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Infotehna Conference with Workshop: Advanced Process and Document Management in e-Submission, QA/QC and R&D - May 19-20, 2010 (Munich, Germany)
Where: Sheraton Munich Airport Hotel, Munich, Germany
When: May 19 - 20, 2010
Infotehna’s consultants with guest speakers from Agencies and successful pharmaceutical companies will focus on areas of Quality Assurance, Quality Control and eCTD.
May 19, 2010 - Quality Assurance / Quality Control
- Change control - dangers and pitfalls/regulatory requirements, EDMS in change control,
- SOP management requirements
- Implementation of EU Variation Regulation ,
- The advantages of handling GxP documentation by means of EDMS,
- ....
May 20, 2010 - Regulatory Affairs / eCTD
- The principles of the new Variation regulation ,
- eCTD – European standard or unbinding guideline?
- Implementation of the eCTD at the agency, results of the eCTD pilot concerning validation, baseline submissions and hyperlinking,
- How to handle grouping and worksharing in eCTD? ,
- ...
Price Information:
The registration fee is €450 per conference day (VAT not included). Take advantage of discount for early booking (before April 05, 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.