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ICCBBA Forum 30 MPHO Logo14-15 November 2024
Rome, Italy
The international conference on achieving and sustaining a global consensus for Medical Products of Human Origin (MPHO) safety, biovigilance, and traceability and to protect patients in need of MPHO worldwide. 
 
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Thank you for Attending!
 
If you attended Forum 30, we would love to hear about your experience in a brief 3 minute survey. Thank you!  
 
Take the Survey!
 
A Special Thanks to:
CNS_400x-1
National competent authority for blood and blood components acting as coordinator of the national system. Among others, it is responsible for blood inspectors' qualification through training activities. Learn More
CNT_400x
National competent authority for organs, tissues, cells and MAR coordinating activities from donation to transplantation. Among others, it is responsible for inspectors' qualification through training activities. Learn More
ICCBBA ISBT 128 Standards logo
The International Council for Commonality in Blood Banking Automation (ICCBBA) is the international standards organization responsible for the management and development of the ISBT 128 Standard. Learn More

Tracking, Technology and Tomorrow

Join us in Rome for a transformative experience at the Forum 30 Global Conference!

A pivotal event aimed at advancing the safety and traceability of Medical Products of Human Origin (MPHO) worldwide. Organized by ICCBBA in collaboration with the Italian national competent authorities for blood (CNS) and cells/tissues (CNT), this invitation-only event promises a unique perspective and approach. Mark your calendars, as we gather in the city of Rome, Italy, to embark on a transformative journey.

Together, let's unlock new perspectives, forge meaningful connections and chart the course towards enhanced safety and traceability of Medical Products of Human Origin worldwide. Your participation is not just a contribution to the dialogue; it's a commitment to advancing patient care and donor well-being. Save the date and be a part of this pivotal meeting. Formal invitations with full information will be extended shortly.

Map to Forum 30 at the Istituto Superiore di Sanita
    Day 1
Istituto Superiore
di Sanità (ISS)
 
Start Time: 9:00
End Time: 16:30
Need, Safety, Risk and Availability
How do we achieve the balance between these factors?
Day 2
Istituto Superiore
di Sanità (ISS)
 
Start Time: 8:30
End Time: 15:30
What makes certain MPHO different?
Selected MPHO Across Complex Pathways

Schedule of Events

Day 1
Istituto Superiore
di Sanità (ISS)
 14 November 2024
 
Start Time: 9:00
Break: 10:30 - 11:00
Lunch: 13:00 - 14:00
End Time: 16:30
9:00 - 9:20
Welcome and Opening
Aims of the Meeting and Expected Outcomes
Presenters: 4
  • Joint welcome by the conference co-organizers
Day 2
Istituto Superiore
di Sanità (ISS)
15 November 2024
 
Start Time: 9:00
Break: 11:00-11:30
Lunch: 12:30 - 13:30
End Time: 15:30
9:00 - 10:00
Selected MPHO Across Complex Pathways
Particular aspects that makes them different from other MPHO
Presenters: 3 
  • Tissues: What makes them different?
  • Cells: What makes them different?
  • Medically Assisted Reproduction: What makes it different?
Day 01
Istituto Superiore Di Sanità (ISS)
Start Time: 9:00  | 
End Time: 16:30
  
Session 01
Need, Safety, Risk and Availability
How do we achieve the balance between these factors?
 
Session 02
When Things Go Wrong
Applied traceability in real-world MPHO
 
 
Session 03
Feedback and Conclusions
Review the previous sessions back in the main auditorium
 
Session 04
Donor-related and processing threats affecting MPHO and lessons learned
Emerging infectious disease threats and process-related errors
 


Summary and Close of Day 01
Day 02
Istituto Superiore Di Sanità (ISS)
Start Time: 8:30  |  End Time: 15:30
 
Session 05
What makes certain MPHO different?
Selected MPHO Across Complex Pathways
 
 Session 06
MPHO-based Therapies in the Next 20 Years
What is coming tomorrow that we need to think about today?
  
 Session 07
In Technology We Trust
How healthcare informatics standards & technologies will help us
 
 Session 08
From Forum 25 to Forum 30
How far have we come since 2019?   
 
 
 
 

Summary and Close of Day 02

 

Accommodation and Networking Event

Transportation

To facilitate your journey, we've curated comprehensive transportation options.

  • Air Travel

  • Airport Meet & Greet & Train Service

  • Hotel/Venue Shuttle Service

Lodging

We have partnered with hotels in the vicinity for your stay.

  • Hotel Atlantico

  • Hotel Mediterraneo

  • Hotel Massimo D’azegli

     

Networking Event

Join Us for the Networking Event at Royal Space Rome!

  • FREE For Attendees!

  • Date: 14th November

  • Time: 18:30 - 22:00

Summit Registration

Register the day before the event to receive your Forum 30 kit and badge.

  • Location: Bettoja Mediterraneo
  • Date & Times: 13 Nov 2024 from 17:00 to 19:00 & 14 Nov 2024 from 07:00 to 07:30
     

Speakers & Co-Chairs 

TBD

Mauricio Beltran Duran

WHO-PAHO

Martin Börgel began his career with training as a paediatric nurse. After working for two years at the St. Franziskus Hospital in Münster, he studied business administration in Osnabrück, specialising in healthcare. After receiving his diploma, he worked as an auditor for Solidaris Unternehmensberatung Köln, where he was responsible for the expert audits of the Eurotransplant and the German Foundation for Organ Transplantation (DSO).

Since 2002, he has been managing director of the German Society for Tissue Transplantation (DGFG), which until 2007 operated as DSO-G, a subsidiary of the DSO.

As current president of the European Association for Tissue and Cell Banks (EATCB), as General Secretary of the World Union of Tissue Banking Associations (WUTBA) and member of the European Eye Bank Association (EEBA), he is actively involved in international working groups and political committees to promote and expand donation programs and the supply of tissues in Germany and beyond.

Martin Börgel

World Union of Tissue Banking Associations

Wayne Bolton is Director of the Biological and Clinical Value Stream in Information and Communication Technology (ICT), at Australian Red Cross Lifeblood. He is also Strategic Advisor in the Office of the CIO.

He originally trained in medical laboratory science and worked in a variety of roles in infectious disease testing, molecular biology and laboratory management.
After moving into ICT, he has had a variety of roles across blood management, and transplantation and laboratory information systems, as well as business engagement, and ICT and business strategy.

His current focus is on cloud migration of on-premise enterprise systems, enabling the delivery of manufacturing process and laboratory testing automation and modernization.

He is the current chair of the ICCBBA Standards Committee and also chairs two Technical Advisory Groups. He is also a member of the Information Technology Working Party of the International Society for Blood Transfusion.

Wayne Bolton

Australian Red Cross Lifeblood

Geoff Browne joined STEMSOFT in 1996, working in software development, systems analysis, customer support, software quality assurance, implementation and training. He led the Product Management team at STEMSOFT from 2008 to 2014, moving into product marketing until he assumed the role of Managing Director. Geoff’s expertise in cell therapy and cord blood banking software includes ISBT labeling, instrument and heterogeneous system integration, workflow automation, and reporting. He studied at the University of King’s College and holds technology certifications from Oracle®, Microsoft®, and SAP®, and a product management certification from Pragmatic Marketing®.

Geoff Browne

STEMSOFT Software

Master of Science in International Relations with specialised training in Health Law, European Union Law and project management. From 2013, Head of the International Relations and Projects Office at the Italian National Blood Centre (CNS), which is the national competent authority. Multi-year experience as project manager and coordinator of European projects and joint actions as well as in the organization of national and international dissemination and training initiatives. She contributes to several European working groups, as member or coordinator/co-leader. She actively participates in the definition and elaboration of international agreements, which are related to transfusion medicine, including for the export of plasma-derived medicinal products for humanitarian purpose, and promoted by the Ministry of Health or by the CNS with Ministries, relevant authorities or stakeholders of other Countries. She provides support to review and/or drafting of key European legislation related to blood and blood components.

Livia Cannata

Istituto Superiore di Sanità

Efstratios (commonly known as Stratos) Chatzixiros is from Greece, and he is a Registered Nurse, specialized in the field of Transplant Coordination Procurement and Management. 

He served as Head of the Coordination and Oversight Department at the Hellenic Transplant Organization, with main responsibilities in the national development of deceased donation and the monitoring of organ and tissue transplantation activities. He also supported the establishment and operation of the National Marrow Donor Registry. 

He has also worked for the Italian and French transplantation authorities where he was mainly involved in various European and Global projects with the objective of enhancing quality and safety through the development of tools for vigilance and surveillance and sharing best practices and recommendations. 

As of 2016, he works for the World Health Organization (WHO) Headquarters in Geneva, where he is currently a senior officer (Adviser), responsible for the management of the Organs, Tissues and Cells Transplantation programme. His duties include monitoring the implementation of relevant Resolutions, developing guidance or standard setting material, sharing best practices and providing country support in establishing a national donation and transplantation system.

Efstratios (Stratos) Chatzixiros

World Health Organization

Vincenzo De Angelis, MD, born in 1956.

Graduated in Medicine, Padua University School of Medicine, 1981. Speciality Diploma in Haematology (Padua University, 1984) and Clinical Biology (Padua University, 1988). Since 1982, he has been working in different Italian Transfusion Services (Pordenone General Hospital, Aviano National Research Cancer Institute, Trieste University Hospital, Udine University Hospital).

At present he is the Director at the Italian National Blood Centre, Ministry of Health, the Italian Competent Authority on blood. He also acts as Chairperson of the CD-P-TS at the EDQM (Council of Europe, Strasbourg) and President of the European School of Transfusion Medicine (ESTM). He is Member of the European Blood Alliance and of the ISBT Working Parties on Clinical Transfusion and Donors and Donations.

Author or co-Author of more than 150 publications (chapters on books, articles, abstracts) on different aspects of transfusion medicine.

Vincenzo de Angelis

Italian National Blood Centre at Istituto Superiore di Sanità

Dragoslav Domanović is a medical doctor and a specialist in transfusion medicine. He holds a master's degree and a doctorate in the investigation of peripheral blood stem cells. Working experiences gained at the National Institute for Transfusion Medicine Ljubljana, Slovenia. Last 10 years he has been working as a principal expert for the microbiological safety of substances of human origin at the European Centre for Disease Prevention and Control, Stockholm, Sweden. The main expertise and areas of interest: scientific advice in the transmission of communicable diseases through substances of human origin response to outbreaks and risk assessments of infectious diseases transmissible through substances of human origin preparedness for the safety of supply with substances of human origin epidemiology of donor-derived infection emerging infectious diseases and the safety of substances of human origin. Since January 2022, he has been working part-time as a medical director of the European Blood Alliance.

Dragoslav Domanović

European Blood Alliance

Dr Mohammed Farouk, MD, MBA

Dr Farouk is a medical doctor specializing in "Transfusion medicine" and "Human Tissues and Cells". He got his medical degree from the Faculty of Medicine of Cairo University, Egypt, and he holds a master degree in Healthcare Business Administration from Clarkson University, USA. Dr Farouk has almost 25 years of professional experience, he implemented many EU, WHO, USAID, GIZ, and Swiss Red Cross projects in Eastern Europe, Balkans, Middle-East, Africa, and the Far-East in fields of blood transfusion, Human tissues and cells, HIV, and maternal health.

Currently, Dr. Farouk is the managing director of the Africa Society for Blood Transfusion (AfSBT) and the key expert of the EU project of restructuring Ukraine's public-health system. In addition, he is the Vice-Chair of ICCBBA Board, a member of AABB Global Transfusion Forum, and a member of the international Advisory Committee of the Transfusion Medicine Institute (IDTM), Netherlands.

Mohammed Farouk

Africa Society for Blood Transfusion (AfSBT)

As of March 12, 2024, Dr Feltrin is the Director General of the National Transplant Center, the coordinating body of the Italian Transplant Network, located at the premises of the Istituto Superiore di Sanità. He graduated in Medicine and Surgery and specialized in Cardiac Surgery at the University of Padua. From January 1, 2016, and until March 10, 2024, he served as Regional Transplant Coordinator of the Veneto Region.
 
In previous years, he was also Director of the UOSD Regional Transplant Center, Azienda Ospedale-University of Padua, and Head of the Regional Transplant Coordinating Structure of the Veneto Region.

He has participated and participates in numerous national and international projects and is the author of more than 70 scientific publications in the field of donation and transplantation, as well as innovative technical procedures at regional and national level.

Giuseppe Feltrin

Italian National Transplant Centre

Sebastian Galeano is a member of the Hospital Británico Hematology Department-Bone Marrow Transplant Program and Associate Professor of Hematology at the CLAEH University in Montevideo, Uruguay. He achieved his medical degree in 1996 and has specialty degrees in Internal Medicine and Hematology as well as certification in Bone Marrow Transplant from the Universidad de la República (UDELAR), Montevideo, Uruguay. He is Treasurer of the Sociedad de Hematología del Uruguay (SHU), Secretary of the Worldwide Network for Blood and Marrow Transplantation (WBMT) and Past-President of the Latin American Bone and Marrow Transplantation Society (LABMT).

Sebastian Galeano

Worldwide Network for Blood & Marrow Transplantation

Dolores Hernandez, MD, PhD Hematologist, with more than 20 years experience in stem cell transplantation (SCT) and transfusion medicine. Current position at the Organización Nacional de Trasplantes (ONT), national competent authority for organs, tissues and cells. At ONT, I coordinate the national SCT (bone marrow and cord blood) programs and tissue transplant programs. Active member of the Spanish delegation of the Ministry of Health for the development the new SoHO Regulation which will replace the rules for safety and quality set out in two Directives (2002/98/EC, for blood and blood components, and 2004/23/EC, for tissues and cells), and their implementing acts. The Regulation, already formally adopted by the EU Parliament and the Council will apply in 2027 and will replace the rules for safety and quality set out in two Directives (2002/98/EC, for blood and blood components, and 2004/23/EC, for tissues and cells), and their implementing acts.

Dolores Hernandez

Organización Nacional de Trasplantes

My background in Medicine (Plastic surgery / Burns) and skin bioengineering (PhD – University of Sao Paulo) triggered an interest in skin banking which, over the years, expanded into other Medical Products of Human Origin. In 2007 I moved to Australia where I was Head of the Donor Tissue Bank of Victoria until 2014. I currently hold a position as Associate Professor (Hons) at the Department of Health Ethics and Professionalism at Deakin University. Over the years, I have had the privilege to contribute to the field via peer reviewed publications and presentations, in diverse national and international advisory roles:
 
(Commonwealth Dept. of Health–AU, Australian Organ and Tissue Authority, SNT-Brazil, TGA-AU, ANVISA – Brazil, Hema-Quebec-Canada, WHO)
 
Via commissioned work:
(PAHO, SNT-Brazil, Commonwealth Dept. of Health–AU)
 
In scientific societies:
(ALABAT, BAA, WUTBA)
 
Other collaborations:
(Monash University, Australian National Medical Council, International Atomic Energy Agency, Project NOTIFY, ICCBBA)

Marisa Herson

Deakin University - Health Ethics and Professionalism School of Medicine, Faculty of Health

Martin Hildebrandt graduated from the Free University Berlin in 1993 and was board certified in Internal Medicine, Hematology, Oncology and Transfusion Medicine. With EU-funded projects like ACADEMIC GMP and AGORA, he contributed to the positioning of Academia in the development of cell and gene therapies. Prof Hildebrandt was in charge of Academic GMP facilities in Berlin and Hannover, Germany, and established TUMCells, an ATMP facility at the Technical University of Munich. He was Vice Director of the Division of Transfusion Medicine at the University of Munich, and is Head of the Apheresis Unit, Senior Consultant and Transfusion Officer at TUM Medical School.

Prof. Hildebrandt is member of the National Working Group on blood-associated infections, Chair of the Ethics Committee of the State of Berlin, advisor to the German Working Group on Chronic Rare Diseases and member of the National Strategy for Gene and Cell Therapy.

Martin Hildebrandt

TUM University Hospital

Dr. Jelena Holovati is a Professor in the Department of Laboratory Medicine and Pathology at the University of Alberta, Canada, and a Laboratory Director for the Stem Cell Manufacturing Program at the Canadian Blood Services, including Ottawa and Edmonton stem cell manufacturing centres. She also serves as a director of the Graduate Studies Program at University of Alberta, scientific consultant with the Alberta Health Services Tissue Transplant Program and an accreditation inspector for International Foundation for the Accreditation of Cellular Therapy. Dr. Holovati joined the ICCBBA Board of Directors in 2024. She continues to serve on several international and national committees, including, American Association of Blood Banks Cell Therapy Standards Committee, Health Canada Lymphohematopoietic Cells Standards Committee, International Society for Cell Therapy Lab Practice Committee and Canadian Society for Transfusion Medicine Education Committee.

Jelena Holovati

University of Alberta, Canadian Blood Services

Kathleen Hopping currently serves as Senior Director of Regulatory Affairs at Vitalant, a leading US blood and biotherapies healthcare organization. She has organizational responsibility for interpretation of and compliance to laws and regulations and has built US government relationships through hundreds of blood license Chemistry Manufacturing and Controls (CMC) submissions, to include labeling submissions. In a prior role she was VP of Regulatory Affairs at BioCare, a $1B company. In this role she worked to apply GS1 Standards for FDA Drug Supply Chain Security Act and Traceability compliance. Ms. Hopping’s journey with ICCBBA began in 2018. She currently serves as the chair of the ATAG and has participated in ATAG as a Technical Expert and Chaired one of the subcommittees (Bacterial Testing Strategies for Platelets - US Guidance). Her active involvement and leadership within ICCBBA highlight her dedication to advancing ISBT 128 standards and best practices in labeling automation.

Kathleen Hopping

Vitalant

Fintan Jordan is an Associate Director for Supply Chain and External Alliance at Horizon Therapeutics Ireland. He has been responsible for the end to end supply chain planning of Horizon’s rare disease product portfolio since 2016. He is also responsible for the relationship management of Horizon’s global external alliance partners.
 
Fintan studied International Languages & Marketing and speaks fluent French & Spanish. He has worked in the Irish pharmaceutical sector since 2000, working in a variety of different supply chain roles. He has previously worked in the Biopharmaceutical sector with Chiron Blood Testing, Gilead Sciences and Biomarin working on roll out of ERP integration systems, Master Scheduling,Logistics and inventory optimisation strategies.
 
Fintan has previously worked in the IT industry and has extensive ERP experience consulting on Manufacturing/Production planning systems using BAAN, SAP & Oracle software systems.

Fintan Jordan

Horizon Therapeutics

Dr. Kaur is the Chair of The Cellular Therapy Coding and Labeling Advisory Group (CTCLAG). She is the Technical Director of the Cell Therapy lab at MD Anderson Cancer Center (MDACC), TX USA. The Lab is accredited by CAP, CLIA and FACT and registered with the FDA. She oversees the operations of the standard of care (SOC) Cell Therapy transplant Labs, GMP labs as well as the Externally sponsored trials (>115 clinical trials and most of them are genetically modified products for patient treatment) that are from various departments of MDACC. The GMP lab manufactures products for >25 Phase I/II Clinical trials that include Antigen specific T cells, Viral specific T cells, TILs, cord blood NK cells, Bone marrow and cord tissue MSCs, exosomes, genetically modified T cells and NK cells.

Indresh Kaur

MD Anderson Cancer Center

Professor Mickey BC Koh received his medical degree at the National University of Singapore followed by subsequent specialist Haematology training (FRCPath, MRCP and PhD) in London.

He holds several joint positions. Prof Koh is the Clinical Director of the Haematology, Renal and Oncology Departments at St George’s University Hospital, London, UK and part of Infection and Immunity Academic Group at St George’s Medical School. He is also the Programme/Medical Director of the Academic Cell/Gene Therapy Facility in Singapore involved in cell therapy trials across haemato-oncology and regenerative medicine.
 
Professor Koh has been appointed to the Expert Committee on Biological Standardisation at the World Health Organisation. He is the current Vice-President of the Worldwide Network for Blood and Marrow Transplantation (WBMT) and a past Board member of the International Society of Cellular Therapy (ISCT). He is also on the Board for ICCBBA and for the International Society of Blood Transfusion (ISBT).

Mickey BC Koh

St George's University Hospitals, London, UK and Health Sciences Authority, Singapore

Dr. Kuehnert serves on the ICCBBA board of directors as Treasurer. He is a Professor at Hackensack Meridian School of Medicine, and a fellow of the American College of Physicians and the Infectious Diseases Society of America. 

From 2003 to 2017, Dr. Kuehnert was Director of the Office of Blood, Organ, and Other Tissue Safety at the Centers for Disease Control and Prevention (CDC). From 2017 to 2021, he was medical director of MTF Biologics, a nonprofit tissue processor founded in 1987, where he is currently a consultant. He is deputy editor-in-chief of the journal Emerging Infectious Diseases, published by CDC. 

He completed his undergraduate education at the University of California at San Diego and received his medical degree from Columbia University’s College of Physicians & Surgeons. He trained in Internal Medicine at Stanford University and the University of California at San Francisco, and in Infectious Diseases at Emory University.

Matthew Kuehnert

ICCBBA Board

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development and is an author or co-author of over 125 publications. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in 2016, and is a Fellow of the American College of Physicians and a member of the National Academy of Medicine.

Peter Marks

FDA

MD, PhD. Researcher in biomedical sciences focused in gene and cell therapy, tissue and cell banking. Professor of Pharmacology of the School of Medicine at National University of México.

Head of the Skin and Tissue Bank at the National Institute of Rehabilitation of Mexico. President of the Latin American Association of Tissue Banks ALABAT.

Francisco Martinez

ALABAT

Dario Martino is a Patient Advocate actively representing patients with primary immunodeficiencies and other conditions requiring the use of blood components. Attending this event as a representative of the Italian Association for Primary Immunodeficiencies (AIP), he brings the perspective of an experienced patient, informed by years of personal use of blood components and collaboration with numerous patients across Italy.

Beyond his work with AIP, Dario is also involved in advocating for patients with transfusion-dependent thalassemias and hemoglobinopathies, leading an association and collaborating with the national federation UNITED.

His advocacy spans local, national, and international levels, focusing on outreach, testimony, non-profit projects, and consultancy. He mediates between patients, healthcare professionals, institutions, and stakeholders to raise awareness and improve the quality of life for those affected by these conditions.

With a scientific background, Dario is pursuing a degree in Biological Sciences at the University of Milan. Fluent in Italian, English, and French, he aims to offer a well-rounded, multidimensional perspective through his advocacy work.

Dario Martino

AIP - Primary Immunodeficiency Association (Italy)

Yuyun Siti Maryuningsih, Team Lead for Blood and Other Products of Human Origin, Health Products Policy and Standards Department, WHO Headquarters.

I am a Medical Doctor, with a master's degree in Virology, and a doctorate in Biomedical Sciences. Before working at the WHO, I worked for 21 years at the National Blood Center of the Indonesian Red Cross, and 4 years at the Ministry of Health of Indonesia in charge of the national blood program. From 2016-2019, I was a Regional Director of the International Society of Blood Transfusion (ISBT) for the South-East Asia Region, and from 2015-2017, I was a Chairperson of the Indonesian Association of Transfusion Medicine.

Yuyun Siti Maryuningsih

World Health Organization

TBD

Ana Menjívar

WHO-PAHO

Karen Moniz, MHA, MT(ASCP)SBB, is Technical Director at ICCBBA. She leads the technical development of the ISBT 128 Standard to meet the global traceability needs for medical products of human origin (MPHO). She studied medical technology at the University of Kentucky, immunohematology at Johns Hopkins Hospital, and healthcare administration at George Washington University. Karen spent decades managing blood donor centers, transfusion services, and biomedical information technology. An early advocate of the ISBT 128 Standard, she remains enthusiastic about the evolution of the ISBT 128 Standard to continue contributing to MPHO traceability, biovigilance, harmonization of terminology, and electronic data transfer.

Karen Moniz

ICCBBA

Graduated from Medical School at Autonomous University (UAB) in Barcelona 1997 and Certified Transplant Coordinator for ETCO in 1999. Two year Executive Master in Health Services Management, ESADE 2023. Associate professor University of Barcelona since 2018. Current PhD program student in UAB.

Ten years Organ and tissue donation in Clinic Hospital and 8 years TB medical director. Since 2015 medical vigilance officer in Catalan Transplant Organization and Notify project communication.

Training coordinator: International online tissue banking course (22 editions)

Advance face-to-face course on tissue and cell banking (12 editions)
OCATT-ONT Biovigilance course (8 editions). EDQM expert on tissue and cell guide for the quality and safety, for the strengthening on biovigilance programs and EDQM training course on quality management for TE. 32 scientific publications, 58 congress presentations and 3 book chapters.

Aurora Navarro

Catalan Transplant Organization

TBD

Vanja Nikolac-Markic

European Directorate for the Quality of Medicines

Agnieszka Nowak PhD, ESHRE Clinical Embryologist

Head of IVF laboratory in ARTVIMED Krakow, and assistant professor at Agriculture University in Krakow, Poland.
Current deputy of The Polish Society of Reproductive Medicine and Embryology (PTMRiE).

The member of ESHRE Embryology Training Centers Certification (ETCC) and the member of ESHRE Young Talent Group.

The member of ESHRE Committee of National Representatives 2023-2026

The main fields of interest are cryopreservation and in vitro maturation of oocytes and the incorporation of new technologies in the IVF laboratory.

Agnieszka Nowak

European Society of Human Reproduction and Embryology (ESHRE)
A results-driven Quality health care leader with 15+ years of proven professional experience leading multidisciplinary teams to excellence in quality care delivery, performance and process improvement, and patient experience. I've found my true home in Quality & Safety with a passion for inspiring system-based thinking and a multidisciplinary approach to creating scalable, repeatable, and innovative best practices.

Scott Olson

NMDP

She graduated with degree in Medicine and Surgery at the University of Bologna and had her scientific training for specialty degree in Microbiology and Virology at the University of Bologna.
 
Medical Doctor at the Operative Unit of Microbiology, IRCCS Sant’ Orsola University Hospital of Bologna, she focuses her interest on the diagnosis of infections in solid organ and hematopoietic stem cell transplant recipients.
 
Member of the EU Vigilance Expert Subgroup. Since 2016 she is a member of the CNT-WHO NOTIFY Project support group where she manages the clinical and scientific database content of the NOTIFY Library, an open access database of published didactic cases of adverse occurrences arising with the donation, processing or clinical application of Medical Products of Human Origin.

Evangelia Petrisli

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Dr. Pruett is a Professor of Surgery and Internal Medicine at the University of Minnesota. He has been in leadership roles for organ donation and transplantation for most of career; OPTN/UNOS President (2007-8), ASTS President (2016-17, has worked closely with PHS on biovigilance issues and risk assessments in deceased donation, with HRSA on OPTN issues and multiple other issues. He currently co-lead (with Scott Brubaker, FDA) an ACBTSA subcommittee on a gap analysis on US tissue biovigilance and tracking.

Dr. Pruett is trained in General Surgery and Internal Medicine, with subspecialty training/boards in Transplantation, Medical Infectious Diseases and Surgical Critical Care. He has spoken broadly on medical issues about organ donation and transplantation especially the recognition and treatment of diseases transmission through organ transplantation. In addition, he is involved with legal and system issues that impact organ transplantation and donation throughout global healthcare systems.

Timothy Pruett

University of Minnesota

MD Degree University of Rome. Specialty in Hematology, Specialty in Immunohaematology. Post-doc in Transfusion medicine. Post-doc Master on Quality and quality system in the blood establishments. Qualification as Auditor of Healthcare Services CERMET (Certification and Research for Quality. Director of Medical Affairs & Blood Inspection Systems, at the Centro Nazionale Sangue (CNS), National Institute of Health (ISS, Istituto Superiore di Sanità). Member of the Inspection expert subgroup (IES) and Vigilance expert subgroup (VES) of the European Commission. Project coordinator of several European projects and JA in the field of oversight activities of SoHO establishments. Full competence in all regulatory issues ruled by national and European legislation on blood, blood components, cord blood and haematopoietic stem cells (HSC). Solid competence in quality system management and auditing of quality system in health care services, blood and tissue establishment and HSC transplantation programmes.

Simonetta Pupella

National Blood Centre (CNS)

My name is Dea Svaneby. I am 47 years old, married and have three adult children. I finished medical school in 2006 and started my specialist training in clinical genetics in 2009. I have worked with genetics in public hospitals in Denmark since 2009.

I started working at Cryos 4 years ago and do my best to ensure the genetic and medical quality of our donor gametes for our customers.

I work with the donor evaluation and approval process, handling reported conditions in relation to donor conceived children, have responsibility for the genetic evaluation and matching, and ensure medical quality.

Dea Svaneby

Cryos

I am a professor of pathology and laboratory medicine and of medicine at Geisel School of Medicine at Dartmouth in Hanover, NH, USA. I was trained in Warsaw, Poland and Boston, Massachusetts. I have been involved in transfusion medicine, apheresis, and cellular therapy since mid-1990s. I have had a privilege to work for the last 15 yeas with ICCBBA in different positions including being a chair of CTCLAG and currently the chair of its Board of Directors. I strongly believe that safety of our patients and donors worldwide can be continuously improved by appropriate use of technology in tracking and tracing of MPHOs from their origin to administration. I am looking forward to Forum 30 as a great opportunity to bring together thoughts and ideas from participants coming from many corners of the world with a variety of perspectives.

Zbigniew Szczepiorkowski

Dartmouth Hitchcock Medical Center

My background is in the field of proteomics where I obtained a PhD in biomarker research in inflammatory arthritides at the University of Ghent in 2007. At that time, I combined my scientific enthusiasm with the responsibility of quality manager for an accredited DNA fingerprinting laboratory. I started a at the department for reproductive medicine in 2009 where I combined quality management with project and laboratory process management and research in fertility preservation. Currently, I am responsible for the operational management of the IVF laboratory of the Ghent University Hospital IVF lab, where I have the privilege to work with a very dynamic and enthusiastic team. I am the past-coordinator of the special interest group SQART at ESHRE, Belgian representative for EDQM at the Council of Europe and board member of international organization ICCBBA (ISBT-128).

Kelly Tilleman

Ghent University Hospital

Born on 14th August 1987 in Treviso, Italy

Education
2013 Professional National Register in Biology
2009-2011 Specialistic University Degree in Medical Biology University of Padova, Main topics: Pathology, Microbiology, Genetics, Anatomy, Histology
2006-2009 Degree in Biology, University of Padova Main topics: Chemistry, Physyology, Evolution, Biochemistry, Biology

Professional Experience
August 2018 – Present Director of Fondazione Banca dei Tessuti del Veneto, Responsible Person for all tissue bank activities
2013- July 2018 Quality Manager and Research activities, Fondazione Banca dei Tessuti del Veneto, Main activities:
2010-2011 RESEARCHER activities Universitè Pierre et Marie Curie – Hopital Saint Antoine (Paris)

Diletta Trojan

FBTV

Physician, doctor of medical sciences; academic teacher, assistant professor at the Medical University of Warsaw; deputy director for medical affairs of the National Center for Tissue and Cell Banking; member of the National Transplantation Council of the Minister of Health; expert on ISBT 128 standard in Poland; member of the Technical Advisory Groups of the ICCBBA; speaker at national and international training courses and conferences on tissue and cell banking; author of numerous publications on the above topics.

Izabela Uhrynowska-Tyszkiewicz

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Dr. Joaquim Vives is a highly accomplished biochemist with a PhD in Biochemistry from Universitat Autònoma de Barcelona (UAB) and extensive experience in both private and academic biotech sectors. He has specialized in optimizing cellular processes for the production of diagnostic and therapeutic molecules and developing cell manufacturing methods for drug screening and therapy. His career includes significant roles at the University of Edinburgh, Stem Cell Sciences Ltd., and Banc de Sang i Teixits in Barcelona, where he leads research on Advanced Therapy Medicinal Products. Dr. Vives has published over 70 articles, holds three patents, and has supervised eight PhD students. He is also associated with Vall d'Hebron Institut de Recerca and coordinates a Master Programme in Transfusion Medicine at UAB Faculty of Medicine. He is actively involved in scientific communication and has held leadership roles in several scientific societies.

Joaquim Vives

Banc De Sang | Teixits

Johanna (Jo) Wiersum, née Osselton, MD, PhD, is a partly retired specialist in community medicine, working in a training and advisory capacity in blood donor medicine and in hemovigilance and biovigilance in The Netherlands. Over the years she has actively participated in the International Haemovigilance Network, the EU Vigilance Expert Subgroup of the Competent Authorities for Blood, Tissues and Cells, the ISBT haemovigilance working party and WHO. Her key focus in these groups is on efforts to harmonise definitions and to strengthen vigilance systems for substances of human origin.

Johanna Wiersum

TRIP National Hemovigilance and Biovigilance Office

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Forum 25 in Review