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PHARM Connect Programme
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PHARM Connect 2013 Programme Highlights:

 

Presentation
The next Generation of OPEX: Professionalizing - Embedding - Sharpening

  • Structure to win
  • Compare to improve
  • Communicate to get engagement  

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

 

Case Study Presentation
R&D Pipeline – How to Keep it Innovative?

  • Is it worth to do R&D at all?
  • Science, market or cost driven? How to make it?
  • What is innovative?
  • How to keep it innovative?

Dr. Zsolt Szombathelyi, Research Director, Gedeon Richter

 

Case Study Presentation
The New EU Pharmacovigilance Legislations

  • Current status
  • Impact on the role of Quality Assurance & Auditing
  • Future implications 

Amer Alghabban, Director, Global Quality Assurance Auditing, Merck Serono

 

Case Study Presentation
New Trends and Future in Aseptic Processing and Barrier Technologies

  • Isolation barrier technologies principles
  • Design considerations and trends
  • Practical operational considerations
  • Advantages and disadvantages

Dr. Csaba Szőke, Global Advanced Sterile Technologies & Operational Excellence Director, TEVA

 

Presentation
The Impact of Medicines Verification Systems (EMVS)  on Today’s Pharmaceutical Supply Chain with Delegated Acts of the Falsified Medicines Directive looming just round the corner, what is the response of the supply chain stakeholders?

  • The European Stakeholder Model (ESM) – developing a cost effective solution for medicines verification in Europe
  • The role of the stakeholders and how the system works in practice
  • Securing the pharmaceutical supply chain for maximum patient safety
  • The impact of the medicines verification system on medicines distribution

Martin Fitzgerald, Deputy Director General, European Association of Pharmaceutical Full-line Wholesalers (GIRP)


Presentation
How to Best Serve your Customers? – Building a New Logistics & Pharma Service Strategy for the CEE region

  • Reviewing existing distribution strategies for CEE from a manufacturer perspective - Moving towards tailored logistics solutions
  • New distribution models in CEE - Analyzing and optimizing the logistical set-up and product flow
  • Working towards a transparent supply chain by utilizing local market knowledge & sharing market data
  • Why one size doesn’t fit all

 Zoltán Kelemen, Business Development Manager CEE Region, Phoenix

 

Case Study Presentation
Distribution and Cold Chain Management of Biologicals

  • Related GXP/GDP requirements
  • Distribution chain: critical handover points and typical problems
  • Classical small molecules vs. biological
  • Case studies and conclusions

Dr. Dávid Domonkos, General Plant Manager of the Biotech Production Plant, Gedeon Richter
András Balaskó, Manager of Department,  Materials Warehousing, Gedeon Richter
Dr. Péter Molnár, Technology Transfer Responsible, Gedeon Richter
Dr. Béla Benkő, Logistics Consultant, Gedeon Richter  


Case Study Presentation
Scale-up Approach for Fermentation Based Processes

  • Lonza Kouřim introduction, manufacturing site, history and offerings
  • General introduction of scale up – basic principles
  • Factors affected by the scale – chemical, biological and physical
  • Various scale-up approaches used for fermentation based processes
  • Lonza Kouřim general approach to scale up of fermentation processes and examples 

Miroslava Čikošová, Head of Manufacturing, Lonza Biotec s.r.o.

 

Case Study Presentation
The Future of Personalized Medicines - How Diagnostics & Biosimilars can be more Affordable?

  • How to use the newest results of cancer genome research to select the right patient population for the niche market of your drug?
  • How to prove efficacy of your biosimilar drug in a small and fast clinical trial?
  • Is the goal of companion molecular diagnostics to find the right patient to the drug or to find the right drug for the patient?

Dr. István Peták, Scientific Director & Founder, KPS Diagnostics
Dr. Richard Schwab, Medical Director, KPS DIAGNOSTICS and Organization Development & HR Director,TriGranit


Presentation
Trends in Medicated Skin Care 

  • High viscous products that may contain aggressive ingredients
  • Protection of content that is sensitive to oxygen or light
  • Drying formulation that may clog the device and reduce user acceptance
  • Prevention of content evaporation or moisture uptake
  • Reducing preservatives and avoiding metal parts in contact with product
  • Reach of all body regions and small target areas
  • Avoiding additional contact with product during application
  • Mobile life style and aging population demands, acceptance by end consumers
  • Environmental aspects

Dr. Stefan Hellbardt, VP Business Development, Consumer Healthcare, Aptar Pharma          

         

Presentation
Leverage Electronic Batch Records (EBR) to Your Advantage

  • The benefits of effectively managing EBR
  • Understanding regulations from the FDA, the EU and local organizations
  • Work Process Management – BPM for Industry
  • A software solution that supports today’s EBR needs & complies with regulations such as 21 CFR Part 11
  • The right approach for manufacturers to successfully deploy EBR

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


Case Study Presentation
Save Cost with Proportional Valve Technology for Inert Gases

  • Up to 50% lower installation cost
  • Lower life cycle cost due to simplified service and maintenance
  • Lower cost due to standardization
  • Reduced effort in automation by less IOs
  • Reduced space requirements in the plant

Thomas Schulz, Head of Industry Segment & Key-Account Management Biotech/Pharma, Festo 

 

Panel Discussion
Complexity Management in the Pharmaceutical Production Environment  – The Next Generation of OPEX

István Király, Managing Director, GSK Biologicals
Endre Kollár, Director of Production Group Germany-Italy-India, Sanofi 


Panel Discussion
Compliance Requirements - Experience with Auditing and Best practice – Are the Regulatory Requirements becoming Unreasonable?

Petr Daniel, Quality Assurance Manager, Roche s.r.o.
Dr. János Mezei, Quality Assurance Director, Sanofi
Dr. János Répási, Quality Adviser, TEVA


For the complete conference schedule, please contact the organiser at marketing@tegevents.eu
You can find the 2012's programme here: PHARM_Connect_Congress_Programme_2012.pdf

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Sponsors
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PHOENIX
Aptar Pharma
Festo
GE Intelligent Platforms
Cemelog
Glaxo Smith Kline
Pharmaprint
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