Achieving Efficiency and Compliance in Electronic Submissions
We’ve had several good eCTD-related conferences lately. I’ll be providing some updates on them in my next blog entry, but first I wanted to mention an upcoming conference that sounds really good. This is the Cambridge Healthtech Institute conference: eCTD 2010: Achieving Efficiency and Compliance in Electronic Submissions.
This conference will be held March 10, 2010 at the Crowne Plaza Philadelphia Downtown in Philadelphia (which is almost across the street from our GlobalSubmit office).
I’m looking forward to attending this conference as I know many of the speakers and their presentations are excellent. Some of the presentations on the agenda include:
- How to Prepare Your Product Dossier for Global Simultaneous eCTD/CTD Submissions – A Look at Tools, Tips and Taking the Mystery Out of Submission Planning and Publishing
- Case Study: Global Submission Management from Concept to Realization
- Taking eCTDs off the Critical Path to Drug Development
- Working with an eCTD Vendor: Best Practices and Lessons Learned
- Electronic Signatures and Regulatory Processes, What the Agencies are Saying [This should be interesting – Tim Buxton of EMEA made a remark yesterday at EU DIA EDM in Vienna that “the storm for eSig is around the corner – ignore it at your own peril.”]
- Achieving Efficiency through Rounding Out Submission Standards: Format, Data, and Content Standards
- Current Challenges and Implications of eCTD Implementation
There are also panel discussions and ask the experts sessions.
For those of you involved in clinical trials, CHI is holding a co-located Electronic Data in Clinical Trials on March 8-9.
When I spoke to Jim Prudhomme of CHI concerning registration, he alerted me to the early discount for those who register by December 11 via the conference website or by calling 781-972-5400.