India eCTD Compilation Workshop February 17 and 18, 2011 Hotel Suba International, Mumbai, INDIA
SPEAKERS
One-day Hands-on Workshop for Novices of eCTDs
Jayaprakash Nallasamy
During this interactive workshop you will compile a two-sequence
LORENZ Life Sciences India
submission for a single country EU national procedure using
Michael Schultz LORENZ Life Sciences Germany
Jason Berning LORENZ Life Sciences Germany
LORENZ DocuBridge®, as well as repurpose the EU compilation for Switzerland. You will also examine common eCTD compilation functionalities such as: • Creating annotations and inter-document hyperlinks • eCTD publishing • eCTD validation
WHO SHOULD ATTEND This workshop is open to people from pharmaceutical, biotech, or CRO companies only.
SPACE IS LIMITED TO 20 PEOPLE PER DAY
eCTD WORKSHOP AGENDA 9:00 INTRODUCTION
12:10
9:10
CREATING A SUBMISSION
12:20 INITIAL SEQUENCE PUBLISHING
9:30
ADMINISTRATIVE DATA: COMPILING REGIONAL MODULE 1
10:00 COMPILING CONTENT WITH ONE NODE TO ONE FILE RELATIONSHIPS 10:30 BREAK 10:45 COMPILING REPEATABLE CONTENT STRUCTURES 11:15
All attendees will receive a DIA Certificate of Attendance at the conclusion of the event.
Worldwide Headquarters Drug Information Association, Inc. 800 Enterprise Road, Suite 200 Horsham, PA 19044, USA Regional Offices Basel, Switzerland Tokyo, Japan Mumbai, India Beijing, China
COMPILING CONTENT WITH ONE NODE TO MANY FILES RELATIONSHIPS
CREATING HYPERLINKS
12:30 LUNCH 1:30 BASIC ECTD VALIDATION AND CORRECTING TECHNICAL ERRORS AND WARNING 1:45 LIFECYCLE MANAGEMENT: CREATE SEQUENCE 0001 2:30 DELTA PUBLISHING AND VALIDATION 2:45 BREAK
11:30 COMPILING MODULES 4 AND 5
3:00 CLONING SUBMISSION SEQUENCE 0000 EU TO CREATE A SWISS SUBMISSION
12:00 CREATING ANNOTATIONS
3:30 CONCLUSION AND Q&A
TRAVEL AND HOTEL
MEETING CONTACTS
Attendees should make hotel reservations as early as possible to ensure availability. Single INR 4500 + Taxes
Double INR 5300 + Taxes
Hotel Suba International is located at Plot No. 211 Chakala Sahar Road, Chakala, Andheri East, Mumbai, India Contact Person: Yusuf M. Patel, Phone: +98-190-53126/ +91-22-6707-6707 Email: reservations@hotelsubainternational.com
Manoj Trivedi, Senior Consultant, Marketing & Program Development, DIA (India) Private Limited; Cell: +91-9819777493, Fax: +91-22-2859-4762, Email: Manoj.Trivedi@diaindia.org Pallavi Gokhale, Marketing Assistant, DIA (India) Private Limited; Cell: +91-9004682564; Fax: +91-22-2859-4762; Email: Pallavi.Gokhale@ diaindia.org
DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants. CANCELLATION POLICY: On or before 10 FEBRUARY 2011 Cancellations must be in writing and received by 10 February 2011. Registrants who do not cancel in writing by that date and do not attend the event will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations. If the event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants. Upon cancellation, the administrative fee that will be withheld from refund amount is:
FULL MEETING CANCELLATION (All refunds will be issued in the currency of original payment): Industry/Academia/Students = INR 2150
PLEASE CONSIDER THIS FORM AN INVOICE
eCTD Compliation Workshop Meeting I.D. # 11668 – February 17-18, 2011 – Hotel Suba International, Mumbai, INDIA
REGISTRATION FEES
Registration fee includes refreshment breaks, luncheons, and will be accepted by mail or fax. BASIC RATE
TAXES
TOTAL
Standard Membership
1768
182
INR 1950
Student Membership*
725
75
INR 800
Join DIA now to qualify to save on future events and to receive all the benefits of membership. To see all the benefits of DIA membership, visit www.diahome.org and click on Membership.
BASIC RATE
TAXES
TOTAL
6593
407
INR 7000
*A limited number of student registrations are available. A student is an undergraduate/graduate who can document enrollment in a Signature accredited, degree granting, academic program. Student registration is by fax or mail only. Please send completed registration form, copy of student identification, and payment.
TOTAL AMOUNT DUE: ____________________________
Mail or fax this form to +91-22-2859-4762. Please check the applicable category: Academia Government Industry CRO
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Completed form, along with draft/cheque made payable to DIA (India) Private Limited should be sent to:
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DIA (India) Private Limited, A-303, Wellington Business Park I Andheri-Kurla Road, Marol, Andheri (East), Mumbai 400 059 India Phone: +91-22-6765-3226 Fax: +91-22-2859-4762
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email (Required for confirmation) IF FAXING OR MAILING THIS FORM, PLEASE PROVIDE A COPY OF REGISTRANT’S BUSINESS CARD.