eRA 2011 North America

Get ready for the new ERA of electronic regulatory communications!

Please join us for eRA 2011, the most comprehensive forum for learning about the latest developments and plans concerning Regulatory Affairs and related areas.

eRA 2011 will be an interactive gathering where you will benefit from extensive presentations, detailed solution demonstrations and comprehensive client case studies from some of the industry’s thought-leaders. There will be ample opportunity to interface directly with EXTEDO executives during the conference at pre-scheduled meetings or during the many social events planned. Network and share experiences with your peers and learn about relevant solutions offered by EXTEDO sponsors in the demo area.

The beautiful Loews Portofino Bay Hotel in Orlando, Florida was chosen as our host venue, based on its convenient location and excellent reputation for service. eRA 2011 kicks off with a Welcome Reception on Sunday, 27 February and continues through mid-afternoon on Tuesday,1 March.

We look forward to welcoming back those of you who attended the “OPENeCTD forum” in Nice, France, and to welcoming new clients who have since joined the EXTEDO User Community.

Agenda:

Sunday, 27 February

05:00 - 07:00 p.m. Welcome Reception in Sponsor Demonstration Area

Monday, 28 February

08:30 Welcome: Tore Bergsteiner, Chief Executive Officer, EXTEDO

08:45 Keynote Speaker: “Where Are We Now? The Last 10 Years of eRegulatory Developments”
(Steve Scribner, International Life Science Solutions)

09:15 EU Regulatory Landscape: “Planning Successful Multi-country eCTD Submissions”
(Hans van Bruggen, eCTD Consultancy)

10:00 Coffee Break

10:30 eCTD in European and Middle Eastern non-ICH Countries: Tore Bergsteiner and Dr. Anna Lutomska:
“An Update on the Most Recent Developments”

11:15 The latest from the FDA: “Preparing for the New Module 1 and Validation Criteria”
(Harv Martens, EXTEDO)

12:00 Lunch

01:30 eCTD Publishing: “Effective strategies for creating compliant documents”
(Antoinette Azevedo, e-Submissions Solutions.com)

02:15 eCTD Module 3: “Best Practices for Successful Lifecycle Management of the CMC Data”
(Deanna Murden, ePharmaCMC, LLC)

03:15 Coffee Break

03:45 eCTD Modules 4 and 5: “Study Reports for Multi-region Submissions”
(Ted Hanebach, CanReg)

04:30 Panel Discussion & Q&A

05:00 End of Day 1 Prsentations

07:00 Dinner

Tuesday, 01 March

08:30 Recap and Product Management Overview: Martin Schmid, Managing Director, EXTEDO

09:00 Customer Success Stories

• CanReg: Ted Hahnebach
• Cytochroma: Malcom McConachie
• QUMAS: Patricia Santos-Serrao

10:30 Coffee Break

11:00 Partner Presentation Court Square Group and Microsoft – Keith Parent and Les Jordan

12:00 Lunch

01:30 EXTEDO eCTDmanager, EURS is Yours and GECCO wish list - open discussion, new features, roadmap:
Oliver Bojahr, VP Global Products, EXTEDO

03:00 Q&A and Closing Remarks: Tore Bergsteiner, EXTEDO

03:30 End of the Conference

Venue

Loews Portofino Bay Hotel in Orlando, Florida, US

Located at Universal Orlando, Loews Portofino Hotel is just steps away from some of America’s favorite theme parks. Just 15 minutes from the Orlando International Airport, the luxury hotel in Orlando affords easy access to surrounding restaurants and attractions for easy family travel.

Registration

For more details and registration, please click on www.eRA2011.org .

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