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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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PHARM Connect 2015 Programme:


Opening Keynote Presentation: Industrial Internet Drives Productivity and Efficiency in the Life Sciences Industry

 

  • Developments and groundbreaking technologies in the Industrial Internet 
  • Maintaining real-time visibility across the supply chain
  • Industrial Internet platform requirementsDevelopments and groundbreaking technologies in the Industrial Internet 

 

Terry Siggins, European Sales Director for Manufacturing and Channel Software Businesses, GE Intelligent Platforms

 

Presentation: SmartFactories: Time and Cost Efficient Bio-Pharma from R&D to GMP

 

  • Harmonization in User Interfaces and Data Collection, Reporting from Weighing, Buffer and Media Preparation to Up- and Down-Stream Processing
  • Efficient manufacturing using Manufacturing Execution Systems (MES)
  • Finesse SmartFactory: Converting ideas into a flexible, scalable GMP bio-pharma plant wide processing and documentation solution 

Dr. Barbara Paldus, CEO & Founder, Finesse Solutions

 

Case Study Presentation: Continued Process Verification


  • From theory to practical application
  • Linking to periodic product reviews and Quality Metrics
  • Opportunities for process variations and re-validation

Dr. Joerg Gampfer, Head of Process Science and Technical Operations, Baxter


 

Case Study Presentation: Supergeneric Drug Development

  • From simple generic to supergeneric
  • Technologies used for supergenerics
  • Need for supergenerics
  • Advantages for patience
  • Specific examples

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

 

Keynote Presentation: Trends and Growth Potentials of Biosimilars - Advantage or Threat?


 

 

 

Dr. Erik Bogsch, Deputy R&D Director, Gedeon Richter


 

Case Study Presentation: Expectations, Benefits, Difficulties and Facing Reality during the Implementation of Continued Process Verification 

Dr Zsolt Nemeth GSK Vaccines
  • How to decide what to monitor – difficulties and answers
  • The monitoring SOP - Who, when, how often, the limits and actions taken
  • The statistical concepts behind and the aim
  • How to manage issues due to the lack of full process understanding?
  • Errors made (overreaction, not enough reaction, workload anticipation issues) & lessons learnt
  • Success stories: Real process improvements driven by continued process verification

Dr. Zsolt Németh, Head of Production Gödöllő Site, GSK Vaccines 

 

Presentation: Injectables-elastomers Stoppers for Injectables

 

  • Injectables-elastomers stoppers for injectables
  • Regulatory Affairs and Support
  • Innovative solutions designed for fill & finish processes

Arnaud Fournier, Business Support Manager, Aptar Stelmi

Olivier De Gall, Supply Chain Manager, Aptar Stelmi

 

Presentation: “SupraMotion – Future Concept for Pharmaceutical Production?”

  • Superconductivity in general
  • Contactless movement, handling and superconductive bearings
  • Handling through walls, in clean rooms, rotation by 360°, and more...
  • Features and benefits of SupraMotion in Pharma

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

 

Case Study Presentation: Strategies in the Development of Generic APIs

  • Originator vs. Generic views
  • Physical forms vs. Synthesis
  • Patent analysis
  • General scenarios with examples from Zentiva

Prof. Dr. Josef Hajicek, API Development Director, Zentiva 

 

Panel Discussion: Continued Process Verification

  • Best practice examples from the industry
  • Expectations from the regulatory authorities point of view

 

Dr. Zsolt Németh

Head of Production

Gödöllő Site

GSK Vaccines

 

Miroslava Čikošová

Head of

ISO Operations

Lonza Biotec  

 

Dr. Joerg Gampfer

Head of Process Science

and Technical Operations

Baxter 

 

Lenka Franciskovic

 Head of Processes

and Products Quality

Belupo

 

Panel Discussion: How to Fight against Counterfeiting - Who & how? 

  • What can Pharma companies do against counterfeiting?
  • What is the most sensitive population of society buying counterfeited drugs?
  • What is the significant source of fake drugs?

Erzsébet Ódor

Prof. Dr. Tamás Paál

External Adviser

National Institute of

Pharmacy Directorate

(GYEMSZI)


Erzsébet Ódor

Country Security

Partner

SANOFI

Dr.  Krisztina Székely

Advisor

National Board

against

Counterfeiting

Dr. Ibolya Csákó

Director

Hungarian National

Police Headquarters

Criminal Department

 

 

Project Presentations by the Award Winners of the 1st Central Eastern European Pharmaceutical Manufacturing Excellence Award

TEG The Events Group is proud to announce the call for applications for the 1st CEE Pharmaceutical Manufacturing Excellence Award.

The award has been established to honour, recognise and promote outstanding manufacturing excellence solutions in the rapidly growing region of CEE. Manufacturers as well as solution providers are welcome to apply with their most innovative projects and methods implemented in the region. Applications will be assessed by our highly renowned independent jury and the winners will have the opportunity to present their projects on CEE’s most important pharmaceutical and biotechnology manufacturing summit, PHARM Connect 2015.


Applications should be submitted by 16th of January 2015, and will be assessed by our highly renowned independent jury.

Further information click here

 

Additional Networking Activities – Site visit to the SANOFI plant in Budapest

  

The congress also provides an opportunity to visit the SANOFI plant in Budapest limited for 110 delegates only and available on a first come first serve complimentary basis on February 26th at 4:30 p.m.

 

Delegates will have the opportunity to select among the following 4 focus groups: Warehousing (max. 35 people), Production (max. 25 people), Quality Management (max. 25 people) and Chemical Development (max. 25 people). The excursion will start with a short company presentation followed by four different guided tours.

Sanofi – Ujpest Site (Chinoin)

 Welcome at significantly reshaped Ujpest facility. We hope the visitors could realize how we, as API manufacturer, progress on the adaptation of Lean culture, simplification of our processes and using this culture change to involve, empower and motivate of our 700 employees.

 Warehouse management 

CHINOIN’s warehouse management is responsible for handling of raw materials, intermediates, pharma APIs and by-products, waste materials of manufacturing. Materials could be solid or liquid form. Warehouse handles industrial gases in a significant volume.

CHINOIN specialized for receiving liquid organic solvents, raw materials by rail and handling of these materials in a closed pipeline system. This closed system is also used for transferring liquid raw materials; solvents are received in tank car.

Solid raw materials and barrels are received in our warehouse dedicated for this purposes. The new high level storage warehouse was handing over in 2011 in which the capacity was maximized by rolling racks.

The warehouse management uses Oracle electronic business solution including the usage bar code readers during its processes.

            Main data of 2014:

  • 2600 T products,
  • 10120 T raw materials,
  • 11300 T waste material

Quality Management

Quality Management is located in one building in the heart of the site. We have here several laboratories for chromatography, for classical chemistry and for microbiology and also offices for QA staff.  Our laboratories are very well equipped and modern. More than 30 HPLC and 20 GC, 1 IPC are installed in the labs, also a GC-MS helps us to identify unknown impurities. The design of the laboratories is one of the most attractive within sanofi-aventis and all above fully compliant with GMP requirements. All visitor and inspector found it very impressive.  Information techniques are also part of our life: Empower network for chromatographs, LIMS for testing and so on.

We are very proud of our results in FDA inspections, last three inspections resulted no form 483. Innovation also exists in our daily work, e.g. pseudo-fast GC technique was developed last year for quick analysis of incoming liquid raw materials.

Chemical manufacturing

Chemical production in Újpest site is a prominent organization of sanofi-aventis industrial affairs. It plays significant role in producing APIs of the leader products of the Company, for example the anti-hypertensive Aprovel (Irbesartan), the anti-thrombotic Plavix (clopidogrel) and the prostaglandine-products which are applied in wide-spectrum of indications.

The plants have gone through a spectacular development in the last 15 years. The level of technological equipment, and the process control system, the equipment for environmental protection (e.g. thermal hydrolysis, catalytic oxidation, cryotrapping, evapo condens) and the GMP-compliance fulfills the expectations of 21st century.

Yearly, our 300 colleagues provide for everyday quality of 3000 batches of 28 APIs and their intermediates.

 

 

Transfer: The bus will leave in front of the Corinthia Grand Hotel Royal Budapest on February 26th at 4:00 p.m. and will return after the plant visit at approximately 6:30 p.m.

 

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

FESTO

Process Automation Sponsor

Aptar Pharma

Lead Packaging Sponsor

Finesse Solutions

Biotechnology Sponsor

Forgó, Damjanovic & Partners

Exclusive Legal Partner

Sanofi

Exclusive Plant Excursion Partner

Codex

Exclusive Catalogue Sponsor

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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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