ipfa asia pacific workshop on plasma quality and … 2016/taipei 2016/ipfa_workshop_on... · plasma...

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taipei In collaboration with National Serology Reference Laboratory (NRL) Taipei Medical University (TMU) 8-9 March 2016 Taipei Medical University, Taipei, Taiwan Plasma Quality and Supply IPFA ASIA PACIFIC WORKSHOP ON Technological, regulatory and organisational tools to produce plasma for fractionation The International Plasma Fractionation Association (IPFA), National Serology Reference Laboratory, Australia (NRL) and Taipei Medical University (TMU) are pleased to announce the IPFA Asia Pacific Workshop on Plasma Quality and Supply. A Comprehensive Range of Topics This Workshop will identify and discuss key issues, strategies and opportunities to meet the increasing requirements for Plasma for Fractionation and essential plasma derived Medicinal Products in the Asia Pacific region. Hosted by Taipei Medical University (TMU), a comprehensive range of topics will be addressed including: Donor recruitment and selection Screening for blood borne pathogens, and its quality assurance GMP and Quality management for Plasma for Fractionation • Regulatory requirements Plasma fractionation options Clinical use of Plasma Derivatives Product manufacture and supply strategies information: [email protected]; tel. +31 20 512 35 61 This workshop will build on IPFA’s not-for-profit traditions and will encourage open and inclusive discussions between all stakeholders who may have an interest in and/or responsibility for developing technological, quality, regulatory and organisational tools to produce plasma for fractionation in the Asia Pacific region. We warmly invite you to attend this meeting and look forward to welcoming you to Taipei for this important event. Dr Paul Strengers, President IPFA Ms Susan Best, Director NRL Prof. Thierry Burnouf, Director Graduate Institute of Biomedical Materials and Tissue Engineering, TMU Who should attend? The Workshop is being developed by internationally recognised experts and will be of interest to colleagues with an involvement in policies to secure the supply of high quality plasma from the region to meet incre- asing patient needs for essential plasma derivatives. These will include delegates from: • Blood establishments • Haematologists, clinicians and medical students • Patient and donor organisations • Supporting industries • Regulatory authorities • Health Ministries and Agencies Event details | Registration | Sponsorship www.ipfa.nl • [email protected] • T +31 20 512 35 61 The registration fee is EURO 200 to encourage attendance by all stakeholders! @IPFAevents #ipfataipei

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Page 1: IPFA ASIA PACIFIC WORKSHOP ON Plasma Quality and … 2016/Taipei 2016/IPFA_Workshop_on... · Plasma Quality and Supply IPFA ASIA PACIFIC WORKSHOP ON Technological, regulatory and

taipeiIn collaboration with National Serology Reference Laboratory (NRL)Taipei Medical University (TMU)

8-9 March 2016 Taipei Medical University, Taipei, Taiwan

Plasma Quality and Supply

IPFA ASIA PACIFIC WORKSHOP ON

Technological, regulatory and organisational tools to produce plasma for fractionation

The International Plasma Fractionation Association (IPFA), National Serology Reference Laboratory, Australia (NRL) and Taipei Medical University (TMU) are pleased to announce the IPFA Asia Pacific Workshop on Plasma Quality and Supply.

A Comprehensive Range of Topics This Workshop will identify and discuss key issues, strategies and opportunities to meet the increasing requirements for Plasma for Fractionation and essential plasma derived Medicinal Products in the Asia Pacific region. Hosted by Taipei Medical University (TMU), a comprehensive range of topics will be addressed including:• Donor recruitment and selection• Screening for blood borne pathogens, and its quality assurance• GMP and Quality management for Plasma for Fractionation• Regulatory requirements• Plasma fractionation options• Clinical use of Plasma Derivatives• Product manufacture and supply strategies

• Event details | Registration | Sponsorship

For event details, registration and sponsorship opportunities please visit www.ipfa.nl. You may

also contact the IPFA Secretariat for further information: [email protected]; tel. +31 20 512 35 61

This workshop will build on IPFA’s not-for-profit traditions and will encourage open and inclusive discussions between all stakeholders who may have an interest in and/or responsibility for developing technological, quality, regulatory and organisational tools to produce plasma for fractionation in the Asia Pacific region.

We warmly invite you to attend this meeting and look forward to welcoming you to Taipei for this important event.

Dr Paul Strengers, President IPFAMs Susan Best, Director NRLProf. Thierry Burnouf, Director Graduate Institute of Biomedical Materials and Tissue Engineering, TMU

Who should attend?The Workshop is being developed by internationally recognised experts and will be of interest to colleagues with an involvement in policies to secure the supply of high quality plasma from the region to meet incre-asing patient needs for essential plasma derivatives. These will include delegates from:

• Blood establishments• Haematologists, clinicians and medical students • Patient and donor organisations• Supporting industries• Regulatory authorities• Health Ministries and Agencies

Event details | Registration | Sponsorship

www.ipfa.nl • [email protected] • T +31 20 512 35 61

The registration fee is EURO 200 to encourage attendance by all stakeholders!

@IPFAevents#ipfataipei

Page 2: IPFA ASIA PACIFIC WORKSHOP ON Plasma Quality and … 2016/Taipei 2016/IPFA_Workshop_on... · Plasma Quality and Supply IPFA ASIA PACIFIC WORKSHOP ON Technological, regulatory and

Session 1: OPENING AND INTRODUCTION • Formal Opening • TMU – Welcome and Introduction • IPFA – Setting the Scene/Clinical Uses of Plasma Products • NRL – Role of NRL • Keynote – Organisation of Blood/Plasma Collection in the Region

Session 2: MEETING PATIENT NEEDS • Unmet needs for plasma products – the patients’ perspective • Patient Programmes in South East Asia • Diagnostic Programmes • Managing clinical use of blood and plasma components Session 3: QUALITY MANAGEMENT IN BLOOD BANKING • What is Quality management? • Processing and validation • Quality Indicators • Auditing, self-inspection and accreditation

Session 4: SCREENING PROGRAMMES • Transfusion transmissible pathogens relevant to the region • Donor screening in the Region • Panel Presentations and Discussion

WORKSHOP DINNER

Session 5: MANUFACTURERS’ SESSION • GFE Blut • Asahi Kasei Medical Co, Ltd. • Others to follow

Session 6: DONOR RECRUITMENT AND SELECTION • Donor recruitment and social marketing • Milestones and results of the VNRD programme in Taiwan • National blood collection programmes

Session 7: REGULATORY CONSIDERATIONS • WHO requirements for PFF for contract and domestic fractionation programmes • Benefits of Plasma quality programmes in Blood Establishments • Regulatory experiences in South East Asia / Pacific • National Accreditation programmes

Session 8: REQUIREMENTS FOR EFFECTIVE PROGRAMMES TO ACHIEVE STRATEGIC INDEPENDENCE IN PLASMA PRODUCT SUPPLY • Goals and value of Strategic Independence • WHO Initiatives • Experiences of national Blood Transfusion Establishments

Workshop programme OutlineD

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