The round table discussion moderated by Ms. Nataša Turk, Area Director, Chamber of Commerce and Industry of Slovenia, and the author of a business guide to India, featured representatives of “Slovenian business pioneers in India”: Mr. Rudi Bric, Director and founder, PE-TRA Machines, Mr. Mihajlo Ceraj Cerić, Life Sciences Director, INFOTEHNA Group, Ms. Mirjana Dimc Perko, Chairwoman, InCon, Dr.Drago Fabijan, General Manager, Litostroj Power, and Mr. Devid Palčič, Founder and President, Robotina, while Mr. Dinesh P. Thampi, General Manager, Delivery Center Head, TATA Consultancy Services, spoke about the Indian experience with doing business in the CEE region. The speakers agreed that India, whose biggest potential are knowledgeable, clever and passionate people, has to be approached with respect to the local business culture and regulation in order to succeed and to use the land also as a springboard for other Asian countries.

A video clip by VZMT is available here.

GM Pharmaceuticals company from Tbilisi, Georgian Republic, will use INFOTEHNA's SubmissionExpert^TM solution, specially designed for the needs of Regulatory Affairs. The project is scheduled to begin in March 2012.

GM Pharmaceuticals is the sole factory in the Caucasus where the medications are produced through the all technological stages starting from the raw materials/API up to the manufacturing finished product.

Read more about SubmissionExpert^TM

Teva, the largest generic drug manufacturer in the world, will use INFOTEHNA eMPDExpert^TM to submit its entire European product portfolio information to EMA by regulatory deadline, July 2nd.

In addition to its strive to efficiency in both operations and total cost for all vendor solutions, main evaluation criteria used to evaluate SW solutions on the market were flexibility of connecting to various data sources, system features, required effort from the business and project duration.

INFOTEHNA eMPDExpert^TM, the newest member of INFOTEHNA myPharmaExpert^TM Suite, was the solution that received top ranking after weeks of detailed evaluation, including shaping very clear implementation path by our Life sciences professional services team.

Joint teams are already engaged in building the solution that will take and win the challenge of meeting XEVPRM regulatory requirements for probably the biggest product portfolio on the market.

Due to the very short implementation time of INFOTEHNA’s software solutions, we are proud to announce that Teva UK was already the first site to go live on December 19, 2011.

Marija Uglešić, Project Manager on Teva’s side, stated:

“A global SOP management solution for Teva was successfully rolled out in December 2011, with 600 new users who will be using INFOTEHNA’s solution to create and manage SOPs and related documents at this first phase. Big thanks to the INFOTEHNA team for helping us to perform all the activities on time, despite of the volume, complexity and the tight schedule - you've proven yet again to be a reliable, professional and knowledgeable partner!

We continue together with the next phases, enabling more sites and more users to use the system and we are looking forward to the new and exciting projects and new accomplishments.”

Siniša Belina, Project Manager for INFOTEHNA, said:

“We were very excited about the opportunity to work on this project with Teva team because of the challenges that a multinational, multilingual and multicultural environment presented to the implementation of a single and unified SOP Management Solution. Positive approach from all involved sides and a common goal made it easier to build a solution that will make everyone’s everyday work in SOP management easier, more reliable and in line with built-in compliance standards.

Now that the project went live, and first users have successfully started using the tool to create and manage SOP documents, I am very happy with the results achieved. I can only hope that they will enjoy using the solution as much as we have enjoyed working on this project, and that this will be just an introduction to a successful long term partnership between our companies.”

Sicor Biotech/Teva in Lithuania followed Teva UK in implementation of INFOTEHNA SOP Management Solution with 122 users on February 7, 2012, and the next in line is Teva Runcorn from UK with estimated go-live in March 2012.

INFOTEHNA eMPD

Interested in becoming a Program participant? Send us email or call +386 7 3930 600.

INFOTEHNA eMPDExpert^TM Early Adopter Program Benefits

• Early preview of the final product and chance to influence product design;
• Early preparation activities and organization of resources (before regulatory guidance and product are finalized);
• Early availability of the solution assures meeting the regulatory deadline: July 2nd, 2012;
• 30% discount on INFOTEHNA Software;
• 1 year maintenance free of charge.

As a part of the Program, customers will also receive:

• Consistent communication with INFOTEHNA;
• Priority attention by Product Management;
• A Customer Advocate;
• Early information on INFOTEHNA eMPDExpert^TM (best practices, tips and techniques);
• Access to early adopter group for information and advice exchange with other early adopters and INFOTEHNA experts.

INFOTEHNA eMPDExpert^TM as an integral part of myPharmaExpert^TM Suite assures:

• Fast and simple implementation,
• Efficient use of solution due to already trained and experienced users,
• Reduced time needed to create the list of products with necessary details (because of availability of RA documents and data for use in EVMPD process).

Read more about eMPDExpert^TM

The IT Europa European Excellence Awards recognise best practices in customer solutions by IT and software channels across Europe and are the only pan-European awards that recognise real world solutions as well as channel partnerships. 

The European IT Excellence Awards are awarded to Solution VARs and Systems Integrators recognising those who provided excellent solutions for their clients - from SMEs to major enterprises.

F.I.S. – Fabbrica Italiana Sintetici

Starting in 2012, F.I.S. will use INFOTEHNA QualityExpert^TM to effectively manage their documents in the GxP environment.  QualityExpert^TM will help F.I.S. to achieve full compliance and function on a levels that surpass regulatory requirements.

Read more about F.I.S.
Learn more about INFOTEHNA QualityExpert^TM

INFOTEHNA and Medicines and Medical Devices Agency of Serbia, ALIMS, announced the sucessful completion of the AgencyExpert^TM implementation project. Being the very first of its kind, this system for electronic document and process management solves regulatory challenges agencies across the globe are facing every day.

National health authorities hold a great responsibility for protection of public and animal health. Their capability of delivering results depends on an efficient management of complex business processes and extensive documentation. Therefore, an information system with the ability to manage vast number of records, documents and processes, is quintessential in achieving agencies' quality assurance goals.

ALIMS now has a state-of-the-art solution – AgencyExpert^TM – which successfully addresses aforementioned challenges. The fully functional system is available throughout the organization and operates on one comprehensive platform. It enables even more efficient support of an in-house and international parallel work. Furthermore, its use results in better cooperation of evaluation experts working on application evaluation. Solution also streamlines variation processes without compromising quality goals the agency has to meet. AgencyExpert^TM gives control over the entire lifecycle of documents within the agency: from capturing and creation to distribution, deployment, management, archiving and destruction. It is also worth mentioning that it significantly reduces the volume of paper documents.

INFOTEHNA’s newest addition to the company’s family of content management solutions has been awarded silver national innovation prize by Slovenian Chamber of Commerce.

About ALIMS

Medicines and Medical Devices Agency of Serbia was founded in 2004 by the Law on Medicines and Medical Devices. As defined by the latter, ALIMS' mission is to upgrade public health in Serbia through regulation of marketing and consumption of all healthcare products; all in order to make quality, efficacious, safe and available medicines and medical devices accessible to the population.

ALIMS has established its mission and vision in the Quality Policy Mission Statements, any has been granted Société Generale de Surveillance certification compliant with the Quality Management System (ISO 9001:2000) and the Environmetal Management System (ISO 14001:2002) standard requirements.

The Agency has been developing cooperation and linking up with other national regulatory authorities in European countries. Although the introduction of a completely new regulatory system in 2004 was not an easy taks, ALIMS has grown into a professional and independant regulatory body recognized as the key one in the Balkans region.

The project itself is aimed at reducing stress at the workplace and an increase of individual's commitment and identification with the company. It consists of 20 measures all directly or indirectly affecting work and life balance: e.g. an extra day of paid leave for all employees accompanying their children into kindergardens and first grade of primary schools, free sports activities for employees and their family members, financial donations at the birth of a child, etc.

The jury considered applicants' projects carefully and unanimously decided to grant the recognition to INFOTEHNA Group. Dr. Boris Dular, Director of Human Resources at Krka, and jury's president, explained: »INFOTEHNA tackles employee dedication systematically. The company not only focuses on employee, organizational culture and climate development, bonuses and awards, but also bets on high degree of integration and personal identification of each individual. INFOTEHNA's exemplary practice is a proof of a real care and concern for employee satisfaction.«

The company highly appreciates this recignition. »Satisfaction of our customers and company's success not only depend on efficiency, but also on loyalty, wellfare and satisfaction of my colleagues. With implemented measures we wish to positively impact all aforementioned categories. Human capital is most solid foundation of a long-term company growth. We are firmly aware of the importance of its permanent strenghtening,« states Elvis Paćelat, INFOTEHNA's CEO.

In his 17 plus years of rich international experience Marijo most recently served as CEO of Comminus, a Business Intelligence company, and is now “going back home”- to provide IT services and Solutions for Pharmaceutical Industry. For more than a decade he has held numerous IT executive positions in both headquarter and subsidiaries of a global Pharmaceutical company (Teva US/Barr Labs/PLIVA ), and later provided services for few other Pharma companies.  Mr. Volarevic has developed strong leadership and analytical skills he effectively couples with astute business acumen.

Mr. Pacelat, INFOTEHNA Group's CEO, is pleased to welcome our new team member:

"Marijo has worked in virtually every field of IT Services and Solutions for Pharmaceutical industry. The accumulation of his wealth of international and industry experience shall greatly contribute to our products, services and processes and will have a positive impact on executing INFOTEHNA's strategy."

TRB Chemedica, in Munich located German company focused on research, development and marketing of innovative niche products in specific therapeutic areas, chose to employ INFOTEHNA’s content management solutions for Quality Management and Regulatory Affairs.

Implementation of QualityExpert^TM, which deals with all the documentation pertinent to the challenges in GxP environment, and SubmissionExpert^TM, solution specially designed for the needs of Regulatory Affairs, is scheduled to begin in November 2011.

With their decision to use QualityExpert^TM and SubmissionExpert^TM, TRB Chemedica joined the community of more than 16.000 pharma professionals that already manage their documents and business processes with solutions from INFOTEHNA myPharmaExpert^TM Suite family.

Teva Pharmaceutical Industries Ltd. has approved INFOTEHNA’s myPharmaExpert^TM Suite in Teva Portfolio as a global solution. In next 15 months INFOTEHNA’s solution will be rolled out to thousands of users in more than 10 global sites.

Teva is the global leader in generic pharmaceuticals and a leading global supplier of active pharmaceutical ingredients (API), operating in 60 countries with 42,000 employees worldwide and the largest product portfolio in the industry.

Quality is first priority in Teva, and only the maximum achievable quality is acceptable. Same high standards apply to suppliers and partners, making the decision to utilize myPharmaExpert ^TM Suite in Teva the highest possible acknowledgment of INFOTEHNA's own dedication to excellence.

INFOTEHNA’s myPharmaExpert Suite^TM is specifically developed suite of solutions to address the challenges of enterprise content management in life science industry. Completeness of solution, richness of functionalities, flexibility, short implementation time, and attractive TCO position myPharmaExpert^TM as the top ECM solution available on the market today.

INFOTEHNA already received the golden award at the regional level, and was yesterday yet again given a recognition, this time a silver one, for the same innovation – AgencyExpert^TM, company's own solution tailored for needs of Agencies for Medicines and Medical devices accross the globe.

National innovation awards represent the highest recognition of last year's innovative achievements in the country. INFOTEHNA is very proud of its innovation team: Renato, Karmen and Jakob.

Stefan Horneborg, Regional Sales Manager of INFOTEHNA GmbH, was among the speakers at the marcus evans Conference on Document management and archiving in regulated sectors of the pharmaceutical industry. Topic of his presentation was Company wide document management solution - the road to compliance.

Other main topics of this event were:
• Technical and organizational challenges of document management in a regulated environment
• Problems and opportunities of integrated strategies for document management
• Document Management in R & D and licensing
• Document management in production

Georgian company ESABI has become INFOTEHNA Group’s new partner and representative for Georgia, Armenia and Azerbaijan. ESABI from Tbilisi is system integrator delivering wide range of hardware and software solutions to clients in various business areas. 

Together we will strive to develop the business related to INFOTEHNA’s solutions for pharmaceutical industry, as well as other areas of life science industry, like veterinary and cosmetics, with potential expansion to other areas like financial institutions, government, power industry, broadcasting, food industry and others.

130 participants, speakers, partners and sponsors from 25 countries testify to the relevancy of the topics discussed, to the global, worldwide use of INFOTEHNA's solutions for pharmaceutical industry and to the widely recognized expertise of the speakers.

First day, there were 2 workshops: Sharing our knowledge and Friendly Software Solutions for Pharmaceutical Industry, for existing and potential clients respectively. Users of INFOTEHNA solutions learned how to more effectively work with the system and how to fully exploit its features, while the perspective customers were introduced to the INFOTEHNA solutions by company experts and with help of Case Studies from real life users. In the evening, Welcome drink provided perfect opportunity to meet all the attendees in a more informal setting.

          

Second day of the conference was divided into 2 streams. In the Regulatory Affairs and Pharmacovigilance stream, the main topics were regulatory situation in various countries (Ukraine, Kazahstan, Italy, Spain, South America) and new EU pharmacovigilance package, with Case Studies of INFOTEHNA submission and pharmacovigilance solutions in various agencies and pharmaceutical companies.

Quality and Development stream offered numerous extremely interesting and useful lectures, from EU GMP Chapter 4 and Annex 11, project organization in pharmaceutical development and training management to the Selection of API suppliers for new projects.

Informal part of the day started with a pleasant boat trip across the lake to the magic Maria Loretto Castle, where the Gala dinner offered numerous occasions for expansion of business and private networks.

       

On the third and last day of the event, User Group meeting was a chance to learn about news and future plans of INFOTEHNA Group.

All 3 days, everybody had a chance to test INFOTEHNA’s solutions and consult company’s experts in the popular HANDS-ON Corner.

INFOTEHNA's team would like to express their sincere gratitude to all conference participants, speakers, partners and sponsors, who together made such a successful conference possible.
 

Links:
http://www.dnevnik.si/zaposlitve_in_kariera/aktualno/1042444633
http://www.delo.si/gospodarstvo/makromonitor/ustanovaljena-mreza-za-druzbeno-odgovornost.html
http://www.aktiv.si/novice/20110516/Dobili_smo_Mrezo_za_druzbeno_odgovornost_Slovenije/

Photographs by Janez Platiše
 

DIA’s 23rd Annual EuroMeeting in Geneva introduced important new themes such as global drug development in the real World. Discovering new synergies was an important focus and was particularly appropriate in the truly international setting of Geneva.

The EuroMeeting attracted more than 3,000 professionals from over 50 countries. It brought together professionals from the biopharmaceutical industry, contract service organisations, clinical research, regulatory agencies, health ministries, patients’ organisations and universities.

This convergence affords us the opportunity to network with professional colleagues from around the world.
  

INFOTEHNA was present in the role of a leading developer of Solutions for Quality Assurance & Quality Control.
  

On 11 February, SID bank and INFOTEHNA Group signed a loan agreement amounting 450,000 EUR. The bank is financing INFOTEHNA's latest internationalization project: after last year's expansion to Germany, we are about to penetrate North America's markets. A subsidiary named INFOTEHNA Inc. has already been formed in Chicago, Illinois.

Led by Elvis Pacelat, who has rich experience in global sales and marketing, we expect a rise in sales at 650,000 Euros in the first year, and an increase to 1,600,000 Euros in three years, in the USA.

As a well-respected and recognized technologist, Pacelat, 39, brings more than a decade and a half of leadership practice and management experience in professional services focused on the highly regulated industries.

Prior to his current responsibilities, Pacelat dealt with software development and deployment on markets across the globe. Started as a researcher and lecturer at the Faculty of Electrical Engineering and Computing in Zagreb, Croatia, he also graduated and received a Master's Degree there. Pacelat continued his career in the industry, as a software developer and later a head of development. He has been with INFOTEHNA Group for 11 years; being the technical director and the director of a branch office in Zagreb, Croatia, Pacelat successfully built and led teams of more than 30 associates.

INFOTEHNA Group, one of the European leaders in the development and delivery of highly integrated solutions for Pharmaceutical Industry, was founded by Cedomir Jakovljevic, who has now been named Chairman.

»Cedo has created a very solid base from which to grow the business. I am excited to be working for the company that has such a talented group of people in the expanding field of information technologies. My greatest responsibility is to satisfy our customers and achieve INFOTEHNA Group's overall success. I am looking very much forward to these new challenges,« said Mr. Pacelat.

More information: Sonja Jakovljević, Corporate Communications Manager

sonja.jakovljevic@infotehna.com, +386 7 3930600 or +386 51 343 101