OPENeCTD formerly - Extedo

extedo.com

OPENeCTD formerly - Extedo

formerly

OPENeCTD

eRegulatory Affairs 2011

Get ready for the new ERA of electronic regulatory communications!

CONFERENCE ANNOUNCEMENT

28 February – 01 March 2011

Loews Portofino Bay Hotel, Orlando, FL, USA


formerly

OPENeCTD

About the eRA (formerly OPENeCTD forum)

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.

Who should participate?

eRA 2011 will particularly benefit professionals who work in Pharmaceutical

Drug Regulatory Affairs or Dossier Assessment and Registration offices –

directors and experts of regulatory affairs and dossier review, as well as

IT managers focused on introducing IT systems for pharmaceutical regulatory

processes. Experts who are involved in the compilation, publishing and

reviewing of regulatory submissions will also benefit by attending.

Get ready for the new ERA of electronic regulatory communications!

eRegulatory Affairs 2011 / CONFERENCE ANNOUNCEMENT

2


formerly

OPENeCTD

Agenda:

Sunday, 27 February

Welcome Reception in Sponsor

Demonstration Area

Monday, 28 February (09:00 a.m. – 05:30 p.m.)

• Welcome:

Tore Bergsteiner, Chief Executive Officer, EXTEDO

• Keynote:

Steve Scribner, International Life Science Solutions:

“Where Are We Now? The Last 10 Years of eRegulatory Developments”

• EU Regulatory Landscape:

Hans van Bruggen, eCTDconsultancy: “Planning Successful

Multi-country eCTD Submissions”

• eCTD in European and Middle Eastern non-ICH Countries:

Tore Bergsteiner, EXTEDO: “An Update on the Most Recent

Developments”

• The New eCTD Module from the FDA:

Harv Martens, EXTEDO: “Considerations for Transitioning to the

New Module 1”

• eCTD Publishing:

Antoinette Azevedo, eSubmissionsSolutions.com: “Effective strategies

for creating compliant documents”

• eCTD Module 3:

Deanna Murden, ePharmaCMC, LLC: “Best Practices for Successful

Lifecycle Management of the CMC Data”

• eCTD Modules 4 and 5:

Ted Hanebach, CanReg: “Study Reports for Multi-region Submissions”

• Panel Discussion & Q&A

Tuesday, 01 March (09:00 a.m. – 04:00 p.m.)

• Customer Success Stories / Lessons Learned

(EXTEDO customers will show how they solved regulatory issues using

the EXTEDOsuite)

• Topics defined

by a group of EXTEDO customers

• EXTEDO eCTDmanger, EURS is Yours and GECCO User Group

Meeting

(wish list – open discussion, new features, roadmap) – Oliver Bojahr,

VP Global Products, EXTEDO

eRegulatory Affairs 2011 / CONFERENCE ANNOUNCEMENT

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formerly

OPENeCTD

Information

Location

Loews Portofino Bay Hotel

5601 Universal Blvd

Orlando, Florida, 32819, USA

Phone: (888) 430-4999

http://www.loewshotels.com/en/Portofino-Bay-Hotel/GroupPages/EXTEDO

Accommodation

EXTEDO has negotiated a block of rooms at the Loews Portofino Bay Hotel

at the special discounted rate of $229/night for eRA attendees.

Please reserve your room by going to:

http://www.loewshotels.com/en/Portofino-Bay-Hotel/GroupPages/EXTEDO

Registration

Please register online: www.eRA2011.org –> Registration

Contact

eRA2011 Conference

c/o EXTEDO GmbH

Einsteinstrasse 30

85521 Ottobrunn

Germany

Ellie Stone, Conference Manager

Phone: +1 508 366 4858

Cell: +1 508 439 9182

Email: stone@eracon.org

www.eRA2011.org

Fee

Early Bird (available until 21 January): USD: 995

Standard: USD 1,195

(+ VAT, including conference bag and materials, certificate,

breakfast, lunch and coffee & tea breaks, dinner on day 1)

Confirmation

Register early. Since space is limited please await the written

confirmation of your registration.

Cancellation

Your notice of cancellation must be received in writing (letter or fax)

10 working days before the conference in order to transfer your

event pass to someone else in the waiting list.

We will be pleased to transfer your registration to another member

of your company at any time. No cancellations will be accepted

after that date.

eRegulatory Affairs 2011 / CONFERENCE ANNOUNCEMENT

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