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

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

Lean Principles in the Biotech Pharma Industry

Dr János Dombovári
Dr János Dombovári

Project Manager, Biotechnology Division


Dr János Dombovári

Lean 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

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

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


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 of the Agency for Medicinal Products and Medical Devices of Croatia, HALMED

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 DISCUSSION I.

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
Izabela Majić
Izabela Majić

Head of Inspectorate


Izabela Majić
Ivan Bašic, PhD
Ivan Bašic, PhD

GMP Inspector


Ivan Bašic, PhD
Lenka Francišković
Lenka Francišković

Head of Processes and Products Quality


Lenka Francišković

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


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.

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.

13th March 2019 | 17:00

Site visit to the SANOFI plant in Budapest

Site visit to the SANOFI plant in Budapest


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.


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 18:30.