Complimentary eCTD Readiness Workshop

Pharma To Market Pty Ltd in collaboration with Adobe Systems Inc., are presenting complimentary half day workshops in Melbourne and Sydney to assist life science companies prepare for the TGA’s acceptance of regulatory submissions in the electronic Common Technical Document (eCTD) format.  Register Today - places are limited to two registrations per company. 

Most of the work in preparing guidance compliant eCTDs involves authoring regulatory documents in accordance with the ICH guidelines.  This workshop focuses on the use of templates and tools (including demonstrations of ISIWriter and ISIToolBox) and best practices to facilitate authoring and publishing of eCTD compliant documents – irrespective of the eCTD building tool used.

Backed by lSI’s wealth of experience in compiling nearly 1,500 eCTD submissions, Pharma To Market will address these requirements at a complimentary workshop designed specifically for life science companies in Australia.  This is the first local event where Pharma To Market and Adobe have partnered to demonstrate how we provide best-of-breed business process and implementation services to companies in Australia.

The TGA published their “Guidance for Industry on Providing Regulatory Submissions for Prescription Medicines in Electronic Format (eCTD) in Australia" in 2008.  Following an initial transition period, it is expected that submission of eCTD dossiers to the TGA will become mandatory, consistent with agencies in Europe, Canada and the USA.

Workshop Objectives:

• Identification of the requirements for authoring eCTD compliant documents
• Use of templates and software tools for authoring and publishing eCTD compliant documents (including demonstrations of Adobe Acrobat 9 Professional, ISIWriter and ISIToolBox)
• Best practices and business processes for authoring and approving documents, version control and life-cycle management

Who Should Attend the eCTD Readiness Workshop?

Industry professionals who have minimal experience with an eCTD who are presently or plan to be involved with:

• The development of an eCTD submission
• The selection of an eCTD technology solution
• Regulatory Affairs, Dossier and Document Management, IT and Data Management, Compliance, Publishing and Submission Management
• Industry professionals who prepare and provide documentation to pharmaceutical companies for inclusion in eCTD submissions