The PHARM Connect Congress - PHARM Connect Programme & Speakers
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For the 8th time in 2018  
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PHARM Connect Programme & Speakers
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PHARM Connect Congress 2018 will bring you an overview of the Central Eastern European market and the main trends and impacts on the pharmaceutical manufacturing & biotechnology world.

For speaking opportunities please contact

Katy Säurich

Operations & Production Manager at TEG

Email: katys@tegevents.eu | Tel: + 36 1 219-57


 PHARM CONNECT 2017 SPEAKERS

Opening Keynote Presesntation:

TERROSA - First Biosimilar Approval for Gedeon Richter  

• Key development steps for biosimilars

• Technology platforms applied

• Medical device aspects

• Clinical development programme challenges of biosimilars

• A complex IP landscape

• Market access challenges

Dr. Erik Bogsch, Head of Biotechnology R&D, Gedeon Richter

Dr. Ildikó Aradi, Head of Clinical Development of Biologics, Gedeon Richter

Dr. Katalin Fogassy, TERROSA Project Manager, Gedeon Richter

Keynote Presentation:

EU’s Falsified Medicines Directive (FMD): How to prepare now for the 2019 deadline?

• Preparing for compliance: How to protect the market?

• Global look at Big Pharma business-critical practicalities of serialisation

• GSK best practice case study and lessons learnt

Neil Lawrence

Global Serialisation Champion, Global Manufacturing and Supply, GlaxoSmithKline

Case Study Presentation:

New Equipment and Equipment Substitutes – Best Practices of Integration and Process Validation

• Considerations during tablet press substitution: how to integrate the new machine into the existing production system and how to validate operation

• How to handle differences and analogies

• Incorporation of technical improvements into the production process

Dr. János Dombovári

Director Operational Excellence Pharma Division, TEVA Pharmaceuticals Works

Presentation:

Regulatory and quality management system changes in Russian Pharma market: Recent developments and future perspective

The impact of main regulatory requirements on drugs turnover

•  Local clinical trials,Russian GMP inspections

•  State quality control system

•  Price regulation

Eurasian Union pharmaceutical market. What exactly was introduced and what are the expectations?

Ekaterina Tvorogova

Regulatory Affairs Manager, Egis Pharmaceuticals, Representation in Russia

Case Study Presentation:

Challenges in meeting Good practices for data management and integrity in regulated GMP environments guidance

• General requirements related to data integrity

• Main FDA and EU inspections observations in scope of data management and integrity

• Data management and Integrity program for pharmaceutical company

Dr. Piotr Lipinski

Quality Systems Manager/QP, Novartis Technical Operations - Platform Solids Europe, Lek / Novartis

Presentation:

Concepts to improve the productivity of drug innovation

• Trends in performance of drug innovation, an overview

• Limitations of productivity

• Some principles for (more) effective preclinical research

• The possible contributions of University to drug discovery

• Case studies

Professor Péter Mátyus

Director of the Drug Discovery and Safety Centre and CEO of the Bionics Innovation Center, Semmelweis University Budapest

Presentation:

„Spread the Word”

• How are the fake drugs distributed?

• Who buys on the internet?

• How to inform the customers about the risk?

• Program for generation Z

• What is their reflection?

Dr. Lívia Ilku 

Director

Hungarian Pharmaceutical Manufacturers Association (MAGYOSZ)

 

Erzsébet Ódor

 Country Security Partner, SANOFI

Head of the Hungarian Pharmaceutical Manufacturers Association (MAGYOSZ) Environment Subcommittee

Case Study Presentation:

Industry 4.0 and Single Use Technology in BioPharma

• The 4th Industrial Revolution

• Improving Competitiveness

• Impact for BioPharma

• Continuous Manufacturing

• Examples of implemented Smart Factories

Dirk Tillich

VP Global Sales, Core Business, Finesse Solutions

Case Study Presentation:

Discover Pall’s full mAb Purification Platform

The presentation illustrates recent evolutions in Bioprocessing and describes in detail all potential opportunities for a process platform run in continuous mode. The content rounds up with an overview of selected Pall products and gives useful application details in Downstream Processing.

Adriane Raninger

Bio-Purification Process Specialist CEE, Pall Life Sciences

Case Study Presentation:

Efficiency increase for single-use cell removal (Midstream) using filter aid and continuous process design

• Increasing cell removal efficiency

• Continuous process

• Cost effective process

Ralph Daumke

Market Manager Biologics, FILTROX

  PANEL DISCUSSION DAY 1

 EU’s Falsified Medicines Directive (FMD): How to protect the market?

Grzegorz Brzoskowski

Security Director CEE / Baltic, SANOFI

Réka Balogh

Serialization Project Coordinator, QA Expert, TQM, Gedeon Richter

Leader of the Hungarian Pharmaceutical Manufacturers Association(MAGYOSZ) Safety Feature Committee

Neil Lawrence

Global serialization Champion,Global Manufacturing and Supply, GlaxoSmithKline

 

 

 

 

 PANEL DISCUSSION DAY 2

 Regulatory and quality management system changes in Russian & Ukrainian Pharma market

 Introductory speech by Dr. Sergii Sur, Regulatory Affairs Director, Arterium Corporation

Dr. Herta Pálfi Goóts

Director, Regulatory Affairs, Gedeon Richter

Head of the Hungarian Pharmaceutical Manufacturers Association (MAGYOSZ) Regulatory Affairs Committee

Dr. Sergii Sur

Regulatory Affairs Director, Arterium Corporation

Ekaterina Tvorogova

Drug Regulatory Affairs Manager, EGIS Pharmaceuticals, Representation in Russia

 PROJECT PRESENTATIONS BY THE AWARD WINNERS
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 were welcome to apply with their most innovative projects and methods implemented in the region. The winners had the opportunity to present their projects at PHARM Connect 2017.

Presentation of the Award Winner in the Solution Provider Category

In 2017 at PHARM Connect Blulog won the 3rd CEE Pharmaceutical Manufacturing Excellence Award in the solution provider category by developing an innovative solution for temperature and humidity monitoring and produced NFC connected boxes to assure the wireless and precise temperature and humidity monitoring during drug transportation.

Jeremy Laurens, Sales and Marketing Director, Blulog

 

Presentation of the Award Winner in the Manufacturer Category

In 2017 at PHARM Connect Meditop Pharmaceutical Ltd. won the 3rd CEE Pharmaceutical Manufacturing Excellence Award in the manufacturer category by developing an innovative approach to improve film coating efficiency with developing and applying of a continuous film coater.

Dr. János Bajdik, Head of Pharmaceutical Laboratory, Meditop

 


 ADDITIONAL ACTIVITIES
 

PRE-EVENT PROGRAMME | 21st February 2017

Site visit to the GlaxoSmithKline Biologicals plant

The congress provides the opportunity to visit GlaxoSmithKline Biologicals in Gödöllő; this is limited for 50 delegates only and available on a complimentary, first-come, first-served basis at 13:00 on 21st February.

GlaxoSmithKline Biologicals Kft. is located in Gödöllő and is part of the GlaxoSmithKline Vaccines business branch. At the Gödöllő site GSK is producing, testing and releasing Tetanus and Diphtheria bulk antigens for shipment to other GSK Vaccines sites. About 220 people are involved in the manufacturing of antigens used in vaccines such as Synflorix™, Menitorix™, Hiberix™, and MenHibrix™. The Gödöllő site contributes 12% to the annual turnover of GSK Vaccines.

The visit of the site will provide an opportunity to get more information about the activities of the Gödöllő site, the vaccine manufacturing process and the manufacturing facility of the biotechnology site. The 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.

Delegates can select among the following three focus groups:

• Group A: production corridor, Biochemistry lab and warehouse

• Group B: warehouse, production corridor, Microbiology lab

• Group C: Microbiology lab, warehouse and production corridor

As for the outfit, jeans and comfortable shoes are required. Helmet is needed in warehouse, gowning (coat) in Biochemistry lab, gowning (coat) and shoe cover are needed in the Micobiology lab and will be provided before the visit.

TRANSFER: The bus will leave in front of the Corinthia Grand Hotel Royal on February 21st at 12:00 p.m. and will return after the visit at approximately 5:00 p.m.

POST-EVENT PROGRAMME | 23rd February 2017

Site visit to the Research Centre for Natural Sciences at the Hungarian Academy of Science (MTA TTK)

The congress provides the opportunity to visit the Research Centre for Natural Sciences at the Hungarian Academy of Science (MTA TTK) in Budapest; this is limited for 60 delegates only and available on a complimentary, first-come, first-served basis at 17:00 on 23rd February. The MTA Research Centre for Natural Sciences carries out multidisciplinary research in natural sciences.

Priorities are given to the following disciplines:

• Organic chemistry

• Materials- and environmental chemistry

• Molecular and cellular life sciences

• Cognitive neuroscience and psychology

The visit will start with a short, introductory presentation about the MTA TTK. Afterwards, the delegates will have the opportunity to choose a tour to the four research institutes:

Organic chemistry

Developing novel types of reaction, the synthesis of new ring frames and compounds in the field of organic small- and supramolecular molecules, determination of chemical structure and interpretation of experimental processes by instrumental techniques and theoretical calculations.

Materials- and environmental chemistry

Research of discovery and experimental development in some key areas of materials- and environmental science, with special emphasis on chemical aspects thereof. Exploratory research in the field of nanoscale functional materials and application of the results in integrated nano/micro systems.

Enzymology

Researchers at the Institute of Enzymology investigate the structure of proteins and how they function – at the level of molecules through to complex organisms. They make use of the latest biochemical, imaging and genetic engineering methods to reveal the structure of proteins, their properties and the biological functions enzymes perform in the human body. Further important areas of research are signal processing and transmission, the regulation of protein breakdown and how cancer evolves. The researchers also want to find out what the actual protein composition of the cell looks like and how complete biological systems function. Target-based drug development.

Cognitive neuroscience and psychology

Research of discovery and applications in experimental psychology, human-, developmental and comparative psychophysiology, social development psychology, social psychology and cultural psychology.

TRANSFER: The bus will leave in front of the CORINTHIA Grand Hotel Royal on February 23rd at 4:00 p.m. and will return after the visit at approximately 8:00 p.m.


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Sponsors
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Pall Life Sciences
Finesse Solutions
FILOTROX
Bird & Bird

Exclusive Legal Partner

GSK Vaccines

Exclusive Excursion Partner

MTA TTK

Exclusive Excursion Partner

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Sample list of sponsors
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Partners
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Lead Association Partner

Hungarian Pharmaceutical Manufacturers Association

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Exclusive Hungarian Media Partner

MarketingPirula- PirulaTrend

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