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 2021


POST EVENT INFORMATION
CHAIRMAN

 

 

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).

CASE-STUDY PRESENTATION

Live Processes around Electronic Batch Records (EBR)

Joanna Nowak
Joanna Nowak

Process Engineering Coordinator, Solid Forms Manufacturing Technology Team


Joanna Nowak

Live Processes around Electronic Batch Records (EBR)


• Project scope – implementation of Electronic Batch Record in the manufacturing area

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

• Quality assurance expectations vs. perspective of manufacturing area

• Challenges for batch release caused by implementation of EBR


CASE STUDY PRESENTATION

Factory-of-the-Future: How digital shapes the new ways of working at Takeda

Roland Straub
Roland Straub

Global Head of Digital Supply


Roland Straub

Factory-of-the-Future: How digital shapes the new ways of working at Takeda


• Usage of automation, data and digital tools to reduce bottlenecks, increase capacity and improve the quality of our manufacturing network

• Impact of use of digital tools and robots on people capabilities and how they can shift their focus on value adding tasks


CASE STUDY PRESENTATION

Challenges and lessons learned from remote inspections and audits due to COVID-19

Dr Piotr Lipiński
Dr Piotr Lipiński

Global Quality Auditor, Audit & Compliance, Europe II


Dr Piotr Lipiński

Challenges and lessons learned from remote inspections and audits due to COVID-19


• Advantages and disadvantages of remote audits for auditors / inspectors

• Advantages and disadvantages of remote audits for auditee

• IT and technical solutions and challenges

• Remote audits good practices


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

PAT at the bioreactor: real-time (or in-situ) CPPs and KPI now and future

Nikoletta Emődi-Czakó
Nikoletta Emődi-Czakó

Up-stream Engineer


Nikoletta Emődi-Czakó

PAT at the bioreactor: real-time (or in-situ) CPPs and KPI now and future


• Most common real-time (or in-situ) CPPs: pH, DO, Temperature

• Most common real-time (or in-situ) KPI: VCD

• Another potential CPP: DCO₂

     - Possible advantages in R&D (eg. Scale-up/ scale-down…)

     - Possible advantages in Production

     - Comparison of current technologies for real-time (or in-situ) Dissolved CO₂


CASE STUDY PRESENTATION

Quality Reviews (QR) of contractors in China and India - How to ensure the quality of the product?

Izabela Majić
Izabela Majić

European Commission Expert 

& Group Quality Director


Izabela Majić

Quality Reviews (QR) of contractors in China and India - How to ensure the quality of the product?


• Regulatory expectations - Which types of Quality Reviews are required

• Interpretation of data - What documents and data should be reviewed

• Trending and decision making-interface with risk based audit planning

• Vendor KPI evaluation in the light of quality reviews and audit results


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.

AWARD PRESENTATIONs

 

- Winners' Project Presentations -

Apply for the 7th Central Eastern European Pharmaceutical Manufacturing Excellence Award!


BECOME A WINNER

 Winners' Project Presentations


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.


For further information on the application process, please contact:

Katy Säurich
Head of Operations & Production
Email: katys[at]tegevents.eu

Tel: + 36 1 219-5725

PANEL DISCUSSION

New "post" epidemic realities - How to increase the flexibility & reliability of the Supply Chain

• Lessons learned from COVID-19 and how to react in the future - Are we prepared for future outbreaks?

• New "post" epidemic realities - Be ready for fast & flexible solutions in the case of new epidemics

• Remote working – Ways of working in the future, esp. which pharma roles can be done remotely in the future and how?

• Chance for CEE pharma manufacturers to fill the existing vacuum / gap

Dr János Dombovári
Dr János Dombovári

Head of Site PMO


Dr János Dombovári
Vasil Pavlov
Vasil Pavlov

Plant Manager (tbc)


Vasil Pavlov
István Király
István Király

Managing Director


István Király
Roland Straub
Roland Straub

Global Head of Digital Supply


Roland Straub

PANEL DISCUSSION

Remote auditing & Regulatory affairs at epidemic and quarantine limitations

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Dr Sergii Sur
Dr Sergii Sur

Regulatory Affairs Director


Dr Sergii Sur
Izabela Majić
Izabela Majić

European Commission Expert 

& Group Quality Director


Izabela Majić
Dr Piotr Lipiński
Dr Piotr Lipiński

Global Quality Auditor


Dr Piotr Lipiński
Lenka Francišković
Lenka Francišković

Head of Processes and Products Quality and Lean Six Sigma Green Belt


Lenka Francišković