Writing and Maintaining the Canadian CTA (Clinical Trial Application) March 2011

Mar 7, 2011
Order the DVD of this seminar

Course Description 

The Regulatory Affairs department must prepare documents that inform Health Canada about the proposed development plan; submit a CTA to initiate human clinical trials; answer questions about on-going investigations; and construct and submit any updates to the application in a concise and informative manner. Regulatory submissions are more than just writing – they encompass strategy, research, writing, organizing, and leading a team, as well as compiling, editing, publishing, and tracking of the information. When initiating a global clinical trial program, many moving parts need to be brought into harmony to ensure that compliance is achieved and that timelines are met. Course attendees will walk away with tools to help plan, write, and manage a CTA.



Learning Objectives 

  • Navigate Canadian Food and Drug Laws and Guidelines
  • Describe the basic requirements of the Clinical Trial Application, the IND equivalent in Canada
  • Identify the key documents that will be needed for the preparation of the CTA
  • Determine the timelines for review
  • Determine what is needed to amend and maintain the CTA

Who Should Attend 

  • Any part of the drug development team who wishes to know more about global drug development and the CTA submission process, such as regulatory associates and managers, quality assurance, manufacturing, clinical, project management, and pre-clinical personnel.


Meredith Brown-Tuttle, R.A.C.

Click here for complete trainer biographies 

Course Length Time 

3 hours; 12:00 - 3:00 p.m. Eastern

Course Dates 

March 7, 2011

Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471


LinkedIn twitter Facebook 

On-Demand GCP Refresher Training 

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
For details on our scenario-based practical GCP application on-demand course, click here.

GCP for Investigators

Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

For more details on this scenario-based eGCP program for investigators please click here. 

BARNETT CATALOG The Barnett Catalogue is your comprehensive guide to the myriad live, web, and custom training opportunities offered throughout the year. 

Jan - July 2014 Edition

Winter CatalogDownload Today!  

Blended Curriculum Path for the CRA, CRC, and Project Manager

BCP Cover

Download Today! 






 View Catalog of Offerings   

New Titles added every month! 
Course Alumni Save 50% 


Monitoring Clinical Drug Studies: Intermediate 

Informed Consent Content & Process Requirements for Biobanking Studies 

Auditing Techniques for Clinical Research Professionals 


10-Week CRA & CRC Beginner Program  

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance 

Use of Notes to File in Clinical Trial Essential Documentation 

10-Week Clinical Research Associate (CRA) On-Boarding Program  


2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)