Chairperson 

Dr. Mahwash Mukhtar is currently a Research fellow at the Institute of Pharmaceutical Technology and Regulatory Affairs at the University of Szeged (Hungary). She acquired her Ph.D. in Pharmaceutical Technology from the University of Szeged in 2022. She has previously been working as a principal scientist in different Hungarian, Hungarian-Croatian, and Hungarian-Pakistani bilateral projects, along with a visiting researcher in CiMUS, University of Santiago de Compostella (Spain).

Her areas of expertise include macrophage-targeted drug delivery in inflammatory disorders, pulmonary dry powder nanomedicines, anti-biofilm coating of 3D printed catheters, oral nano-mediated drug delivery, and in-vivo studies. Moreover, she is also working on the chemical derivatization of biocompatible polymers to improve therapeutic outcomes, especially in dealing with antibiotic and antimicrobial resistance.

Her educational and research achievements have been recognized by the Higher Education Commission, Pakistan. She has won many grants such as Stipendium Hungaricum, International travel fellowships, and an honorary Master’s degree in Science from the University of Lahore (Pakistan). Her research has been published in high-ranked journals; she is also an active member of the Aerosol Society (UK), Pakistan Pharmacists’ Association, and American Chemical Society and is serving as an editor in highly esteemed journals.

 Chairperson 

Jessica Helbling is currently a Research Associate and PhD Candidate at the Division of Production Management at the University of St.Gallen (Switzerland). She holds a Master of Arts in Business Innovation from the same university.
Within the institute, she is primarily responsible for Quality Management, Quality Control, and Quality Assurance projects and initiatives, overseeing Operational Excellence programs and maintaining close collaboration with regulatory authorities.
Her research focuses on quality management and continuous improvement in regulated industries, particularly the pharmaceutical and MedTech sectors, aiming to integrate academic, industrial, and regulatory perspectives to develop actionable and scientifically grounded solutions. She gathers insights through individual projects, benchmarking exercises, and cross-company exchange groups.
In addition to her academic work, Jessica is a qualified ISPE Operational Excellence Trainer, actively contributing to the implementation and advancement of Operational Excellence practices within the pharmaceutical sector.

Topic to be confirmed

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.

Revision of GMP Guidelines Chapter 4 “Documentation”, Annex 11 “Computerised Systems” & New Annex 22 “Artificial Intelligence”

• How to get ready to support innovation in the pharma manufacturing & ensuring regulatory harmonisation

Piotr has over 12 years of experience in pharmaceutical companies. Currently, he is a Global Quality Auditor in Sandoz, 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.

Exploring Digitalization in QC Labs and Its Impact on Excellence

• Current state of digitalization in QC Labs
• Data-driven insights and trends
• Concrete use cases

Jessica Helbling is currently a Research Associate and PhD Candidate at the Division of Production Management at the University of St.Gallen (Switzerland). She holds a Master of Arts in Business Innovation from the same university.

Within the institute, she is primarily responsible for Quality Management, Quality Control, and Quality Assurance projects and initiatives, overseeing Operational Excellence programs and maintaining close collaboration with regulatory authorities.

Her research focuses on quality management and continuous improvement in regulated industries, particularly the pharmaceutical and MedTech sectors, aiming to integrate academic, industrial, and regulatory perspectives to develop actionable and scientifically grounded solutions. She gathers insights through individual projects, benchmarking exercises, and cross-company exchange groups.
In addition to her academic work, Jessica is a qualified ISPE Operational Excellence Trainer, actively contributing to the implementation and advancement of Operational Excellence practices within the pharmaceutical sector.

Technology Transfer and Technology Advancement at Industrial Biotechnology

• Technology transfer: Bridge between R&D and Production
• Technology advancement impact on productivity, moving from lab-scale to pilot and full-scale production
• Regulatory and Quality Considerations, ensuring reproducibility and traceability during process changes
• Collaboration and Knowledge Management, the importance of training  

Soma Stamler is a Biotechnology Platform Manager with extensive experience in biotechnology, industrialization, and technology transfer within the pharmaceutical and animal health sectors. Currently serving at CEVA Santé Animale in Budapest, leading a global industrialization platform, managing a team of 10 experts and overseeing multiple technology transfer projects. This role focuses on enhancing productivity and quality of existing products, driving strategic improvements, and implementing advanced process technologies aligned with industry trends.

With a background in process optimization, scale-up strategies, and regulatory compliance, successfully directed complex improvement projects and evaluated technological and financial impacts of innovative solutions. Prior to his current role, he served as Technology Transfer Expert, where he managed industrialization projects, defined process validation strategies, and provided cross-functional expertise to R&D, QA, and RA teams.

Earlier in his career, Soma gained international experience at Lonza Netherlands, leading cell therapy manufacturing operations and managing a team of biotech associates. His responsibilities included ensuring cGMP compliance, overseeing technology transfers, and driving operational excellence through process and training improvements.

Soma holds an MSc in Engineering Management from Széchenyi István University and a BSc in Biochemical Engineering from Budapest University of Technology and Economics. His academic work focused on production optimization and fermentation processes, complementing his practical expertise in bioreactor operations and vaccine production technologies.

Concept of Internal Branding as a Backbone of the Ever-Changing Environment in Pharma 

Petra works as a managing director in Cayman Pharma (Czech Republic), a company focused on API products based on prostaglandin skeleton. By training, she is an analytical chemist with high appreciation of chromatographic and mass spectral techniques. She is very passionate about her job while trying to combine different aspects of pharmaceutical world into one single concept: reliable production of pharmaceutical products in high quality and with significant added value. Petra strongly believes in focused team work and in workplace diversity. As such, she has a high appreciation of employees in Cayman Pharma as the most important moving force of the production process.

IVDR-compliant Development of in Vitro Diagnostics – Interplay between Pharma & Medical Device Industries

• The new regulatory framework for developing in vitro diagnostic tests (ISO 13485 and IVDR)
• Development life cycle of IVD tests (including companion diagnostics)
• Special aspects of clinical development
• Impact of IVDR implementation on drug clinical trials in the EU

Zsolt Holló MD, PhD, MBA, PMP

Zsolt Hollo is a medical doctor by training, holding various other degrees and qualifications. He is a biosimilar expert, active in this field for over 14 years.

He is one of the founding scientists of Solvo Biotechnology (a Charles River Company), a pioneering biotechnology company in the drug transporter / ADME-Tox field. He was Medical Director and Chief Operations Officer at Solvo Biotechnology from 2004 to 2009.

He worked at EGIS Pharmaceuticals in 2010-2023. As the Head of the Center of Biotechnology Business Development and Technology, he was responsible for various biosimilar related projects (technology transfer, setting up an EU release testing laboratory, alliance management with a strategic biosimilar manufacturer, due diligence of biosimilar products) and various other R&D projects in chronic inflammatory diseases. He joined Polpharma Biologics in Nov 2023 as alliance management head and since September 2025 is the head of diagnostics development at Rezon Bio.

The new company has been created following the demerger of Polpharma Biologics into two independent companies. Polpharma Biologics in Switzerland now focuses entirely on developing its own biosimilars, while Rezon Bio in Poland positions itself as the cost-efficient partner of choice for the biologics industry. 

Streamlining Biosimilar Development - The Next Step in the Evolution of the Biosimilar Regulatory Pathway

• Developing and manufacturing biosimilar medicines is a complex process, requiring significant expertise and investment over long period of times. There are many different factors impacting the feasibility of biosimilar development: scientific, technological, intellectual property, regulatory, market access, etc. 
• For many biologicals (70%) losing exclusivity over the next decade, do not have corresponding biosimilar medicines in development, resulting compromised opportunities for HC systems and patients across Europe. The ‘Void’ impacts BOTH blockbuster medicines and medicines intended for smaller population.  
• One of the ways of mitigating this ‘Void’, without compromising safety or efficacy, is the implementation of streamlined biosimilar development. Streamlining aims to eliminate comparable efficacy studies (or CES, so called ‘Phase III’) by relying on advanced analytical and clinical pharmacokinetic data. Under the current requirements, CES constitute an absolute barrier to biosimilar development. 
• Ensuring a brighter future for the biosimilar industry requires, but is not limited to: 

• evolving the biosimilar regulatory standard based on biologic regulatory-science progress,
• engaging stakeholders,
• promoting global regulatory convergence 

• to support a balanced and functioning biosimilar ecosystem. 

Mina Grguri is the Biosimilar Science and Policy Officer at Medicines for Europe, the trade association representing the generic, biosimilar, and value-added medicines industry. In her role, she is focusing on the Biosimilar regulatory and science Policy, advocating for a strong EU biosimilar industry and the evolution of the biosimilar regulatory framework in line with the scientific advances of today, with the goal of increasing patient access to innovative biologic therapies across Europe. Mina is active on the topic of streamlining Biosimilar development both at EU and International level, coordinating expert taskforces and engaging with external stakeholders.

A pharmacist by education, Mina has previously worked in the sphere of clinical trials at a global CRO company.

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 3^rd March and will last for approximately 2 hours.

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 400 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 walk around of the site and a wrap-up meeting with refreshments. The 40 participants will be split into 2 groups for the site tour.

TRANSFER: The bus will leave from the front entrance of the Hotel on 3^rd March at 12:30 and will return after the visit at approximately 19:30.