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 2020


POST EVENT INFORMATION
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.

CASE STUDY PRESENTATION

Functional HPMC-based Capsules for both Oral Dosage Forms and Dry-powder Inhalation

Frédérique Bordes-Picard
Frédérique Bordes-Picard

Pharmaceutical Business Development Manager


Frédérique Bordes-Picard

Functional HPMC-based Capsules for both Oral Dosage Forms and Dry-powder Inhalation


CASE-STUDY PRESENTATION

MES with Electronic Batch Records - Manufacturing digitalization backbone

Wojciech Kisielnicki
Wojciech Kisielnicki

Finished Dosage Form Manufacturing Director


Wojciech Kisielnicki

MES with Electronic Batch Records - Manufacturing digitalization backbone


• Project scope – manufacturing processes and software, architecture, interfacing with other systems

• Key implementation lessons learnt – initial expectations vs. reality check, key troubleshooting areas, go-live experiences

• Electronic batch record – perspective of operators, QA, inspectors, third parties

• MES as backbone for digitalization within manufacturing area - wider context, how to use the system in building process and product knowledge


Wojciech Kisielnicki, Pharma Manufacturing Director in Polpharma Starogard Site. He started his career in ’90s as a management consultant, undertaking process reengineering and privatization projects. For fifteen years he was developing SCM function of Polpharma, the leading Polish pharmaceutical company, facilitating rapid growth across domestic and international operations.

Wojciech, being responsible for Polpharma Group end-to-end supply chain, was also working on the development of materials management best practices in affiliated pharmaceutical plants and companies. Five years ago he became responsible for finished dosage forms manufacturing in the largest pharmaceutical facility in Poland, consisting of three plants: Solids, Glass Ampoules and Infusions.

CASE STUDY PRESENTATION

Formulation and Manufacturing of Biosimilar Drug Products

Dr Erik Bogsch
Dr Erik Bogsch

Head of the Biotechnology R&D Division


Dr Erik Bogsch

Formulation and Manufacturing of Biosimilar Drug Products


• Formulation challenges of biosimilar drug products – role of excipients, determination of drug product composition

• Selection of primary packaging materials - administration, product stability and other perspectives

• Fill and finish activities from laboratory to production scale

• Stability of biosimilar drug products – applied analytical techniques, types of stability studies

• Biosimilarity / Comparability at DP level


Dr Erik Bogsch is the Head of the Biotechnology R&D Division at Gedeon Richter Plc. He is responsible for leading the R&D effort in the development of GR's biosimilar pipeline. Gedeon Richter Plc. is engaged in the development and manufacture of both bacterial cell fermentation based and mammalian cell fermentation based biosimilar products. GR has R&D, analytical & manufacturing capabilities in multiple locations in Hungary & Germany.

Dr Bogsch, a Hungarian national, has a Natural Sciences degree from the University of Cambridge and a PhD in cell biology from the University of Warwick. Following a brief postdoctoral academic research career, he worked in the food industry for many years in R&D, Quality & Manufacturing roles in the UK, Hungary & Germany. He joined Gedeon Richter Plc. in 2012, as commissioning lead for GR's biotechnology factory in Debrecen, Hungary, before moving into his current role.

CASE STUDY PRESENTATION

How to choose the best API & raw material suppliers?

Dr Piotr Lipiński
Dr Piotr Lipiński

Global Quality Auditor, Audit & Compliance, Europe II


Dr Piotr Lipiński

How to choose the best API & raw material suppliers?


• Lessons learnt from the impurity case of Valsartan

• How to avoid similar problems in the future?

• How to provide high quality API products and raw materials to pharma companies?

• What is the channel for API selection? - Indian vs. Chinese vs. EU APIs

• How to avoid impurities, esp. elemental, toxic impurities?


Piotr has over 12 years of experience in pharmaceutical companies. Currently, he is a Global Quality Auditor in Novartis, before he worked in pharmaceutical manufacturing sites as Quality Assurance Specialist, Qualified Person and Quality Systems Manager.

The experience includes particularly quality systems implementation, self-inspections, training and auditing of materials, products suppliers and service providers. Piotr has detailed knowledge in the scope of all GxP rules with a special focus on Good Manufacturing Practice and Good Distribution Practice.

Piotr is a PhD Eng. in the scope of Technology of Chemistry. Additionally, he completed post-graduate studies in the scope of Industrial Chemistry at the Medical University of Gdansk. He was participating as well in numerous courses related to GMP aspects in the pharmaceutical industry.

CASE STUDY PRESENTATION

How to implement Ongoing Process Verification of the Process Validation Life Cycle in the routine Production?

Izabela Majić
Izabela Majić

Group Quality Director


Izabela Majić

How to implement Ongoing Process Verification of the Process Validation Life Cycle in the routine Production?


• What are the differences between Continued (CPV) and Ongoing Process Verification (OPV)?

• What are the expectations of inspectors?

• How is OPV linked to Product Quality Review (PQR)/ Annual Product Review (APR)?

• What statistic parameters could help and what tools can be used?

• What situations can happen and examples on what to do in certain situations?

• Is the process capable and compliant for the production?


Izabela Majić is a pharmaceutical quality and regulatory management professional and leader with years of experience in both industry and regulatory. Currently, she is a Group Quality Director at Dechra Pharmaceuticals. Before she held a position as a head of successful Inspectorate - recognised by the FDA among first 8 EU Inspectorates, a PIC/S member and was rated with highest grade 5 during benchmarking audit (BEMA) of regulatory agencies in December 2018. She shows high involvement in international cooperation in the area of GMP and GVP, PIC/S, EMA, MRA, EDQM.

Before joining the Agency, she gained strong Quality and Manufacturing background in global companies such as Teva and start-up pharmaceutical facilities with both managerial and operational functions.
The experience includes implementation of QMS and validation of IT systems, manufacturing processes (parenterals, API (synthetic, fermented), biotechnological products, dry oral dosages and topicals) and equipment and analytical methods.

CASE STUDY PRESENTATION

Serialisation, the Past, the Present and the Future

Neil Lawrence
Neil Lawrence

Global Serialisation Champion, Global Manufacturing and Supply


Neil Lawrence

Serialisation, the Past, the Present and the Future


• The Origins of Serialisations and the fight against fakes

• The current global trend and the need for Harmonisation

• Lessons learned and the emergence of UDI and Cosmetics UPI

• Future opportunities and how to build on the foundation


Neil Lawrence has been successfully leading the global implementation of serialisation at GlaxoSmithKline for 4 years, having previously lead a globally recognized patient safety programme for the Department of Health in the UK.

Working with competent authorities, standards associations, trade groups and many other stakeholders to ensure levels of patient safety are increased and counterfeit medicines are decreased from the supply chain, Neil drives forward GSK’s adoption of global standards and pack safety features to ensure the protection of our patients.  

CASE STUDY PRESENTATION

Capacity Planning Model in QC Laboratory

Olga Bartocha
Olga Bartocha

Quality Control Manager


Olga Bartocha

Capacity Planning Model in QC Laboratory


• How to understand capacity in QC Laboratory?

• What testing model is good for your laboratory?

• Key factors for successful planning

• Tactical & operational planning

• RCI


Olga Bartocha has been working in pharmaceutical industry for 16 years. Olga is a Pharmaceutical Professional in the field of quality control, quality auditing, project management and contract services. She has the knowledge of pharmaceutical technologies: solid dosage forms and sterile manufacturing (glass ampoules, infusions). Olga started her carrier in 2003 in Pharmaceutical Works Polpharma S. A. holding several specialist and manager positions in quality control as well as in contract manufacturing.

In 2017, Olga joined Novartis and became Quality Control Manager. In this role, Olga is responsible for Novartis Quality Control in Poland.

CASE STUDY PRESENTATION

Digitalization, Industry 4.0

Tomasz Pałka
Tomasz Pałka

Production Head


Tomasz Pałka

Digitalization, Industry 4.0


• Digitalized shop floor on the example of solid dosage form production

• Mature usage of MES on shop floor (benefits and issues basis on 10 years of experience)

• Production efficiency monitoring systems

• Application of 3D printing

• Work/ reports automation with SAP and MS Excel

• Robotics

• Ongoing projects and future plans (automation master plan, CMMS, MES upgrade, VR/ AR)


Tomasz Pałka, Production Head in Novartis Warsaw Site. Professional career started in 2008, from the beginning in operation structures. After 8 years, in various positions (e.g. Technology and Laboratory Manager, Production Manager) in Reckitt Benckiser company, for over three years at Novartis Technical Operations. Experienced in the technology of liquids, powders and solid forms.

Interested in psychology in the context of people management and process improvement. Tomasz is a mechatronics engineer, graduated at Military University of Technology and the MBA program at the Kozminski University.

CASE STUDY PRESENTATION

Digitalization, Industry 4.0

Piotr Wojciechowski
Piotr Wojciechowski

MES Manager


Piotr Wojciechowski

Digitalization, Industry 4.0


• Digitalized shop floor on the example of solid dosage form production

• Mature usage of MES on shop floor (benefits and issues basis on 10 years of experience)

• Production efficiency monitoring systems

• Application of 3D printing

• Work/ reports automation with SAP and MS Excel

• Robotics

• Ongoing projects and future plans (automation master plan, CMMS, MES upgrade, VR/ AR)


Over 14 years experience in pharma industry of solid dosage forms production. Currently holds role of Production Support Systems Manager at Novartis Poland acting as bridge between IT and business.

Before, successfully held different roles starting on shop floor (supervisory of dispensing and granulation area) through different positions in supporting production within MES and SAP systems as well as managing projects and teams. Broad knowledge of IT systems implementation, integration, maintenance and validation. The experience include also team management, SAP Super User role, application development (KPI measurement), reports design, process handling (MBR), work automation, paperless production, architecture and standardization advisory. Currently focused on shop floor digitalization and work automation. Bachelor of engineer in Computer Science and graduate Pharmaceutical College gives unique opportunity for understanding and digitalization of pharmaceutical production processes.

CASE STUDY PRESENTATION

Quality Assurance for Single Use Systems: Implementation and Validation, Integrity, Transport and Packaging

Patrick Evrard
Patrick Evrard

Sr. Principal Engineer, Single-use Technologies


Patrick Evrard

Quality Assurance for Single Use Systems: Implementation and Validation, Integrity, Transport and Packaging


• Broad usage of single use technologies, SUT, evolves into commercial operations and drug manufacturers look for solutions to industrialize its usage in a safe and reliable way

• With SUT adoption, quality ownership involves shared responsibilities between supplier and end user

• Part of supply and quality chain shifts to supplier

• Join us to discuss existing good practices to ensure critical quality attributes (CQAs) of the SUS throughout their life cycle


Patrick Evrard joined Pall Biotech in 2017, and is providing expert technical, validation and regulatory support, as well as being an internal "voice of the end-users" on the single-use technologies. Specific fields of expertise are: redesign processes with single-use technologies to achieve closed systems operation, aseptic processing, particles and integrity control for single-use systems. Before joining Pall, he led for more than 10 years a global technical team in charge of developing and implementing single-use technologies in GSK Vaccines' commercial manufacturing operations. Patrick and his team implemented at global level single-use technologies in critical sterile applications and re-engineered several vaccines processes, switching from classical grade A open processes to closed systems ones.

Patrick has written and contributed to several articles and white papers on single-use technologies, was part of the Board of Directors of the Bio-Process Systems Alliance (BPSA). He has been participating since 2012 in several single-use technology industry work groups, from BPSA, BioPhorum Operations Group (BPOG), American Society of Mechanical Engineers (ASME BPE) and ASTM International.

PRESENTATION

WINNING PROJECT OF THE MANUFACTURER & SOLUTION PROVIDER CATEGORY

Apply for the 6th 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 30 local and international media partners as well as associations highlighting the best innovations in each category.

CASE STUDY PRESENTATION

Bioanalytical method validation according to draft ICH M10 Guideline

Piotr Rudzki
Piotr Rudzki

Head of Pharmacokinetics Department, Steering Committee Director of ORBIS project Horizon2020-MSCA-RISE, Lukasiewicz Research Network - Pharmaceutical Research Institute


Piotr Rudzki

Bioanalytical method validation according to draft ICH M10 Guideline


• Reliability in bioanalysis (focus on small molecules)

• ICH M10 – a hybrid EMA and FDA guideline?

• What is missing & future perspective


Pharmacist with over 15 years in a GLP-certified laboratory, involved bioequivalence projects (bioanalysis, pharmacokinetics, statistics). Head of Pharmacokinetics Department at Łukasiewicz Research Network – Pharmaceutical Research Institute since 2009, director of ORBIS project Steering Committee (Horizon 2020). D.Sc. in medicine and health sciences (2019), co-author of over 30 papers and over 50 conference communications, involved in the EMA public consultations, author of expert opinions and pharmacokinetic study designs.

PANEL DISCUSSION

TRAINING OF PERSONAL & FINDING THE BEST CONSIDERING THE LACK OF WORKFORCE

 What strategies are Pharm companies applying to address the lack of qualified people?  Most efficient training methods due to high fluctuation of staff and migration of young professionals to Western Europe • Impact on R&D, growth and new investments in CEE  Gap between the competences of University graduated specialists and expectances of Pharma Industry • How can outsourcing support the processes, esp. outsourcing of R&D?

Olga Nazaruk
Olga Nazaruk

Training and Development Manager


Olga Nazaruk
Dr Piotr Lipiński
Dr Piotr Lipiński

Global Quality Auditor, Audit & Compliance, Europe II


Dr Piotr Lipiński
Rafał Maludziński
Rafał Maludziński

Head People & Organization (HR)


Rafał Maludziński
Dr Sergii Sur
Dr Sergii Sur

Regulatory Affairs Director


Dr Sergii Sur
István Király
István Király

Managing Director of HUMAN BioPlazma


István Király

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.

9th March 2020 | 10:00

Site visit to the Novartis plant & packaging center in Stryków

Site visit to the Novartis plant & packaging center in Stryków


The congress also provides an opportunity to visit the Novartis plant in Stryków limited for 50 delegates and available on a first come first serve complimentary basis at 10:00 on 9th March and will last for approximately 3 hours.

TRANSFER: The bus will leave from the front entrance of the Warsaw Marriott Hotel on 9th March at 8:30 and will return after the visit at approximately 15:00.


Novartis plant in Stryków

Bulk – production:

Bulk unit in Styków (BCS) is modern, big scale facility production center focused on manufacturing of generic solid dosages drugs.

Facility opened in 2004 and originally planned for around 1billion tablets today, in the same foot print has an impressive capacity of + 10 billion.

BCS plays significant role in Novartis Technical Operations network supplying over 7 billion tablets (from around 4000 batches) on yearly basis serving two packaging facilities in Poland as well as customers in Canada, Slovenia and Germany.

Innovative approach to mature generic products and fit to purpose and standardized equipment allows efficient manufacturing processes and as consequence very competitive costing for our customers and eventually for Patients around the world.

Current product portfolio concentrates around alimentary tract and metabolism (mostly metformin) and cardiovascular (bisoprolol, ramipril and torademide).

Quality:

Quality Unit consists of Quality Assurance and Quality Control. Quality Assurance teams are located according to main responsibilities – close to Production Unit for Operational QA and in the office building for Quality System, compliance and Technical QA.

Quality Control has QC laboratories in two locations. All our laboratories (chemical, microbiological and packaging material lab) are well equipped with modern techniques fulfilling data integrity requirements. They test raw materials, API, finished products and packaging materials. Central Testing Laboratory provides analytical testing services for other manufacturers in the scope of release testing, EU re-testing and stability testing and stability management. QC Lab is certified for Lean Lab management, supported with planning tools and continuous improvement. QC team has also well-developed Analytical Science & Technology team responsible for analytical methods development, transfer and validation. The design of the laboratories is compliant with GMP and HSE requirements.

Warehouse management:

In Strykow we operate two automated warehouses dedicated to: bulk and packaging operations. The first one with a capacity of 7,3 k pallets supports bulk operations and is used for handling and storage of APIs, excipients and bulk manufactured locally prior it is shipped to Packaging Centers. The second one, with 50% bigger capacity (10,7 k pallets), started its operations only in 2015, is dedicated to packaging and used as a distribution warehouse for all products packed in Polish sites. Majority of its capacity is utilized by FDFs, the rest is consumed by primary and secondary packaging materials and bulk (both locally manufactured and imported from other suppliers). The warehouse and packaging operations are equipped with AGVs which ensure fully automated material between both operations. AGVs are also used on the production floor. 

Packaging Center:

PCS started operation in 2015 .We are now in the newest site in Novartis. We are proud that we were able to build and start first production in 1,5 year.

We are operating on 11 highly automated packaging line (Uhlmann BEC 500 and IMA C80/A81 including   serialization units USP 2 )

Currently in Strykow we have potential to increase our capacity additionally an extra 5bn tablets starting 2sc floor up to 24 lines.  Total capacity 10 bn tabs /yearly

PCS have fully automated flow of material (on production and on warehouse). We have also digital flow of production documentation. Werum Sap and WMS are connected together, operator only has to order right material on the line than process work automatically, and AGVs brings the right material to the line. The difference versus standard systems is that our AGVs are guided similar to GPS navigation. Thanks to laser on top, AGV set their position communicating with at least three reflectors in each time.

We are using an Online monitoring production execution system ANT that allow to us trace online results and problems on each line using laptop or even cell phone what ensures fast reaction.

We are also equipped in automated format parts washer that help us to reduce time of cleaning and drying.

Key numbers (2019):

  • Total pallets shipped to customers (Finished Dosage Form) ~ 60 k, over 1000 trucks
  • Total pallets received ~ 25
  • Total number of pallet on stock ~14,5 k

 

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