Audio/Presentations for CAPRA Symposium

NOW AVAILABLE!

Here is your opportunity to purchase the presentations with audio in PDF/MP3 format from the CAPRA Electronic Regulatory Process Symposium 2017.  Complete the order form below and submit by January 19, 2018, then print the confirmation email.  Payment may be made by credit card or by cheque.

Electronic Regulatory Process Symposium 2017

December 6, 2017 – Toronto

This one day symposium provided an update on the Electronic Regulatory Process activities from Health Canada and the Group on Electronic Regulatory Affairs (GERA).

Health Canada and Industry speakers presented their strategies, experiences and feedback on the Regulatory Enrolment Process (REP), Structured Product Monographs and eCTD Pilot for Clinical Trials project.  The agenda also featured implementation considerations for eCTD V4 and an introduction to the IDMP standard and its application.

Speaker Topic

Vikesh Srivastava

Associate Director, Business Informatics Division, Resource Management and Operations Directorate

Co-Chair of the Group on Electronic Regulatory Activities

Trends in Regulatory Informatics: HPFB IT Plan and Industry Perspective

 
Industry Perspective

Rocelyn Del Carmen 

Co-Chair of the Group on Electronic Regulatory Activities

Irena Pastorekova

Regulatory Affairs Specialist, Office of Submissions and Intellectual Property, Therapeutic Products Directorate

Update on Ongoing Initiatives: eCTD Pilot for Clinical Trials

Vianney Caron

Senior Chemistry and Manufacturing Evaluator and Manager, Electronic Regulatory Activities, Therapeutic Products Directorate

Katerina Paschakis

Project Manager, Business Informatics Division, Resource Management and Operations Directorate

Update on Ongoing Initiatives: Regulatory Enrolment Process (REP)

Craig Anderson

Business Analyst, Business Informatics Division, Resource Management and Operations Directorate

Update on Ongoing Initiatives: Structured Product Monograph (SPM)

Khaled Yahiaoui  

President, eCTD Now Inc.

Industry Perspective: REP and SPM
Vikesh Srivastava Introduction to IDMP

Irena Pastorekova

Craig Anderson

eCTD v4: Overview and Implementation Considerations
Panel Discussion and Closing Remarks

 

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Audio Presentations

Set(s) of audio/presentations on USB $61.95
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Deadline to order is January 19, 2018.

Order will not be shipped until payment is received.  Payment must be received by January 26, 2018.