16th Annual Life Sciences Conference and Training

May 23, 2014 - DUBROVNIK, Croatia

BeTHEExpert 2014


Be THE Expert 2014: the life sciences industry focused conference! This year, INFOTEHNA and Qdossier proudly co-host this conference to fuse the best-in-class technical and business expertise.

The event showcases challenges within the highly regulated life science community. It serves as a forum to discuss impacts of the current and evolving regulations, directives, and position papers. These laws and interpretations have to be accommodated by adjusted processes, electronic solutions and standards. Presenters shall elaborate on best practices and future directions you need to know about.

Get together with your peers to exchange concerns and ideas, and learn how others are maintaining compliance to the present and emerging regulatory requirements.

Upon conclusion of the conference attendees should be able to:

  • Highlight global regulatory requirements and future initiatives
  • Counteract challenges for ensuring compliance to meet regional requirements
  • Know how their industry peers tackle regulatory compliance challenges (via exchanging best practices)
  • Explain organizational processes and governance to ensure integrity and quality of data, beyond a single discipline


The conference is designed for individuals involved in the development and life cycle management of pharmaceuticals, biotechnology, medical devices, and related medical products.

Agenda consists of pre-conference hands-on trainings, presentations, roundtable discussions, and networking events.

 

  

 

 

 

Convince your Manager

WHO SHOULD ATTEND?

This event has been tailored for you – professionals from the life sciences industry who work within following fields:

  •     Research and Development,
  •     Regulatory Affairs,
  •     Quality Assurance/Quality Control,
  •     IT,
  •     Representatives from regulatory agencies,


as well as everybody interested in efficient Document /Content/Process Management, and benchmark regulatory compliance solutions for life sciences industries.

WHERE WILL WE BE?

This year, we will visit one of the world’s most stunning medieval cities: Dubrovnik, the “Pearl of the Adriatic”. Situated directly on the pristine Croatian coast, it is also one of the most attractive tourist destinations in Mediterranean and UNESCO World Heritage Site. It was an important Mediterranean sea power from the 13th century onwards, and managed to preserve its beautiful Gothic, Renaissance and Baroque churches, monasteries, palaces and fountains.

The conference will take place in Valamar Lacroma Dubrovnik Hotel****+, Dubrovnik’s flagship business hotel, and the proud recipient of the prestigious 2013 World Travel Award as „Croatia’s Leading Hotel“. It is located on the tranquil Babin Kuk peninsula, surrounded by pine tree forests and soothing white pebble beaches.


We have arranged exclusive discounted hotel prices for your stay:


Valamar Lacroma Dubrovnik Hotel ****+:

  • Single room BB – €120 (per night)
  • Double room BB – €135 (per night)


Valamar Tirena Dubrovnik Hotel*** (1 min walking distance from Conference hotel):

  • Single room BB – €80 (per night)
  • Double room BB – €90 (per night)

 

As a participant of BEtheEXPERT 2014, you are entitled to extend your stay in the hotel after the conference for the same, discounted room price.

 

International Airport Dubrovnik Ćilipi (DBV) is only 20 km from the city of Dubrovnik, and offers excellent flight connections.

SPONSORS

GOLD SPONSOR
 

EMC

 

MEDIA PARTNERS
 
pharmaphorum
‘pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.’
 
PharmaVOICE
PharmaVOICE magazine provides readers with insightful and thought-provoking commentary about the challenges and trends impacting the life-sciences industry in a multiple-perspective format through articles covering a range of issues from molecule through market.
 
WorldPharma
World Pharmaceutical Frontiers is the premier information source for the world's leading pharmaceutical companies, with reliable and accurate intelligence on emerging trends and breakthrough technologies to help them make critical business decisions.
 
IPI
IPI was established to fill in the void for effective marketing and communication between all stakeholders in the Life sciences sector globally. Edited by our carefully selected editorial advisory panel, and extensive research network, IPI provides a proven supportive means of communication to the pharmaceutical, bio pharmaceutical, nutraceutical and medical devices industry the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies which will enable them to be more efficient, bring products to market faster, reduce cost and make healthcare accessible to all.

PRICE INFORMATION

 

Registration fee: 860.00 €

Formula 3+1: apply with three colleagues from your company and get 4th registration FREE OF CHARGE!

 

Package includes:

  • Full access to all sessions including pre-conference training/workshop
  • Meeting with INFOTEHNA's top consultants in Expert corner
  • Meeting with Qdossier's top consultants in Expert corner
  • Hosted luncheons and coffee breaks
  • Full entrance to all networking activities including welcoming drinks and gala dinner reception
  • Conference notes printed and on-line for future reference and knowledge sharing

 

The cost of hotel accomodation is not included in the conference fee. Participants are to arrange and pay for their own travel and accommodation. INFOTEHNA has arranged rooms at a special discounted conference rate for you.


Spouse Surcharge: 110€ (includes Welcoming Reception, Gala Dinner and Boat trip Karaka)


Excursions/Spouse Programme
Below are some of the excursions offered to the spouses by the Dubrovnik Sun Agency:

Cavtat and Konavle

Ston and Peljesac

Dubrovnik Old City

Kotor and Tivat

21 MAY: PRE-CONFERENCE DAY AGENDA

PRE-CONFERENCE TRAINING SESSIONS for SOLUTION and SYSTEM ADMINISTRATORS
11:30 - 12:00 Registration & Coffee
12:00 - 13:00

myProcessTM Tips & Tricks

Advance your skills by getting your hands on useful tips and tricks! Find out everything about new functionalities and their configuration. Improve your work efficiency!

-    New grids
-    
New actions in myProcessTM V4.5 and V4.5.1

Tomaž Kobe
INFOTEHNA Group

13:00 - 14:00 myPharma 360° Intelligence Reporting™ Suite
Create your own Intelligence Reports inside myProcessTM:
- Intelligence Reporting overview
- PowerPivot overview
- Design your own report
Miha Sedej
INFOTEHNA Group 
14:00 - 15:00 Lunch  
15:00 - 16:10 Tips & Tricks for System administrators
Unveil what every administrator should know to efficiently manage the Enterprise Document Management System:
-    System architecture and configuration
-    DQL and API
-    Object model
-    System monitoring and troubleshooting
Simon Drnovšek
INFOTEHNA Group
16:10 - 17:10

System Maintenance
Get your hands on maintenance tasks which must be carried out by administrators to provide high availability and good performance of the system.
- Monitoring the EDMS system activity
- Categorize and define maintenance operations for each component of the system

Simon Drnovšek
INFOTEHNA Group
 
19:00 Evening event: Rooftop welcome reception.
Get to know and network with your fellow peers on the Valamar Lacroma Rooftop Terrace. Revel in breathtaking views of the sunset!

 

Please note that the agenda is subject to change.

22 MAY - CONFERENCE DAY 1 AGENDA

MAIN CONFERENCE DAY
08:00 - 08:30 Registration & Coffee
08:30 - 09:30 Welcome & Introductions

Mark Evenepoel, CEO
euroscript,
Luxembourg


Elvis Paćelat, CEO
INFOTEHNA Group, Croatia

09:30 - 10:00 Solutions and global offering

Marc Haarmeier
euroscript,
Luxembourg

10:00 - 10:30 An essential update on agency requirements and expectations for Belgium including long term archiving solutions

Dr. Pieter Vankeerberghen
AFMPS,
Belgium

10:30 - 11:00 The Benefits and Challenges of eSubmissions from an Agency Perspective Mickel Hedemand
Danish Health and Medicines Authority,
Denmark
11:00 - 11:30 Coffee break  
11:30 - 12:00 Regulatory updates: Get ready for the future
RPS. HL7. ISO IDMP
Hans van Bruggen
Qdossier,
The Netherlands
12:00 - 12:30 INFOTEHNA solution strategy update Romuald Braun,
Renato Rjavec
INFOTEHNA Group, Slovenia
12:30 - 13:05 Key Performance Indicators: Three dimensions supporting decision-making in Regulatory processes
- Considering performance in three dimensions: Results, know-how and resources
- Performance and risk: two sides of the same coin
- Putting big data processing at the service of decision making
- A practical example of using available data sources to build meaningful KPIs
Dr Dimitri Stamatiadis
MAIA Consulting Sàrl,
Switzerland
13:05 - 13:40 Quality Management System as a driver for growth Miri Peleg
Dexcel Pharma, Israel
13:40 - 15:00 Lunch
15:00 - 15:35 EDMS TCO’s in Life Sciences - from mainframe to cloud and back? Romuald Braun
Uanotau Ltd.,
Switzerland
15:35 - 16:05 Selection of vendor for the eSubmission and RIM System
Bringing Regulatory Document, Process and Data Management System in-house
Stephan Rudolph
Medice, Germany
16:05 - 16:35 How to outline a future submission?

Hans van Bruggen
Qdossier,
The Netherlands

 
17:45 Gala Dinner with sunset cruize

 

THROUGHOUT THE CONFERENCE: INFOTEHNA EXPERT CORNER
Get personalized consultations from our most experienced solution experts.

 

THROUGHOUT THE CONFERENCE: Qdossier EXPERT CORNER
Detailed demo of the Qdossier content plan for transparent eCTD lifecycle and eDMS configuration Joyce van Gerven, Michiel Stam and
Hans van Bruggen

 

Please note that the agenda is subject to change.

23 MAY - CONFERENCE DAY 2 AGENDA

MORNING SESSION
09:00 - 09:30 Integral system for data integrity: Manage Regulatory Information Today to succesfully adapt to IDMP Tomorrow
EVMPD, IDMP, Managing Metadata in RIMS
Siniša Belina
INFOTEHNA Group, Croatia
09:30 - 10:00 Streamline Quality Management:  benefit from newly developed myProcess functionalities Renato Rjavec
INFOTEHNA Group, Slovenia
10:00 - 10:30 EMC Documentum for Life sciences Solution Dejan Bajić
EMC
10:30 - 11:00 Coffee break

 

STREAM 1: Regulatory Content and Processes
11:00 - 11:30 SOP Management In Teva – Rewards And Challenges Of Thinking Big Marija Uglešić
TEVA, Croatia
11:30 - 12:00 Implementation and validation of QualityExpertTM: case study

Bogdan Klimas
Jelfa (Valeant Pharmaceuticals
International), Poland

12:00 - 12:30 Challenging GCC & SFDA submissions

Gwenda Molle
Genzyme,
The Netherlands

12:30 - 13:15 Lean authoring of Module 3

Joyce van Gerven
Qdossier,
The Netherlands

Lodewijk Venhuizen 
Crucell, Switzerland

13:15 - 14:30 Lunch  

 

STREAM 2: IT solutions facilitating Regulatory Content and Processes
11:00 - 11:45 SAP integration
Discover technical backgrounds to integration of SAP and Documentum system and thus streamline enterprise processes.
Simon Drnovšek
INFOTEHNA Group, Slovenia
11:45 - 12:30 Master Data Management Goran Horak
INFOTEHNA Group, Croatia
12:30 - 13:15 Mastering Controlled Vocabularies to facilitate successful Regulatory Information Management Michiel Stam
Qdossier,
The Netherlands
13:15 - 14:30 Lunch

 

USER GROUP MEETING, Clients only
14:30 - 16:30 IPUG – INFOTEHNA Pharma User Group. Clients only.
Round table discussion provides clients with an opportunity to engage in product level discussions with INFOTEHNA product portfolio management, engineering and support personnel.

 

THROUGHOUT THE CONFERENCE: INFOTEHNA EXPERT CORNER
Get personalized consultations from our most experienced solution experts.

 

THROUGHOUT THE CONFERENCE: Qdossier EXPERT CORNER
Detailed demo of the Qdossier content plan for transparent eCTD lifecycle and eDMS configuration Joyce van Gerven, Michiel Stam and
Hans van Bruggen

 

Please note that the agenda is subject to change.

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