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For the 5th time on 25-26 February 2015  
*****Corinthia Grand Hotel Royal Budapest, Hungary Login to meeting scheduler demo ENG
PHARM Connect Programme & Speakers
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Programme

We are currently working on the PHARM Connect 2015 programme. For speaking opportunities please contact Katy Säurich Operations & Production Manager at TEG or calll: + 36 1 219-572.

Next year's PHARM Connect Congress will bring you an overview of the pharmaceutical and biotechnology market in the Central and Eastern European and CIS region, reflecting the recent market trends, from R&D, clinical trials, production, processing, automation, packaging, storage, distribution, logistics and supply chain management, as well as the regulatory framework.

PHARM Connect 2014 Programme

 

Centralised Model of Managing Transportation and Logistics in Europe

  • Developing centralized transportation and logistics model in Europe
  • Setup, Concept, Responsibilities, Mission and Goals
  • Quality assurance
  • Hub concept
  • Challenges related to new GDP requirement

Mr. Zvonimir Majic, Head of Quality Assurance EU Logistics, TEVA

 

   István Király, Managing Director, GlaxoSmithKline Biologicals  

Pharma Companies from Emerging Market & Asia Pacific (EMAP) – Opportunity or Threat?   
  • Introduction
  • Challenges the Pharma companies are facing
  • Emerging Market & Asia Pacific (EMAP) – Present and future trends
  • Impact on the competition landscape
  • How to respond – Do we stand a chance?

István Király, Managing Director, GlaxoSmithKline Biologicals

 

   Amer Alghabban, Director, Global Quality Assurance Auditing, Merck

 Preparing for Regulatory Inspections - The Do's, the Don’ts, and the Best Practices

  • Legal Frameworks -  reading between the lines
  • Why are you being inspected?
  • Before: Preparing for the inspection
  • During: Dos & Don’ts during the inspection
  • After: Handling inspection outcome

Amer Alghabban, Director, Global Quality Assurance Auditing, Merck

 

Attila Mile, General Manager, Xellia Pharmaceuticals

Driving Process Excellence and Productivity in Pharma Manufacturing

  • Xellia  - "New Company"
  • Challenges in Generic Pharma
  • Learning from other industries
  • Continuous improvement activities to achieve process excellence

Attila Mile, General Manager, Xellia Pharmaceuticals

 

Troels Aagaard, Xellia Pharmaceuticals

Troels Aagaard, CI Director, Xellia Pharmaceuticals

 

 

Dr. Barbara Paldus, CEO & Founder, Finesse Solutions  

Smart Factories: The Future of BioProduction 

  • Bioprocessing using SmartSystems
  • Plug-and-play SmartParts
  • Flexible SmartFactories

Dr. Barbara Paldus, CEO & Founder, Finesse Solutions

 

Matthias Birkhoff, Vice President, Marketing CHC Division, Aptar Pharma  

Unpreserved Multidose Systems – New Trends in Ophthalmic Drug Delivery

  • Challenges associated with unpreserved Eye Care medications
  • Most important demands for ophthalmic delivery systems:

- Compatibility with a range of ophthalmic medications with deviating liquid properties
- Microbiological integrity and safety
- Benefits for substances designed for chronic conditions such as glaucoma or dry eye
- Handling aspects of the system, taking patient compliance into account

 Matthias Birkhoff, Vice President, Marketing CHC Division, Aptar Pharma

 

Terry Siggins, Director Software & Services European Channels, GE Intelligent Platforms

Real-time Operational Intelligence (RtOI) – The Right Information, in the Right Hands at the Right Time

  • Put the right information into the hands of those who need it
  • Discover everything — including that which you don’t know about
  • Have reliable data with which to make better, correct, informed decisions
  • Improve efficiency by spend less time being reactive and more time being proactive
  • Achieving Operational Excellence and Delivering Results with RtOI

Terry Siggins, Director Software & Services European Channels, GE Intelligent Platforms

 

Leading Pharmaceutical Operational Excellence - Outstanding Practices & Cases

  • The St. Gallen OPEX Model
  • Current status of OPEX and future challenges
  • Case studies from leading pharmaceutical companies

Prof. Dr. Thomas Friedli, Chair of Production Management, University of St. Gallen

Terry Siggins, Director Software & Services European Channels, GE Intelligent Platforms

 

SAFETY in Pneumatic Automation

 

  • Legal Regulations
  • Risk analysis - risk assessment - risk reduction
  • Specifics for Factory- and Process-Automation
  • Safety Functions (input => logic => output)
  • Safety Hardware & Software

Thomas Schulz, Head of KAM & ISM Biotech/Pharma, FESTO

 

Vladimir Krasnikov - General Manager - RUSSIAN PHARMALICENSING GROUP

 

Entering the Russian Pharmaceutical, Biotech and Medical Markets - Best Practice 

  • 3 major segments to enter and how to find partners
  • Distinguishes between Europe and Russia 
  • Main obstacles in RA - Advice on regulatory requirements 
  • Case study presentations and best examples

Vladimir Krasnikov, General Manager, RUSSIAN PHARMALICENSING GROUP


 

Dr. Sergey Sur, Regulatory Affairs Director, Arterium

Last Changes of the Ukrainian Pharmaceutical Market: Challenges & Perspectives 

  • Main trends of the Ukrainian pharmaceutical market development during the last five years and key factors which influence on them
  • Important events of the Ukrainian pharmaceutical market during 2013 and their consequences on future developments
  • Ukraine as a leader and example for other CIS countries in the implementation of European approaches in the pharmaceutical sector (GMP and other GXPs, QbD, Clinical Trials, Pharmacovigilance, Good Regulatory Practice etc.)

Dr. Sergey Sur, Regulatory Affairs Director, Arterium  

 

Morten Munk, VP Business Development, Technology Specialist, CMC Biologics

A QbD Based Approach for Facility and Process Design, Including Single Use Systems Case Study

  • CMC Biologics' QbD based programme for facility design
  • The incremental implementation process going from a development 50 SUS bioreactors (SUB) to a full scale 2000L GMP manufacturing SUB
  • Establishing a representative down scaled laboratory model of the large scale process

Morten Munk, VP, Business Development, Technology Specialist, CMC Biologics

 

Panel Discussion: Innovative Drug Research in CEE – Regional Cooperation Needed? - Move from the World to Europe and from Europe to CEE
(
Introduction speech: Activity of the Central European Region in the EU Innovative Medicines Initiative Projects: Lessons learned from IMI1 by Prof. Ádám Vas

Prof. Ádám Vas, Research Advisor, Gedeon Richter

Prof. Vladimir Kral, Global Director Development Science & Innovation, Zentiva

        Dr. Sergey Sur, Regulatory Affairs Director, Arterium   

Dr. Zsolt Szombathelyi Global Research Director, Gedeon Richter

Prof. Ádám Vas

Research Advisor

Gedeon Richter

introduction speech

Prof. Vladimir Kral

Global Director

Development Science & Innovation

Zentiva

Dr. Sergey Sur

Regulatory Affairs Director

Arterium 


Dr. Zsolt Szombathelyi

Global Research Director

Gedeon Richter


 

Panel Discussion: Strategic Partnerships between Manufacturers and 3PLs - How to do it right and how to create the contracts accordingly

  • How to create a win-win situation for both parties?
  • How to optimise the contractual partnership?
  • Stratecig vs. short termpartnerships with a basic service level - Price negotiations and the duration of the contract
  • How to verify the performance & level of operation?
  • Importance of loyalty
 Prof. Tamas Paal, External Adviser, National Institute of Pharmacy Directorate Lenka Francišković, Head of Processes and Products Quality, Belupo

Igor Kolodiy, Chief Operation Officer, Arterium

Prof. Tamás Paál

External Adviser

National Institute of Pharmacy Directorate

Lenka Franciskovic

Head of Processes and Products Quality

Belupo

Igor Kolodiy

Chief Operation Officer

Arterium 

 

 

The congress further provides an opportunity to visit the GSK Biologicals plant in Gödöllő on February 25th at 1 pm limited to 50 delegates or the TEVA Logistic Centre on February 27th in the afternoon limited to 50 delegates and available on a first come first serve complimentary basis. The GSK Biologicals site visit will start with an introduction of the GSK Vaccines business division and the Gödöllő site, including a short movie about the activities which is followed by a site tour including a visit to the manufacturing facility. The TEVA Logistic Centre excursion will start with a 30 minutes company presentation followed by a one hour guided tour.

As an exclusive closing of the first day, guests are invited to the Cocktail Reception, sponsored by GE Intelligent Platforms and to join the unique Evening Programme at the historical Orfeum Concert Club within the Corinthia which is sponsored by PLASTRADE and BERICAP.

 

 

 

 

 

For speaking opportunities please contact:  Katy Säurich Operations & Production Manager at TEG

Tel: + 36 1 219-5725

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Sponsors
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GE Intelligent Platforms

Lead Sponsor

Aptar Pharma

Lead Packaging Sponsor

Finesse Solutions

BioPharma Technology Sponsor

Forgó, Damjanovic & Partners

Exclusive Legal Partner

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Past & Current Event Partners
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Partners
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Lead Association Partner

Hungarian Pharmaceutical Manufacturers Association

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Lead Media Partner

BBJ

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