XIII. Annual INFOTEHNA Pharmaceutical Conference
May 25, 2011 - Klagenfurt, Austria
25
WED
FREE PRE-CONFERENCE WORKSHOPS
- FRIENDLY SOFTWARE SOLUTIONS FOR PHARMA INDUSTRY (Workshop for potential clients)
- SHARING OUR KNOWLEDGE (Workshop for existing users)
AGENDA/More about the workshops
12:00 - 12:30Registration
12:30 - 14:00Lunch
Sharing Our Knowledge
14:00 - 15:30
Tricks of Submission Management, Sinisa Belina, INFOTEHNA Group
- Easily maintain your dossier,
- Required attributes for successful eCTD publishing,
- Fast way to import or export your documents,
- and more.
Demonstration of Training Management Tool, Sinisa Belina, INFOTEHNA Group
- Document distribution,
- Receipt confirmation,
- Sending out of questionnaires,
- Answer validation,
- Education results tracking.
15:30 - 16:00
Coffee break
16:00 - 17:00
Pharmacovigilance Documentation in an electronic system, Sinisa Belina, INFOTEHNA Group
- Including Communication with Regulatory Authorities,
- eICSR filing process,
- MedDRA connection.
Questions, Opinions, Suggestions & Debate
Friendly Software Solutions For Pharma Industry
14:00 - 15:30
Brief Introduction to content and process management in pharmaceutical industry, Damir Stanic, INFOTEHNA Group
How to achieve efficient drug registration process with help of document management system, Miso Markov/Stefan Horneborg, INFOTEHNA Group
- EDMS based solution for the management of Regulatory Affairs operations,
- Specially designed for the management of the drug registration process,
- Built-in Technical Controls for 21 CFR Part 11 Compliance,
- CTD and eCTD publishing.
Case study - INFOTEHNA's solution for Regulatory Affairs in BELUPO helps to manage RA operations, Martin Zlatar, BELUPO
15:30 - 16:00
Coffee break
16:00 - 17:30
Managing Quality Assurance and Quality Control documentation with one solution, Damir Stanic, INFOTEHNA Group
- EDMS based solution for the management of QA/QC documentation,
- Covering: Quality Policies and guidelines, SOP management, Training management, Change control, Supplier management, CAPA management, Audits, Deviations, Incidents, Complaints, Validation, Records and many more processes.
Case study - INFOTEHNA's solution for Quality Assurance in Belupo- developed to adress special QA/QC needs, Silvio Baronic, BELUPO
Impossible made easy: handling the documentation requirements in the field of R&D, Mihajlo Ceraj Ceric, INFOTEHNA Group
- R&D Solution for: Planning, Formulation development, Pilot development, Manufacturing procedure, Process validation, Batch records, Labeling, Stability testing and more.
ALL PRESENTATIONS WILL BE IN ENGLISH LANGUAGE.
26
THU
CONFERENCE / MULTIPLE STREAMS
- REGULATORY AFFAIRS AND PHARMACOVIGILANCE (Stream 1)
- QUALITY AND DEVELOPMENT (Stream 2)
AGENDA/More about the streams
09:00 - 09:30
Registration
09:30 - 10:30
Welcome Greeting, Elvis Pacelat, INFOTEHNA Group
10:30 - 11:00
Corporate business processes integration based on EMC Documentum platform, Goran Pufler, EMC
STREAM 1: Regulatory Affairs and Pharmacovigilance
11:00 - 12:30
Regulatory situation in Ukraine. Problems and possibilities. Olga Baula, the expert on regulation of medicinal products, expert WHO
Regulatory situation in Kazakhstan, Zhumanov Bahtiyar, Ministry of Health of Kazakhstan, Control of Medical and Pharmaceutical Activities
Regulatory situation in Italia, Spain and South America, Óscar E. Mesa del Castillo Rivera, QualitecFarma
12:30 - 14:00
Lunch
14:00 - 15:00
US Submission management - Paddock case study, J.Pilate and K.Paurus, PaddockLabs
Integral document management for agencies - ALIMS case study, Gordana Pejovic, ALIMS
15:00 - 15:30
Coffee Break
15:30 - 16:30
New EU pharmacovigilance package, Paolo Biffignandi, EU VIGILANCE Ltd
EDMS integrated pharmacovigilance system, Belupo case study, Katarina Gvozdanovic
STREAM 2: Quality and Development
11:00 - 12:30
EU GMP Chapter 4 and Annex 11 -> The European Part 11, Oliver Herrman, Q-Finity
Implementation of QualityExpert - Belupo case study, Silvio Baronic, Belupo
Project organization in pharmaceutical development and required documentation, Katica Lazaric, PLIVA
12:30 - 14:00
Lunch
14:00 - 15:00
Training management in pharmaceutical company, Sanja Peterlic, SUPERA KVALITETA
Access to EDMS information via Excel reporting tool, Galina Grecenkova, GRINDEKS
15:00 - 15:30
Coffee Break
15:30 - 16:30
Selection of API suppliers for new projects, Veljko Zorzut and B. Sridhar, FARMACHEM SA
Web access to fully searchable laboratory data repository with Cassie, Velimir Gasparovic and Ivan Klaric, Calyx; Ana Skrlin, Hospira
ALL PRESENTATIONS WILL BE IN ENGLISH LANGUAGE.
27
FRI
USER GROUP MEETING
On third day, User group will take place, with information on new features and best practices.
All 3 days there will be a Hands - On Corner, where you will be able to work with our system and test its functionalities, consult our experts and get answers to any of your questions concerning the use of our solutions.
Partners
Sponsors
Media Sponsors
Media Partners
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 Management in practice
Hotel Information
Conference will take place in Lindner Seepark Hotel. We have arranged for discount prices for participants of the conference:
Single room BB = € 109 (per night)
Double room BB = € 145 (per night)
Hotel credits global frequent flyer programme miles from Miles & More.
Discount prices for participants of the conference are also available in Hotel Plattenwirt (5 min walking distance from the conference hotel):
Standard Single room BB = € 50 (per night)
Standard Twin room BB = € 90 (per night)
We will be happy to make hotel reservation for you - please contact Ms. Maja Judez (+386 7 393 06 00) or send an email to: maja.judez@infotehna.com.
Cancellation Policy
Cancellations made more then 14 days before the event will not incur cancellation charges. For cancellations made less then 14 days before the event you will be required to pay 100% of registration fee.
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. Maja Judez (+386 7 393 06 00) or send an email to:
Price Information
Conference fee = € 650 ("Early Bird" Price = € 500)
Participation on Pre-Conference day (May 25) is free of charge.
"Early Bird" price is valid for registrations prior to March 18, 2011. Take advantage of 10% discount for 4 or more 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.
This event is closed for registration.
