OPENeCTD formerly - Extedo
OPENeCTD formerly - Extedo
OPENeCTD formerly - Extedo
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<strong>formerly</strong><br />
<strong>OPENeCTD</strong><br />
eRegulatory Affairs 2011<br />
Get ready for the new ERA of electronic regulatory communications!<br />
CONFERENCE ANNOUNCEMENT<br />
28 February – 01 March 2011<br />
Loews Portofino Bay Hotel, Orlando, FL, USA
<strong>formerly</strong><br />
<strong>OPENeCTD</strong><br />
About the eRA (<strong>formerly</strong> <strong>OPENeCTD</strong> forum)<br />
Please join us for eRA 2011, the most comprehensive forum for learning about<br />
the latest developments and plans concerning Regulatory Affairs and related<br />
areas.<br />
eRA 2011 will be an interactive gathering where you will benefit from extensive<br />
presentations, detailed solution demonstrations and comprehensive client<br />
case studies from some of the industry’s thought-leaders. There will be ample<br />
opportunity to interface directly with EXTEDO executives during the conference<br />
at pre-scheduled meetings or during the many social events planned. Network<br />
and share experiences with your peers and learn about relevant solutions<br />
offered by EXTEDO sponsors in the demo area.<br />
Who should participate?<br />
eRA 2011 will particularly benefit professionals who work in Pharmaceutical<br />
Drug Regulatory Affairs or Dossier Assessment and Registration offices –<br />
directors and experts of regulatory affairs and dossier review, as well as<br />
IT managers focused on introducing IT systems for pharmaceutical regulatory<br />
processes. Experts who are involved in the compilation, publishing and<br />
reviewing of regulatory submissions will also benefit by attending.<br />
Get ready for the new ERA of electronic regulatory communications!<br />
eRegulatory Affairs 2011 / CONFERENCE ANNOUNCEMENT<br />
2
<strong>formerly</strong><br />
<strong>OPENeCTD</strong><br />
Agenda:<br />
Sunday, 27 February<br />
Welcome Reception in Sponsor<br />
Demonstration Area<br />
Monday, 28 February (09:00 a.m. – 05:30 p.m.)<br />
• Welcome:<br />
Tore Bergsteiner, Chief Executive Officer, EXTEDO<br />
• Keynote:<br />
Steve Scribner, International Life Science Solutions:<br />
“Where Are We Now? The Last 10 Years of eRegulatory Developments”<br />
• EU Regulatory Landscape:<br />
Hans van Bruggen, eCTDconsultancy: “Planning Successful<br />
Multi-country eCTD Submissions”<br />
• eCTD in European and Middle Eastern non-ICH Countries:<br />
Tore Bergsteiner, EXTEDO: “An Update on the Most Recent<br />
Developments”<br />
• The New eCTD Module from the FDA:<br />
Harv Martens, EXTEDO: “Considerations for Transitioning to the<br />
New Module 1”<br />
• eCTD Publishing:<br />
Antoinette Azevedo, eSubmissionsSolutions.com: “Effective strategies<br />
for creating compliant documents”<br />
• eCTD Module 3:<br />
Deanna Murden, ePharmaCMC, LLC: “Best Practices for Successful<br />
Lifecycle Management of the CMC Data”<br />
• eCTD Modules 4 and 5:<br />
Ted Hanebach, CanReg: “Study Reports for Multi-region Submissions”<br />
• Panel Discussion & Q&A<br />
Tuesday, 01 March (09:00 a.m. – 04:00 p.m.)<br />
• Customer Success Stories / Lessons Learned<br />
(EXTEDO customers will show how they solved regulatory issues using<br />
the EXTEDOsuite)<br />
• Topics defined<br />
by a group of EXTEDO customers<br />
• EXTEDO eCTDmanger, EURS is Yours and GECCO User Group<br />
Meeting<br />
(wish list – open discussion, new features, roadmap) – Oliver Bojahr,<br />
VP Global Products, EXTEDO<br />
eRegulatory Affairs 2011 / CONFERENCE ANNOUNCEMENT<br />
3
<strong>formerly</strong><br />
<strong>OPENeCTD</strong><br />
Information<br />
Location<br />
Loews Portofino Bay Hotel<br />
5601 Universal Blvd<br />
Orlando, Florida, 32819, USA<br />
Phone: (888) 430-4999<br />
http://www.loewshotels.com/en/Portofino-Bay-Hotel/GroupPages/EXTEDO<br />
Accommodation<br />
EXTEDO has negotiated a block of rooms at the Loews Portofino Bay Hotel<br />
at the special discounted rate of $229/night for eRA attendees.<br />
Please reserve your room by going to:<br />
http://www.loewshotels.com/en/Portofino-Bay-Hotel/GroupPages/EXTEDO<br />
Registration<br />
Please register online: www.eRA2011.org –> Registration<br />
Contact<br />
eRA2011 Conference<br />
c/o EXTEDO GmbH<br />
Einsteinstrasse 30<br />
85521 Ottobrunn<br />
Germany<br />
Ellie Stone, Conference Manager<br />
Phone: +1 508 366 4858<br />
Cell: +1 508 439 9182<br />
Email: stone@eracon.org<br />
www.eRA2011.org<br />
Fee<br />
Early Bird (available until 21 January): USD: 995<br />
Standard: USD 1,195<br />
(+ VAT, including conference bag and materials, certificate,<br />
breakfast, lunch and coffee & tea breaks, dinner on day 1)<br />
Confirmation<br />
Register early. Since space is limited please await the written<br />
confirmation of your registration.<br />
Cancellation<br />
Your notice of cancellation must be received in writing (letter or fax)<br />
10 working days before the conference in order to transfer your<br />
event pass to someone else in the waiting list.<br />
We will be pleased to transfer your registration to another member<br />
of your company at any time. No cancellations will be accepted<br />
after that date.<br />
eRegulatory Affairs 2011 / CONFERENCE ANNOUNCEMENT<br />
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