Workshop on Plasma Management in Eastern Europe and Nearby Countries 12-14 November 2026, Kalyon Hotel, Istanbul

PROVISIONAL WORKSHOP PROGRAM

DAY 1: THURSDAY, 12 NOVEMBER 2026

08:30 – 09:00 Registration

09:00 – 10:00 I. Introductory session

09:00 – 9:10 Welcoming statements from ISBT and WHO

09:10 – 09:25 Concept of a regional approach to advance utilization of domestic plasma to provide safe plasma proteins

09:25 – 09:30 Goals for the workshop

09:30 – 09:40 Remarks from the Republic of Türkiye Ministry of Health

09:40 – 10:00 Keynote addresses • Clinical importance of essential PDMPs • Global Insufficiency of PDMPs

10:00 – 10:30 Coffee / Tea Break

10:30 – 11:00 II. International Perspective on Patient Access to PDMPs

• Optimal utilization of plasma as part of public health • Concepts of national and regional self-sufficiency in PDMPs • Model of emerging plasma cooperation in Western Europe

11:00 – 12:30 III. Review of Survey Responses

• Analysis of “landscaping” survey and pre-workshop questionnaire with use of the

PESTELE framework • Open discussion

12:30 – 13:30 Lunch Break

13:30 – 15:30 IV. Selected Country Presentations on Progress Towards Plasma Fractionation

13:30 – 14:15 • Self-sufficient and functional settings

14:15 – 15:00 • Partial and developing settings

15:00 – 15:30 • Open discussion

Workshop on Plasma Management in Eastern Europe and Nearby Countries 12-14 November 2026, Kalyon Hotel, Istanbul

15:30 – 16:00 Coffee/Tea Break

16:00 – 16:30 V. Panel Discussion on Pathways from Plasma Collection to PDMPs

• Round table discussion

16:30 – 17:30 VI. Q/A and General Discussion

• Q/A with speakers and panelists • Reflection on the survey findings and use of the PESTELE framework • Open discussion

DAY 2: FRIDAY, 13 NOVEMBER 2026

09:00 – 10:30 VII. Standards for Plasma Collection and Quality Control

• Plasma Collection Methods and Quality Assurance −Whole blood separation versus plasmapheresis −Protections for donor health and safety

• Documentation, traceability, and quality control during handling, storage, and transport

10:30 – 11:00 Coffee/Tea Break

11:00 – 12:30 VIII. Technologies and Viral Safety Measures for Plasma Fractionation

11.00 – 11:45 • Common fractionation methods (Cohn fractionation, chromatographic methods)

11:45 – 12:30

• The Safety Tripod for PDMPs −Donor Selection

* Viral testing of donations and plasma hold periods * Viral testing of plasma pools * Robust virus inactivation and removal technologies

−Lessons learned from 10 years of failures and 25 years of success

12:30 – 13:30 Lunch Break

Workshop on Plasma Management in Eastern Europe and Nearby Countries 12-14 November 2026, Kalyon Hotel, Istanbul

13:30 – 15:30 IX. GMP Standards and Quality Control

13:30 – 14:30

• GMP Compliance Essentials for Plasma Fractionation

−Key GMP requirements for production facilities

−Process validation, environmental monitoring, and documentation

14:30 – 15:30 • Quality Control Measures and Analytical Methods: Physicochemical

characterization, purity, potency, and stability testing

15:30 – 16:00 Coffee/Tea Break

16:00 – 17:00 X. Adapting large-scale fractionation processes to stepwise intermediate scale approaches to optimize plasma usage into safe plasma proteins

16:00 – 16:20 • Options for preparation of fibrinogen and normal immune globulin and strategies for

preparation of hyperimmune globulins including donor immunization

16:20 – 16:40 • Production of anti-RhD Immune Globulins

16:40 – 17:00 • Preparation of hyperimmune globulins for COVID-19

17:00 – 17:30 XI. Q/A and Open Discussion

DAY 3: SATURDAY, 13 NOVEMBER 2026

09:00 - 10:30 XII. Facility Registration and Regulatory Requirements

09:00 – 09:45

• Facility registration and product market authorization −International regulatory frameworks and harmonization efforts

* WHO GBT Plus Blood • Overview of regulatory requirements for PDMPs

09:45 – 10:30 • Preparing a Plasma Master File: comprehensive product registration dossiers,

including documentation and clinical research considerations

10:30 – 11:00 Coffee/Tea Break

Workshop on Plasma Management in Eastern Europe and Nearby Countries 12-14 November 2026, Kalyon Hotel, Istanbul

11:00 – 12:30 XIII. SWOT Analysis on Progress Towards Fractionation

• Facilitated SWOT analysis • Open discussion

12:30 – 13:30 Lunch Break

13:30 – 15:00 XIV. Key Elements for Development of a Common Roadmap

13:30 – 14:15

• National development −MoH engagement −Plasma policy and plan−Regulatory framework −Infrastructure Investment −Sustainable support −Movement towards Contract Plasma Fractionation

14:15 – 15:00

• Opportunities for regional cooperation −Adoption of common plasma standards −Mutual regulatory recognition −Possibility of plasma pooling

15:00 – 15:30 Coffee/Tea Break

15:30 – 16:30 XV. Possible Next Steps:

• General discussion • Request for volunteers to develop draft document

16:30 – 17:00 Closure of the meeting and Group Photograph

Workshop on Plasma Management in Eastern Europe and Nearby Countries 12-14 November 2026, Kalyon Hotel, Istanbul

PROVISIONAL WORKSHOP PROGRAM

DAY 1: THURSDAY, 12 NOVEMBER 2026

08:30 – 09:00 Registration

09:00 – 10:00 I. Introductory session

09:00 – 9:10 Welcoming statements from ISBT and WHO

09:10 – 09:25 Concept of a regional approach to advance utilization of domestic plasma to provide safe plasma proteins

09:25 – 09:30 Goals for the workshop

09:30 – 09:40 Remarks from the Republic of Türkiye Ministry of Health

09:40 – 10:00 Keynote addresses • Clinical importance of essential PDMPs • Global Insufficiency of PDMPs

10:00 – 10:30 Coffee / Tea Break

10:30 – 11:00 II. International Perspective on Patient Access to PDMPs

• Optimal utilization of plasma as part of public health • Concepts of national and regional self-sufficiency in PDMPs • Model of emerging plasma cooperation in Western Europe

11:00 – 12:30 III. Review of Survey Responses

• Analysis of “landscaping” survey and pre-workshop questionnaire with use of the

PESTELE framework • Open discussion

12:30 – 13:30 Lunch Break

13:30 – 15:30 IV. Selected Country Presentations on Progress Towards Plasma Fractionation

13:30 – 14:15 • Self-sufficient and functional settings

14:15 – 15:00 • Partial and developing settings

15:00 – 15:30 • Open discussion

Workshop on Plasma Management in Eastern Europe and Nearby Countries 12-14 November 2026, Kalyon Hotel, Istanbul

15:30 – 16:00 Coffee/Tea Break

16:00 – 16:30 V. Panel Discussion on Pathways from Plasma Collection to PDMPs

• Round table discussion

16:30 – 17:30 VI. Q/A and General Discussion

• Q/A with speakers and panelists • Reflection on the survey findings and use of the PESTELE framework • Open discussion

DAY 2: FRIDAY, 13 NOVEMBER 2026

09:00 – 10:30 VII. Standards for Plasma Collection and Quality Control

• Plasma Collection Methods and Quality Assurance −Whole blood separation versus plasmapheresis −Protections for donor health and safety

• Documentation, traceability, and quality control during handling, storage, and transport

10:30 – 11:00 Coffee/Tea Break

11:00 – 12:30 VIII. Technologies and Viral Safety Measures for Plasma Fractionation

11.00 – 11:45 • Common fractionation methods (Cohn fractionation, chromatographic methods)

11:45 – 12:30

• The Safety Tripod for PDMPs −Donor Selection

* Viral testing of donations and plasma hold periods * Viral testing of plasma pools * Robust virus inactivation and removal technologies

−Lessons learned from 10 years of failures and 25 years of success

12:30 – 13:30 Lunch Break

Workshop on Plasma Management in Eastern Europe and Nearby Countries 12-14 November 2026, Kalyon Hotel, Istanbul

13:30 – 15:30 IX. GMP Standards and Quality Control

13:30 – 14:30

• GMP Compliance Essentials for Plasma Fractionation

−Key GMP requirements for production facilities

−Process validation, environmental monitoring, and documentation

14:30 – 15:30 • Quality Control Measures and Analytical Methods: Physicochemical

characterization, purity, potency, and stability testing

15:30 – 16:00 Coffee/Tea Break

16:00 – 17:00 X. Adapting large-scale fractionation processes to stepwise intermediate scale approaches to optimize plasma usage into safe plasma proteins

16:00 – 16:20 • Options for preparation of fibrinogen and normal immune globulin and strategies for

preparation of hyperimmune globulins including donor immunization

16:20 – 16:40 • Production of anti-RhD Immune Globulins

16:40 – 17:00 • Preparation of hyperimmune globulins for COVID-19

17:00 – 17:30 XI. Q/A and Open Discussion

DAY 3: SATURDAY, 13 NOVEMBER 2026

09:00 - 10:30 XII. Facility Registration and Regulatory Requirements

09:00 – 09:45

• Facility registration and product market authorization −International regulatory frameworks and harmonization efforts

* WHO GBT Plus Blood • Overview of regulatory requirements for PDMPs

09:45 – 10:30 • Preparing a Plasma Master File: comprehensive product registration dossiers,

including documentation and clinical research considerations

10:30 – 11:00 Coffee/Tea Break

Workshop on Plasma Management in Eastern Europe and Nearby Countries 12-14 November 2026, Kalyon Hotel, Istanbul

11:00 – 12:30 XIII. SWOT Analysis on Progress Towards Fractionation

• Facilitated SWOT analysis • Open discussion

12:30 – 13:30 Lunch Break

13:30 – 15:00 XIV. Key Elements for Development of a Common Roadmap

13:30 – 14:15

• National development −MoH engagement −Plasma policy and plan−Regulatory framework −Infrastructure Investment −Sustainable support −Movement towards Contract Plasma Fractionation

14:15 – 15:00

• Opportunities for regional cooperation −Adoption of common plasma standards −Mutual regulatory recognition −Possibility of plasma pooling

15:00 – 15:30 Coffee/Tea Break

15:30 – 16:30 XV. Possible Next Steps:

• General discussion • Request for volunteers to develop draft document

16:30 – 17:00 Closure of the meeting and Group Photograph