • Electronic Health Records (EHR/EMR)- challenges and advantages in clinical research
  • Risk assessment and management in clinical trials –implementation of a pre-emptive  risk management plan 
  • Virtual clinical trials –management challenges 
  • Biomarkers and Pharmacogenomics in Clinical Trials 
  • The Biotech outlook 
  • Clinical Trials impact during mega mergers and acquisitions 
  • The Future Perspectives in Clinical Research, beyond 2020 

 Certificate

The participant must attend all workshops to be eligible to obtain the Master Certificate at the end of the program.

Application Process

The applicant should have at least and equivalent of a four year program / Bachelor ’s degree in Science or Health Related discipline and relevant work experience.

To enrol in this Master Certificate Program, the applicant should submit the form electronically together with the deposit. A confirmation letter will be emailed and mailed to the applicant indicating the details of the program and location of the workshops.

We encourage prospective candidates to enrol early since the spaces are filled fast.  A U$S 1,000.00 deposit is required at the time of enrolment. The deposit is 75% refundable until September 1st. After that is 50% refundable.

 Who will benefit the most from this program?

The professionals who will benefit the most from this program are Clinical Research Project Managers/Directors, Clinical Project Leaders, Sr. Clinical Research Associates, Clinical Data Managers, Quality Assurance Managers, and Regulatory Managers/Directors, who are willing to expand their horizon and formally obtain qualifications that enhance their management capabilities and also will assist them in advancing in their careers.  Professionals in other areas of the industry who wishes to enter the exiting world of drug development are also encouraged to participate.

 

Features of the program

 

Duration

3 months /Weekend workshops

Total of 6 weekend workshops

Start date

September 15, 2012

End date October 10, 2012

Scheduling

One Weekend Day

Saturday 8:00am- 4:00pm twice a month

Location

Toronto, Ontario, Canada

 

Fees

U$S 8500.00 +HST

includes all materials and workshop luncheons

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