10th Infotehna Annual Pharmaceutical Conference and Pharmaceutical User Group Meeting
Where: Bluesun Hotel Elaphosa Bol on Brač Island, Croatia
When: 21 – 23 May 2008
Agenda Registration form Hotel booking form
Following the success of our previous conferences we are glad to announce the 10th Infotehna Annual Pharma Conference and Pharma User Group Meeting which will be held in Bol on beautifull island of Brač, 21 – 23 May 2008.
21 May 2008
PRE-CONFERENCE WORKSHOP
Workshop for participants for whom this will be the first exposure to Electronic Document Management System.
As the result of the workshop, participants will gain the understanding of regulatory requirements for Electronic Document Management System (EDMS) in pharmaceutical environment as well as the capabilities of Infotehna solutions to fulfil those requirements.
Focus will be on:
- Introduction to electronic document management and electronic submission management in generic pharmaceutical industry
- Electronic submissions and eCTD
- Case Study: Practical demonstration of electronic document management and electronic submission management
How will you benefit:
- Individualized approach
- Possibility to organize a meeting with our existing customers, exchange of experiences with Infotehna customers who succesfully use one or more of Infotehna solutions. Our team of experts (from pharmaceutical and IT field) will be available to find and explain a tailored solution for your company needs.
Who should attend:
This event will target Professionals from the Pharmaceutical industry such as Departmental Heads, Directors, Managers and Specialists in the fields of:
- Regulatory Affairs
- Quality Assurance /Quality Control
- Development Research and
- Marketing
- Production
- Maintenance
- IT…who until now were not exposed to Electronic Document/Content Management Systems
22 May 2008
10th INFOTEHNA ANNUAL PHARMACEUTICAL CONFERENCE
Two parallel streams will be organised:
- eCTDStream
- Quality Stream
This year we decided to organise Quality Stream in addition to usual Regulatory Stream. The reasons for this were several:
- The quality paradigm is changing from direct control to risk analysis, what will have profound effect on the way of doing business in generic companies.
- There is a strong emphasis on record management, especially in US, what has to be taken in consideration when designing electronic archiving.
- Experience in using EDMS in quality field was gained by several of our customers, who will be happy to share it with other potential users.
- Quite a few functionalities were added to Infotehna QUASSAR (QualityExpert is a new name for it), which we will be proud to present.
For the detailed information see attached agenda
How will you benefit:
- Delegates will gain the Regulator's perspective to ensure that electronic submissions stay in line with the current trends.
- In Quality stream, a renown expert will bring you up to date with the recent approaches to quality management, and experts from several generic companies will share with you their experiences how to apply an EDMS solution in Quality field.
Who should attend:
This event will target Professionals from the Pharmaceutical industry such as Senior Executives, Departmental Heads, Directors, Managers and Specialists in the fields of:
- Regulatory Affairs
- Research and Development
- Quality Assurance/Quality Control
- Representatives from regulatory agencies as well as everybody interested in Document/Content practice
Topics presented and discussed by industry experts:
- Current ICH eCTD Specification
- Transition from paper to electronic – Status in the Netherlands
- Electronic Submissions in Hungary
- eCTD and NeES – MHRA point of view
- eCTD Lifecycle Management
- eCTD in MRP&DCP
- EU Telematics System
- Implementation of EDMS in JAZMP – Case Study
- Documentation in GMP Environment (requirements, rules, document management, 21 CFR 11, EU GMP)
- Records Management: Strategies&Opportunities For Success
- Risk Management as a new QA Approach
- SOP Management
- IT Systems Change Control
- Audit Management (internal and external)
- Change Management
- OOS and Incident Management
- etc
23 May 2008
INFOTEHNA PHARMACEUTICAL USER GROUP MEETING (IPUG)
This meeting will be organised in order to inform existing users of Infotehna solutions on new developments and possibilities the solution is offering.
This year’s focus will be on:
- What’s new: Updates and New Functionalities of New Infotehna Products
- Change Management, Submission management, eCTD publishing, PDF Publishing, LoD & Variation management, Update submission, Hyperlinking - screen cams and live demo
Who should attend:
- Users of Infotehna Solutions
- Great opportunity for new, potential customers of Infotehna Solutions for exchange of experiences
NETWORKING EVENTS
21 May 2008
Welcome Cocktail for all participans
22 May 2008
Animation program and social event
WAYS TO REGISTER
Please fill in Registration form and fax it to: +386 (0)7 393 06 20 or e-mail to events@infotehna.com or call Mrs. Alenka Licen on +386 (0)7 393 06 00.
The official carrier Croatia Airlines has arranged special airfares with the “10th Infotehna Annual Pharmaceutical Conference and Pharmaceutical User Group Meeting.
Croatia Airlines will grant special discounts on international flights on certain airfares for the participants and 1 accompanying person according to the following details:
C = 20% discount
D = 10% discount
Y, B = 15% discount
M, H, Q = 10 % discount
This discount is applicable for Croatia Airlines international flights only, on tickets purchased at Croatia Airlines offices.
To obtain this discount, Croatia Airlines discount voucher and a confirmed registration form or other written proof of participation must be presented at the time of purchase.
If you would like to take advantage of this special offer, please contact the nearest Croatia Airlines office.
The list of Croatia Airlines offices, as well as the discount voucher and all information concerning granted discount can be found at www.croatiaairlines.com – at your service – official carrier.
HOW TO TRAVEL TO BRAČ
Information for participants, coming to Split by their own car:
There is a time-table of car ferry from Split to Supetar, from where there is about 35 km drive to Bol for 21 May 2008: 5.15 a.m., 6.15 a.m., 9.00 a.m., 11.00 a.m., 12.45 p.m., 2.15 p.m., 4.30 p.m., 6.00 p.m., 9.00 p.m., 11.59 p.m.
Time-table of car ferry from Supetar to Split, 23 May 2008: 5.00 a.m., 6.30 a.m., 7.45 a.m., 10.30 a.m., 12.30 p.m., 2.30 p.m., 3.30 p.m., 6.00 p.m., 7.30 p.m, 10.45 p.m.
It takes 50 minutes to reach Supetar from Split, price for the ferry is 25 HRK per person, for the car 117 HRK.
There is a free parking space provided at our conference hotel Elaphusa.
Information for participants, coming to Split by air:
Participants who will arrive to Split Airport are kindly requested to take a taxi to our meeting point in Split: F CAFÉ, Obala Lazareta 3, Split.
F-caffe is situated in the center of town, near by Bus Terminal, Railroad Terminal and see port (katamaran station for Bol is next to our caffe bar and ferry to Supetar is 5 min. walking distance). It is ideal place to enjoy professional service, wonderful ambiance and view ancient vales of Diocletian's Palace. Capacity of our caffe bar is cca. 400 persons, ideal for group of tourists or meeting point. See location of F-caffe here or check www.f-caffe.com.
Infotehna Representative will be at F-caffe on 21 May from 12 a.m. until 6 p.m. and will be available to organize your transportation to the conference hotel in Bol. Please check time-table for car ferries in the previous chapter.
Once daily there is a Catamaran, leaving Split harbour at 4 p.m. and going directly to Bol (only for passengers, without a car), price per person is 22 HRK. On 23 May the same catamaran leaves Bol at 6.20 a.m. directly to Split. In case you need any help please call mobile phone no. of our representative, Mrs. Jakovljevic, at F-caffe is +386 51 343101 or mobile phone of Mrs. Licen, who will be waiting for you in conference hotel in Bol, +385 41 611144.
For further information regarding this or other Infotehna events, please contact Alenka Licen alenka.licen@infotehna.com T: +386 7 393 06 00 F: +386 7 393 06 20
GENERAL SPONSORS:
SPONSORS:
Genericsweb
Genericsweb Pipeline - Patent Intelligence
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