w00t! It's that time again... for the 7th annual Electronics Submissions conference. Hmm, I don't remember it ever being called that before..."Electronics Submissions conference" rather than just "DIA: eCTD". An homage to the fact that RPS is (maybe) barreling down on us like Troy Polamalu?
In the spirit of Voting Day, I am going to list all of the sessions that are going head to head with one another and cast my vote for the one that I would/might attend.
Thursday
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Thursday, Nov 6 at 1:30pm
Candidate A: The Switch to eCTD (case studies)/Getting Started
Candidate B: RPS/Future eCTD/ICH
Personally, I have been to more eCTD case studies, business process overviews, etc. than I care to admit (...slow learner). The slogan of this conference is "The Adventure Continues", so I am going to choose Candidate B, which is clearly more adventurous. (Disclaimer: Newbies might be better served to go with A.)
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Thursday, Nov 6 at 3:30pm
Candidate A: Outsourcing Solutions
Candidate B: Effective eCTDs:Maximizing Resources, Reusing, Documents, Facilitating Reviews
Tough choice. Candidate B has a representative from CDER that should be able to tell me what I can do to make the reviewer's life easier. Making the reviewer's life easier = faster review = huge bonus from my boss = retire in the Bahamas. But then I remember that I'm not a drug sponsor, I'm a software guy. So I choose Candidate A so I can hear about Cadence's experiences with Software as a Service.
Whew, long day. I've earned a beer at the networking reception.
Friday
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Friday, Nov 7 at 8:30am
Candidate A: Assuring Compliance of Nonclinical and Clinical Study Reports and Datasets for ECTD Submissions (mouthful!)
Candidate B: Strategies for both US and Global eCTD Submissions
Let's assume that the after-effects of the networking reception aren't too bad and I wake up motivated to attend a session at 8:30am . Well, the choice is easy for me. Because I am a super advanced eCTD ninja, I go with Candidate B and proceed to have my mind blown by the complexities that are introduced when I start working with eCTDs in multiple regions. Newbies should certainly choose Candidate A.
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Friday, Nov 7 at 10:30am
Candidate A: Managing the Process
Candidate B: Data Standards/CDISC
Hmm, another tough decision... On one hand, Candidate A might turn out to be too simplistic for me. The project planning presentation could be interesting, though. However, Candidate B is very focused on CDISC, which although an important part to the process, is a part that doesn't directly affect what I do. I choose Candidate B because conference time is a time to be adventurous and learn new things.
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Friday, Nov 7 at 1:30pm
Candidate A: Practical Publishing of eCTD
Candidate B: Technology, Compliance, and Their Impact
Well, by now you probably know which one I will choose. As a hopeless technophile, I have to choose Candidate B because of the phrase "...as well as issues and challenges that have come up with the new [eCTD] validation criteria." Looking at Candidate B though, I think most sponsors, reg ops/affairs staff, etc. will want to choose this one. Small company reps will be interested in "Publishing on a Shoestring budget" (especially in this economy) and large company reps will be interested in "How to Create a Paperless Publishing Department".
After the conference, spend a couple of extra days in SD soaking up the sun and playing golf at Torrey Pines. Then fly back home and leave some comments on this blog with your experiences from DIA eCTD! (please)
Final edit: source material for this blog can be found here.
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