PROGRAMME & SPEAKERS

PHARM Connect Congress each year brings you an overview of the Central Eastern European trends and impacts on the pharmaceutical manufacturing & biotechnology world.

TOPICS & SPEAKERS IN 2019


POST EVENT INFORMATION
CHAIRPERSON

 

Biotech and R&D

Dr. András Ballagi
Dr. András Ballagi

Chief Technology Officer


Dr. András Ballagi

Dr. András Ballagi

Chief Technology Officer, Diagon

Dr. Ballagi moved to Sweden shortly after completing his degree in Bioengineering. There he worked in the field of the diagnosis and molecular evolution of veterinary viruses at the Swedish Veterinary Institute. He received his PhD for his research on application of PCR for virus detection and analysis of viral outbreaks. Later he moved on to fermentation technology of recombinant microorganisms at the University of Uppsala. After almost 20 years in Sweden he returned to Hungary in 2006 and joined Gedeon Richter Plc. to lead the technology development for biosimilar medicine production using bacteria (E.coli) as well as mammalian (CHO) cells.

In 2014 he formed the Biotechnology unit in the newly established Pharmatech Model Laboratory (PML) at the Budapest University of Technology and Economics, where he also holds an Honorary Professorship. Since November 2016 he has been responsible for the recombinant protein development and production of human diagnostic at the Diagon Ltd, Budapest.

CHAIRPERSON

 

Industrial

Prof. Dr. Romána Zelkó
Prof. Dr. Romána Zelkó

Dean Faculty of Pharmacy


Prof. Dr. Romána Zelkó

Dr. Romána Zelkó

Dean Faculty of Pharmacy, Semmelweis University

Romána Zelkó Ph.D., D.Sc. has her expertise in formulation and stability tracking of polymer-based drug delivery systems including various micro- and nanofibrous systems. Her research work focuses on different synthetic and natural polymeric delivery systems, physical ageing of polymers, microstructural characterization of dosage forms associated with their functionality-related characteristics. She is the author of 190 journal full papers and 5 patents and expert works. From 1991 she is employed by the Faculty of Pharmacy of the Semmelweis University.

She advanced her studies in the pharmaceutical technology at the Ghent University, Belgium. She has been successfully passing the achievements of her scientific research work on to her students at various Ph.D. studies. She has held a variety of functions. She has served as a Vice-Dean (2003-2009) and from 2013 as the Dean of the Faculty of Pharmacy of the Semmelweis University.

CHAIRPERSON

 

Technological

Prof. Dr. Stane Srčič
Prof. Dr. Stane Srčič

Head of Pharmaceutical Technology Department


Prof. Dr. Stane Srčič

Prof. Dr. Stane Srčič

Head of Pharmaceutical Technology Department, Faculty of Pharmacy, University of Ljubljana

Dr. Stane Srčič is a Professor for Pharmaceutical Technology at the Faculty of Pharmacy, University of Ljubljana, Slovenia. His expertise is focused on solid oral dosage forms development and manufacturing and includes pre-formulation and formulation, new manufacturing methods and customized equipment. After PhD he spent as post doc at the University of Regensburg, and was/is acting as a visiting Professor at the University of Liverpool, Szeged and Sarajevo.

He served for more than 10 years as an expert from Slovenia on EMA (London) in the Committee for drugs in veterinary medicines and was responsible for quality parts of the dossiers.

He published more than 150 papers and is holder of numerous patents and patents applications in EU, US, Russian Federation and India. He is strongly connected with domestic and foreign pharmaceutical industry and was leading a lot of different academia-industry projects.

His international collaboration on the education and research areas has been recognized and awarded with the honorary doctorate from the University of Szeged (Hungary).

CHAIRPERSON

 

Regulatory

Assoc. Prof. Dr. Ildikó Csóka
Assoc. Prof. Dr. Ildikó Csóka

Director of the Institute of Pharmaceutical Technology and Regulatory Affairs


Assoc. Prof. Dr. Ildikó Csóka

Prof. Dr. Ildikó Csóka

Director of the Institute of Pharmaceutical Technology and Regulatory Affairs, Faculty of Pharmacy, University of Szeged 

Ildikó works at University of Szeged since 1990, after graduating as a pharmacist at University of Szeged.

Between 1990 – 2003 she worked as an assistant lecturer and later as an Assistant Professor at the Department of Pharmaceutical Technology. Experiences and competencies: dermal and transdermal dosage form design, the teaching of drug manufacturing processes, process development. Based on her research on colloidal drug delivery systems, she got the PhD title in the year 1997. Between 2004 – 2016, she worked at the Institute of Drug Regulatory Affairs; since 2008 as the Head of the Institute. She got the Dr. habil. degree and became Assoc. Professor in the year 2007.

Paralelly with these activities she worked as Educational Vice-Dean of the Faculty of Pharmacy between 2009-2012; was the Head of the „Office for Postgraduate Studies” at Faculty of Pharmacy (2010-2012), and also for two years (2010-2011) she was the Head of Department of Clinical Pharmacy.

Prof. Ildikó Csóka has been working for the University Management since 2012; presently as the General-Director for Strategy. Based on the close cooperation between the Department of Pharmaceutical Technology and Institute of Drug Regulatory Affairs, in 2016 she founded a new Institute dealing with a „Quality by Design” based dosage form development and manufacturing process optimisation together with 50 colleagues in teaching and research, and presently she is the Head of this Institute. She has postgraduate specialisations in Pharmaceutical Technology, Health Care and Pharmacy Management and Quality Assurance.

Her research field covers: regulatory pharmacy based dosage form design in the field of nano and biotechnology, developments in alternative drug delivery routes; co-creation and knowledge transfer in healthcare and pharmaceutical R & D; patient expectations, satisfaction and adherence evaluations in connection with the quality of life measurements.

KEYNOTE PRESENTATION

Personalized Medicines - Current Impacts on the Pharma Industry and Future Scientific Possibilities

Dr György Németh
Dr György Németh

Chief Medical Officer at Gedeon Richter, President of Hungarian Society of Personalized Medicine


Dr György Németh

Personalized Medicines - Current Impacts on the Pharma Industry and Future Scientific Possibilities


Personalized medicine is the key factor of today’s changes in healthcare. The uptake of PM has been initiated by different reasons. One of them is a medical pressure: the improvement of benefit/risk ratio, the other is an economic pressure: the improvement of price/value ratio. New technologies, the genomic and digital medicine offer/provide widening possibilities for the above listed.

Translational and personalized medicine take into consideration all the three aspects. Its uptake was evolutional, recently, however, it has become disruptive. Health-related decision making has moved from a budget-approach towards a cost-efficient approach. On a scientific level the more precise understanding of the pathophysiology of diseases initiate the spread of target therapy rather than the therapeutic reductionism. The regulatory background of all these shifts from a passive to an active regulation. With the use of diagnostic tools predicting safety and efficacy there is a possibility to select the adequate medicine and to monitor the illness/disease. We should not underestimate the methodological challenges and the previously unrecognized ethical issues. The lecture concentrates on the events and trends of the recent past from the viewpoint of pharmacology considering the possible dangers and the future potentials derived from our present knowledge/experience.


Dr György Németh is the Chief Medical Officer at Gedeon Richter and also the President of Hungarian Society of Personalized Medicine

CASE STUDY PRESENTATION

Industrial Scale Precision Separation by Centrifugal Partition Chromatography

Sándor Polányi
Sándor Polányi

CEO


Sándor Polányi

Industrial Scale Precision Separation by Centrifugal Partition Chromatography


RotaChrom Technologies has developed the world's first industrial scale Centrifugal Partition Chromatographic (iCPC) technology platform.

The company's instruments have revolutionized the purification industry by providing cost effective commercial scale chromatography solutions to customers all over the world.


Sándor Polányi, CEO of RotaChrom 

CASE STUDY PRESENTATION

End-to-End Solutions from Pall Biotech – An Innovative Approach to Design Bioprocesses for Optimal Performance

Dr Christian Hetzel
Dr Christian Hetzel

Integrated Solutions Manager


Dr Christian Hetzel

End-to-End Solutions from Pall Biotech – An Innovative Approach to Design Bioprocesses for Optimal Performance


• End-to-End Biotech Solutions

• Full process capability

• Traditional (Stainless Steel), Single Use or Continuous processing

• Optimized Bioprocess Design


Dr Christian Hetzel is Biotech Integrated Solutions Manager at PALL Biotech

CASE STUDY PRESENTATION

Building a New Pharmaceutical Plant

Tomislav Đuranek
Tomislav Đuranek

Director of Maintenance & Energetics


Tomislav Đuranek

Building a New Pharmaceutical Plant


• Planning and Preparation of the Project

• Design Phase

• Execution Phase


Tomislav Đuranek is the Director of Maintenance & Energetics at Belupo Pharmaceuticals

CASE STUDY PRESENTATION

Data Integrity - How to Interpret the Guidelines into Procedures and to Reduce “Grey Zones”

Dr Piotr Lipiński
Dr Piotr Lipiński

Global Quality Auditor, Audit & Compliance, Europe II


Dr Piotr Lipiński

Data Integrity - How to Interpret the Guidelines into Procedures and to Reduce “Grey Zones”


• Data integrity guidelines

• Data integrity aspects in paper records

• Audit trails

• Data backup and restore

• Data Integrity in Quality Control Laboratory

• Data integrity self inspections


Dr Piotr Lipiński is the Global Quality Auditor for Europe II at Novartis Technical Operations Quality

CASE STUDY PRESENTATION

Introduction of Lean Management Tools & Principles in the Biotech Pharma Industry

Dr János Dombovári
Dr János Dombovári

Project Manager, Biotechnology Division


Dr János Dombovári

Introduction of Lean Management Tools & Principles in the Biotech Pharma Industry


It is always a challenge to introduce and implement the phylosophy of lean in the highly regulated pharmaceutical industry. The lecture will highlight some of the major questions of this introduction process in our biotech pharma facility:

• How to harmonize the lean phylosophy and the GMP quality approach of the pharma production?

• How to build up a lean introduction program in a biotech facility?

• How to use lean tools (5S, Kanban, visual management, process confirmation) on the shop floor?

• What are the benefits of using systematic problem solving as a quality tool?

• How idea management can influence the lean culture of a pharma plant?


Dr János Dombovári is the Project Manager of the Biotechnology Division at Gedeon Richter

KEYNOTE PRESENTATION

Science Fiction in Healthcare

Dr Bertalan Mesko, PhD
Dr Bertalan Mesko, PhD

Director of The Medical Futurist Institute


Dr Bertalan Mesko, PhD

Science Fiction in Healthcare


Science fiction that helps prepare for the future sneaked into our lives except the most important field: healthcare. The cultural transformation we call digital health is making it happen through the use of advanced technologies.

Of all the trends and technologies, artificial intelligence is far the most promising and dangerous technology that requires attention today as it, with patient design, transforms how pharmaceutical companies are developing their products, approaching their consumers and planning ahead.


Dr. Bertalan Mesko, PhD is The Medical Futurist and the Director of The Medical Futurist Institute analyzing how science fiction technologies can become reality in medicine and healthcare. As a geek physician with a PhD in genomics, he is also an Amazon Top 100 author. He is also a Private Professor at Semmelweis Medical School, Budapest, Hungary.

CASE STUDY PRESENTATION

Formulation Possibilities for Delivery of Biopharmaceuticals

Dr Tamás Sovány
Dr Tamás Sovány

Assistant Professor at the Institute of Pharmaceutical Technology and Regulatory Affairs


Dr Tamás Sovány

Formulation Possibilities for Delivery of Biopharmaceuticals  


• Introduction of FIP perspective on the formulation and development of biopharmaceuticals

• Grouping of Biopharmaceuticals Devices for parenteral and transdermal protein delivery

• Possibilities in oral protein delivery

• Challenges in protein processing and protein absorption

• Possibilities in nasal and pulmonar protein delivery

• Challenges and delivery devices


Dr Tamás Sovány is Assistant Professor at the Institute of Pharmaceutical Technology and Regulatory Affairs, Faculty of Pharmacy at University of Szeged 

CASE STUDY PRESENTATION

Data Integrity Assurance & Investigations of Data

Izabela Majić
Izabela Majić

Head of Inspectorate


Izabela Majić

Data Integrity Assurance & Investigations of Data


• Data Integrity -- Risk-Based Approach to Preventing & Detecting

• Data Life Cycle Design and Controls

• Validation for Data Integrity

• CGXP Requirements for Data Integrity, including Current Health Authority Data Integrity Guidances

• Techniques to Identify and Investigate Aberrant Data Patterns

• Reviewing electronic data and metadata -- such as audit trails

• Case study of hands-on live system audit to detect data integrity issues


Izabela Majić is the Head of Inspectorate at the Agency for Medicinal Products and Medical Devices of Croatia, HALMED

CASE STUDY PRESENTATION

Data Integrity Assurance & Investigations of Data

Ivan Bašic, PhD
Ivan Bašic, PhD

GMP Inspector Expert


Ivan Bašic, PhD

Data Integrity Assurance & Investigations of Data


• Data Integrity -- Risk-Based Approach to Preventing & Detecting

• Data Life Cycle Design and Controls

• Validation for Data Integrity

• CGXP Requirements for Data Integrity, including Current Health Authority Data Integrity Guidances

• Techniques to Identify and Investigate Aberrant Data Patterns

• Reviewing electronic data and metadata -- such as audit trails

• Case study of hands-on live system audit to detect data integrity issues


Ivan Bašic is the GMP Inspector Expert of the Agency for Medicinal Products and Medical Devices of Croatia, HALMED

CASE STUDY PRESENTATION

Hot-Melt Extrusion (HME): A Cost Effective Approach Leading to Enhancement of Bioavailability

Dr Devendra Ridhurkar
Dr Devendra Ridhurkar

Expert Scientist Modified Release Formulations


Dr Devendra Ridhurkar

Hot-Melt Extrusion (HME): A Cost Effective Approach Leading to Enhancement of Bioavailability


• Hot melt extrusion (HME): Introduction, A single solution to various problems

• Screening of polymer for HME

• Common plasticizers used  for HME

• HME process and equipment, Twin-screw extruder - screw elements

• Evaluation of HME formulations

• Advantages and disadvantages of HME


Dr Devendra Ridhurkar in an Expert Scientist of Modified Release Formulations at Neurax Pharmaceuticals

PRESENTATION

WINNING PROJECT OF THE MANUFACTURER & SOLUTION PROVIDER CATEGORY

Apply for the 5th Central Eastern European Pharmaceutical Manufacturing Excellence Award!


MORE ABOUT THE AWARD

The winners will have the unique chance to put their most outstanding products, services or best practices in the spotlight, by presenting their projects to the top pharmaceutical and biotechnology management professionals of the region aiming to raise their visibility on the professional horizon.

The organiser - TEG The Events Group - is supporting the winning projects with additional PR activities via more than 40 local and international media partners as well as associations highlighting the best innovations in each category.

PANEL DISCUSSIONS

PANEL DISCUSSION | DAY 1

Data Integrity - How to Interpret the Guidelines into Procedures and to Reduce “Grey Zones”

Dr Piotr Lipiński
Dr Piotr Lipiński

Global Quality Auditor, Audit & Compliance, Europe II


Dr Piotr Lipiński
PANEL DISCUSSION | DAY 1

Data Integrity - How to Interpret the Guidelines into Procedures and to Reduce “Grey Zones”

Izabela Majić
Izabela Majić

Head of Inspectorate


Izabela Majić
PANEL DISCUSSION | DAY 1

Data Integrity - How to Interpret the Guidelines into Procedures and to Reduce “Grey Zones”

Ivan Bašic, PhD
Ivan Bašic, PhD

GMP Inspector Expert


Ivan Bašic, PhD
PANEL DISCUSSION | DAY 1

Data Integrity - How to Interpret the Guidelines into Procedures and to Reduce “Grey Zones”

Lenka Francišković
Lenka Francišković

Head of Processes and Products Quality


Lenka Francišković
PANEL DISCUSSION | DAY 2

Serialisation – How to Meet the Expectations and Increase Supply Chain & Patient Security?

Geoffroy Bessaud
Geoffroy Bessaud

Associate Vice President, Corporate Anti-Counterfeiting Coordination Corporate Security


Geoffroy Bessaud
PANEL DISCUSSION | DAY 2

Serialisation – How to Meet the Expectations and Increase Supply Chain & Patient Security?

Vasil Pavlov
Vasil Pavlov

Plant Manager


Vasil Pavlov
PANEL DISCUSSION | DAY 2

Serialisation – How to Meet the Expectations and Increase Supply Chain & Patient Security?

Tamás Rácz
Tamás Rácz

Director - Global Serialization Implementation / EU sites


Tamás Rácz

PLANT EXCURSIONS

Explore the enchanting world of factories as a PHARM Connect VIP visitor! Each year, participants of PHARM Connect are given a unique chance to visit and experience various pharmaceutical manufacturing sites of market-leading organisations.

11th March 2019 | 15:00

Site visit to Meditop Pharmaceutical

Site visit to Meditop Pharmaceutical - The Winner of the 3rd CEE Pharmaceutical Manufacturing Excellence Award


Participants of PHARM Connect 2019 can learn more about the award winning innovation and visit the Meditop Pharmaceutical plant near Budapest. It is limited for 35 delegates only and available on a complimentary, first-come, first-served basis at 15:00 on 11th March.

TRANSFER:  The bus will leave from the front entrance of the Novotel Budapest City Hotel which is connected to the Budapest Congress Centre on 11th March at 14:00 and will return after the visit at approximately 18:00.


Meditop Pharmaceutical Ltd. as a middle size company develops and manufactures its own products and offers services as a Contract Manufacturing Organisation to produce solid dosage forms in flexible manner and to provide support in development and manufacturing of pharmaceutical and nutraceutical products suffering with special sensitivity.

Meditop Pharmaceutical developed an innovative approach to improve film coating efficiency with developing and applying of a continuous film coater for which they received the 3rd CEE Pharmaceutical Manufacturing Excellence Award. With the innovation they:

  • Successfully developed a method to coat soft tablets with high quality,
  • Managed to coat heat sensitive actives without degradation,
  • Saved considerable time and energy, and
  • Obtained flexible and fast change-over and batch size change.
11th March 2019 | 15:00

Site visit to the Gedeon Richter Biotechnology plant in Debrecen

Site visit to the Gedeon Richter Biotechnology plant in Debrecen


The congress also provides an opportunity to visit the Gedeon Richter Biotechnology plant in Debrecen limited for 40 delegates and available on a first come first serve complimentary basis at 15:00 on 11th March and will last for approximately 2 hours.

TRANSFER: The bus will leave from the front entrance of the Novotel Budapest City Hotel which is connected to the Budapest Congress Centre on 11th March at 12:00 and will return after the visit at approximately 19:30.


Gedeon Richter Plc. embarked on establishing biotechnology development and manufacturing capabilities over a decade ago. As a result, the company today has established sites and teams covering R&D and production activities to enable the creation of a biologics product pipeline in addition to offering CDMO activities in the biopharmaceuticals field.

The company has state-of-the-art manufacturing facilities covering microbial fermentation-based products at its Richter-Helm Biologics sites in the north of Germany, and mammalian cell fermentation-based manufacturing capacities, in addition to fill and finish capabilities at its plants on the Gedeon Richter site in Debrecen, Hungary.

The Debrecen GR site covers production, development, analytical testing and releasing activities on a greenfield site that has expanded continuously over past years, providing a workplace for nearly 300 highly skilled associates, benefiting from the growth momentum and strong higher education credentials of the city of Debrecen.

Your visit to the Gedeon Richter site will provide you with a good overview of the unique capabilities and assets of the facilities covering manufacturing, development and analytical areas. This will be followed by a site tour including the viewing corridor of the drug substance manufacturing upstream fermentation area and the visit of a laboratory. The tour will finish with a brief outdoor walkaround of the site and a wrap-up meeting with refreshments. The 40 participants will be split into 2 groups for the site tour.

13th March 2019 | 17:00

Site visit to the SANOFI plant in Budapest

Site visit to the SANOFI plant in Budapest


The congress also provides an opportunity to visit the SANOFI plant in Budapest limited for 100 delegates and available on a first come first serve complimentary basis at 17:00 on 13th March and will last for approximately 1-1.5 hours.

TRANSFER: The bus will leave from the front entrance of the Novotel Budapest City Hotel which is connected to the Budapest Congress Centre on 13th March at 16:00 and will return after the visit at approximately 19:30.


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.

Delegates will have the opportunity to select among the following 4 focus groups: Warehousing (max. 25 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.

Development Center

The Development Center Ujpest, flagship of Sanofi Active Ingredient Solutions business unit is operating on the Ujpest site. DCU gives the main part of the development potential of SAIS, both in terms of number of employees and capacity.

The Development Center Ujpest name was taken up in 2018 by the organization which was founded with the goals to bridges the differences between the research and development and industry, and translates the laboratory recipes to an industrialized technology.

The current tasks of our organization are wide-ranging, so our customers are very diverse. Our partners include Chemistry of Újpest for whom we give process improvement support to develop and optimize the already industrialized technologies and we also have similar tasks for the Vertolaye site in France. For PG business unit we have been manufacturing non-active intermediates in small volume, and validation of the processes.

Our third-party costumers may require laboratory development of a process, sample preparation/production from a few grams to hundreds of kilograms, GMP production or process validation. We are primarily in contact with Japanese, American and French partners for whom we produce ingredients for early clinical phase. We regularly manufacture commercial products in small volume for which the required technical conditions are available in a high quality. Among other things, this fact and our colleagues’ outstanding expertise, we are present in the Japanese market, which has very high customer needs.

Our activity could not be complete, without a high level of analytical tasks related to the laboratory and plant activities. This should include the analytical method development, their transfer, the examination of laboratory and plant samples, the qualification and release of raw materials, the intermediates and final products for development productions, as well as the stability studies of the products. For those tasks we can use wide range analytical techniques for testing from XRPD, HS-GC, trough HPLC, and HPLC-MS, up to I-Class UPLC and NMR.

The effectivity of our team is well reflected in the fact that, according to the successful development work we could keep so large development projects such as Volixibat or Olmesartan, which has been manufacture in industrial scale since then.

Chemical manufacturing

Chemical production in Újpest site is a prominent organization of Sanofi 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. Today about 50% of the site activity belongs to production of APIs for Sanofi, other 50% of our active products are sold across the globe, from US till Japan.

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 more than 300 colleagues provide for everyday quality of 3000 batches of 28 APIs and their intermediates.

Quality Management

Quality Management is located in one building in the centre of the site. There are the Quality Assurance and Regulatory offices and the main QC activities: chemical and microbiology laboratories, retain and stability sample storage areas and analytical reference standard management. The laboratories are well equipped with modern techniques fulfilling data integrity requirements and providing solution also for the challenging quality requirements such as organic impurities, foreign particle, elemental impurities and physical characters of the APIs. The design of the laboratories is one of the most attractive within Sanofi and all above compliant with GMP and HSE requirements. All visitors and inspector found it very impressive. We are very proud of the results of our Quality System. We have successfully managed the recent inspections led by US, Japanese, Russian and of course Hungarian Authorities.

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 handed 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 2018: 3 344 T products, 13 572 T raw materials, 18 836 T waste materials