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Clinical Research

Managing GCP Issues in Your Clinical Project

Duration:

1/2 Day

Who Should Attend:

  • Individuals working within the clinical area with approximately 1 - 2 years experience monitoring and/or managing clinical trials. 
  • Individuals who already have knowledge of GCP requirements, but would like to feel more competent and confi dent in applying the principles to everyday issues.
  • Those looking to share experience and learn from colleagues from different companies that may have a different perspective.

Course Overview:

What is the rationale behind our clinical processes– and why do companies seem to interpret ICH / GCP differently? Have you found yourself discussing the requirements for the “grey areas” such as source documentation or informed consent with a colleague or study coordinator and realised your practices differ? Have you debated requirements for Investigational Product or Safety Reporting? Why do views differ? Who is right? Could you both be right?

Course Highlights:

This workshop session is intended to assist by:

  • Deconstructing clinical processes and reevaluating fundamental elements of GCP to determine appropriate solutions
  • Using evidenced based problem solving and causality assessment strategies in your decision making
  •  Raising awareness of risk assessment when managing your clinical projects to implement appropriate corrective and preventative actions

Come prepared to see those old “GCP chestnuts” from a different perspective, join into some thought provoking discussion and walk away with some tangible tips. The workshop will use a number of case studies to illustrate the issue management principles. There will be time during the session for you to bring along your own GCP chestnuts and apply the principles discussed in situations you have encountered in your clinical studies.

Entry Criteria:

The course assumes that you have a good understanding of the clinical trial process, relevant regulations and ICH-GCP. If you have any questions on your suitability for this course, do not hesitate to call the ARCS Business Office on (02) 8905 0829.

Important Information:

ARCS Australia is committed to ensuring advertised educational events go ahead. Despite all our efforts, occasionally, some events will need to be postponed or cancelled due to lack of attendee numbers. This decision is made in conjunction with the event Chairperson. Your early registration for events will assist us to assess the interest for this event in your state. We recommend for interstate travel that flexible travel arrangements are made until the event has been confirmed as ARCS Australia will not be held responsible for forfeited costs. With your support we are committed to delivering these events, so please submit your registration early.

Refunds, Transfers and Cancellations: No refunds, transfers or cancellations will be accepted within two weeks of the event. Cancellations and transfers must be in writing and will incur a 10% administration fee. Substitutions are allowed at any time and at no cost.

 

How to Register for Events

Members

  • Visit www.arcs.com.au
  • Click "Member Login" at the top of the screen
  • Enter your username and password and click "Submit"
  • Click "Training" and "Register"
  • Select the criteria - or leave blank to see all courses available
  • On the results page you can
    • click the name of the course to see more information about the course OR
    • to register for course/s, tick the box next to the course name, and click "Add to My Choices" then "Register Now"
      • The member rate will automatically be applied
  • Enter your payment details and click "Submit" (Payment must be made by credit card unless you have a prior arrangement with ARCS)
  • Once you have completed Step 6 you will be emailed a confirmation and tax invoice. A final confirmation will be sent once the course is confirmed.

Non-Members

  • Visit www.arcs.com.au
  • Click "Training" and "Register"
  • Select the criteria or leave blank to see all courses available
  • On the results page you can:
    • click the name of the course to see more information about the course or
    • Register for course/s, by clicking the tick the box next to the course name, and click "Add to My Choices" then "Register Now"
      • The non member rate will automatically be applied as you have not logged in as a member
  • Enter your contact details and click "Submit"
  • Enter your payment details and click "Submit" (Payment must be made by credit card unless you have a prior arrangement with ARCS)
  • Once you have completed Step 6 you will be emailed a confirmation and tax invoice. A final confirmation will be sent once the course is confirmed.

Please note: The CONCESSION rate is for Student and Retired ARCS Members only.