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Deliverables Produced

D.8.1 - CATALOGUE OF EXISTING CLINICAL DATA APPROPRIATE TO PROVIDE INFORMATION ON THE
QUALITY AND SAFETY OF HUMAN BLOOD, CELL, AND TISSUE THERAPEUTICS ONCE APPLIED TO PATIENTS,
UNDER THE CONDITIONS OF CURRENT STATE-OF-THE-ART PROCESSING AND TESTING PROTOCOLS. (Oct
2019)

D.8.2 - CATALOGUE OF RISK-BASED SET OF CRITERIA, APPROPRIATE TO EVALUATE THE ESTABLISHED
CATALOGUE OF CLINICAL DATA FOR COMPLETENESS AND SUITABILITY IN CASE OF INTRODUCTION OF
INNOVATION TO THE CURRENT PROCESSING AND TESTING PROTOCOLS FOR HUMAN BLOOD, CELL, AND
TISSUE THERAPEUTICS. (Dec 2019)

D.9.1 - INTGRATED DATA MODEL (Oct 2020)

D.8.3. - TECHNICAL ANNEX 3 TO OVERALL GUIDANCE: ASSESSING CLINICAL DATA AS PART OF PREPARATION
PROCESS AUTHORISATION (PPA) (Oct 2020)

D.7.1. - TECHNICAL ANNEX 2 TO OVERALL GUIDANCE: ASSESSING THE QUALITY AND SAFETY OF DONOR TESTING,
PATHOGEN REDUCTION AND STERILISATION STEPS AS PART OF PREPARATION PROCESS AUTHORISATION (PPA)
(November 2020 - External Advisory Board evaluation)

D.5.1. - EXTENSION OF THE OUTPUTS OF PREVIUOS PROJECTS, VISTART WP5-B, EUROGTP-II, ECCTR, TO BE
APPLICABLE TO BLOOD ESTABLISHMENTS (Aug 2020 - DRAFT - Final Comments)

D.5.2. - REPORT ON THE OUTCOME AND CONCLUSIONS OF THE SURVEY, DESK-BASED REVIEW OF PREPARATION
PROCESS AUTHORISATIONS IN OTHER FIELDS AND THE MULTI-COUNTRY WORKSHOP (Aug 2020 – DRAFT – Final
Comments)

This brochure is part of the joint action ‘785269/GAPP’ which has received funding from the European Union’s 17
Health Programme (2014-2020) GAPP - Newsletter3