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12th Annual INFOTEHNA Pharmaceutical Conference, June 16-18, 2010 - Primosten/Split, Croatia
Where: Hotel Zora, Primosten/Split, Croatia
When: June 16 - 18, 2010
Internationally renowned speakers from EU Agencies and eCTD consultants will focus on Post Approval Changes (Variations).
June 16, 2010
- Welcome Drink
June 17, 2010
- The principles of the new Variation Regulation,
- Implementation of EU Variation Regulation,
- How to handle grouping and worksharing in eCTD?
- Use of eCTD in DCP and MRP – Best Practice,
- Regulated Product Submissions (RPS) – perspectives and advantages,
- Implementation of the eCTD at the agency, results of the eCTD pilot concerning validation, baseline submissions and hyperlinking,
- ....
June 18, 2010
- Meet the Regulators – presentation on regulatory situation and Q&A session,
- EDMS as project management tool in Development,
- Submission management in the integral EDMS/publishing environment,
- Whats new in Infotehna's Development?
- User Group Meeting,
- ...
Price Information:
The registration fee is €450 (VAT not included). Take advantage of discount for early booking (before May 03, 2010) and discount for multiple participants from the same organization. The registration fee includes attendance at all sesions, refreshments, lunches and conference documentation. The cost of hotel accomodation is NOT included in the conference fee. Conference participants are responsible for the arrangement and payment of their own travel and accommodation.
How to Register:
Follow the link to Online Registration or fill in Registration form and fax it to +386 07 393 06 20.
For any further informations please contact Ms. Marjeta Kocjan (+386 7 393 06 00), send us an email: marjeta.kocjan@infotehna.com.