In two weeks a group of high-level regulatory affairs professionals, including from Health Canada, will be sharing knowledge in a Mississauga, Ontario hotel – and one of the experts leading their discussions will be our own The Regulatory Affairs Professionals Society (RAPS) symposium is being sponsored by LORENZ Life Sciences, a global leader in electronic submissions and one of Adlib’s life sciences partners. It is the first time that an Adlibber has presented at a RAPS event.
Scott, who is the Director of Product Management at Adlib, will hold a workshop at 1:45 p.m. on Tues. June 22, 2010 titled “Populating Your eCTD – Submission Document Rendering.” Topics will include:
- How the success of your eCTD submission depends on regulatory publishing compliance with the eCTD guidelines and with the format of PDF files contained in it
- How to reduce document QA times, cut costs, speed up submission preparation, and reduce the potential for rejection due to formatting errors – by delivering flawlessly formatted PDFs that meet regulatory standards
- How some of the largest global pharmaceutical companies centralize and manage their document rendering process to reduce time-to-market and improve profitability
Emerging Global Trends in E-Submissions
- The emerging trends in electronic submissions in Canada as compared with other global regulatory leaders
- A critical examination of the eCTD from the perspective of the Health Canada reviewer, pro-eCTD industries, reluctant industries, and regulatory consultants
- Practical aspects of the eCTD including a method of eCTD tool selection that will address company-specific needs, life-cycle management, and cost effectiveness
- The challenges facing companies transitioning to the eCTD
- The permanence of the eCTD in product lifecycle
- A general demonstration of the eCTD tool currently supported by Health Canada Practical aspects and issues related to submission compilation (including hyperlinking, bookmarking, and publishing issues)
- Life-cycle management within the eCTD Validation issues
Part of the reason for holding this event – on Tuesday, June 22, 2010 at the Delta Meadowvale Hotel in Mississauga, Ontario – is to discuss the potential for launching a RAPS networking group in the Greater Toronto Area.
Join us, to give your input and learn more about getting involved… at the very least, you’ll go home with some interesting perspectives and new information about the eCTD.