The Implementation of Electronic Submissions in eCTD Format - Step 3
Wednesday 16^th March 2011

Kursaal/Hotel Allegro, Bern
09.00 - 16.30 hrs. 

Since January 2010 Swissmedic accepts Marketing Authorisation Applications in eCTD format for defined application types. As of January 2011 the last step of the introduction of eCTD at Swissmedic became effective which allows a full electronic Life Cycle Management.

During presentations and workshops the audience acquires detailed information about the submission of the additionally accepted application types. Furthermore we will discuss case studies and practical examples based on the experiences made since the introduction of eCTD at Swissmedic.

Topics

• From Step 2 to Step 3 of the eCTD introduction
• Submissions according to Paragraph 13 TPA with eCTD
• PSUR and E2E/RMP-Updates with eCTD
• Experience from a Generic Dossier
• Swissmedic's future steps
• Workshop 1 - Case Study (Swissmedic and Industry)
• Workshop 2 - Paragraph 13 TPA
• Workshop 3 - Life Cycle Management (LCM)

Target group
The Information Meeting is intended for:

• Regulatory affairs specialists, i.e. those handling authorisation documentation and submissions
• Management staff from all pharmaceutical companies intending to implement eCTD, who have already implemented it, or who are interested in obtaining information on the subject

Language
The language of the meeting will be English. All presentations will be given in English. The documentation will be provided in English, and will be published on the Swissmedic website after the event.

Cost
The cost for taking part in the event is CHF 600.00, including the meeting documents, coffee on arrival, coffee breaks, lunch as well as the participation at the workshops in the afternoon.

The invoice for the participation cost will be sent directly to the company. For technical reasons, we are not able to send personally addressed invoices. The normal payment conditions apply to settling the costs for the meeting (i.e. within 30 days).

Registration
Please complete the registration form and return it to Nicole Lüthi. The registrations will be processed in the order of their arrival. Closing date for registration: 28^th February 2011, or once all available places have been filled.

Registration is considered to be a firm commitment. If the event is fully booked, we will inform you accordingly. If you are unable to attend, the price of the seminar will not be refunded. You may, however, inform us that substitute representatives will attend.

Venue for the meeting
Hotel Allegro/Kursaal Bern
Kornhausstrasse 3
3000 Bern 25
Tel. +41 (0)31 339 55 00
Fax +41 (0)31 339 55 10
www.kursaal-bern.ch