Vistart

Livia Cannata: Presentation on VISTART at the Meeting of the Competent Authorities for Blood and Blood Components - 13 -14 April 2016 in Brussels

Simonetta Pupella will take a presentation on VISTART at Congress of the Italian Society of Transfusion Medicine and Immunhaematology (SIMTI) in Bologna on May 25-28,2016.

It is a very useful link!

file:///H:/My%20Documents/GroupWise/FDA%20Guide%20to%20Inspections%20of%20Blood%20Banks%20-%20BloodBook,%20Blood%20Information%20for%20Life_2.html

 Useful links

http://www.ipst.pt/index.php/haemovigilance,

 http://www.ipst.pt/index.php/biovigilance,

Final agenda

VISTART Final Meeting Agenda – Lisbon 21st and 22nd April 2016

21/04/2016 Day 1, morning session – 9h00 to 13h00

1. Welcome and Opening; 30 minutes; Gracinda de Sousa (Board of the Portuguese Blood and Transplantation Institute)

2. VISTART developments since October 2015; 30 minutes (to be announced))

a. Discussion 10 minutes

3. Strategy to achieve harmonization in SARE/SAE reporting for blood, tissues cells and assisted reproduction.

a. Revision of the EU directives and Common Approach; 45 minutes, Jorge Condeço

b. Discussion 20 minutes

Coffee break; 30 minutes

c. Comparative analysis, main outcomes, achievements and limitations; 30 minutes; Maria Antónia Escoval

d. SARE reporting. Analysis of results; 20 minutes; Giuseppina Facco

e. Discussion 20 minutes

Lunch

21/04/2016 Day 1, afternoon session – 14h00 to 17h00

4. Strategy to achieve harmonization in RAB/RATC reporting for blood, tissues cells, and assisted reproduction

a. Comparative analysis, convergent points and main outcomes, 30 minutes, Giuseppina Facco

b. Discussion – 20 minutes

Coffee Break; 30 minutes

5. Harmonized recommendations for the management of SARE/SAE and RAB/RATC, 30 minutes

22/04/2016 Day 2, morning session – 9h00 to 12h30

1. ​What is the Notify Project? Aims and main components; 30 min, Daniela Minutoli

Notify Library content: classification and analysis of the different types of adverse occurrences associated with the clinical application of SoHOs; 30 min, Evi Petrilisi
Coffee Break, 30 minutes

Risk assessment through selected case examples directly from the Notify Library 30 min, Giuseppina Facco
Criteria for selection and analysis of case types of didactic value for insertion in the Notify Library by CAs 30 min, Evi Petrilisi
Discussion, proposal; 30 minutes
Lunch

22/04/2016 Day 2, afternoon session - 14h00 to 15h30

Are Biovigilance and Haemovigilance in the same development level?
a. Survey Presentation and discussion - haemoviglance; 30 minutes; Jorge Condeço;

b. Survey presentation and discussion - biovigilance : 30 minutes;: Ana Rita Laranjeira

Next steps/Next meeting: date, agenda, and localization; 30 minutes
Closure

Waiting to see you soon in Lisbon

Have a nice travel

Com os melhores cumprimentos/Best wishes

Jorge Condeço | Director Ténico do CSTP

WP10 participation at the 42^nd EBMT annual meeting with Workshop (Spotlight Session: “Info on Single Europen Code”) and booth n. 509 in the Exhibition Area (https://b-com.mci-group.com/EventProgramme/EBMT2016.aspx)