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.
- 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
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.
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3 hours; 12:00 - 3:00 p.m. Eastern
March 7, 2011
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471