17th PIC/S EXPERT CIRCLE ON HUMAN BLOOD AND TISSUE
Update on international activities and training courses and workshops
September 28th to October 1st, 2010
Monday September 27th, 2010
16h00 - 17h00
18h30 - 20h00 |
Steering Committee Pre-Meeting
Welcome Cocktail at the Timhotel Opéra Madeleine |
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Tuesday September 28th, 201
9H00-9h30
9H30-10H00
10h00-13h00
10h00-10h20
10h20-10h40
10h40-11h00
11h00-11h20
11h20-11h40
11h40-12h00
12h00-12h20
12h20-12h40
13h00-14h30
14h30 – 17h30
14h30-14h50
14h50-15h10
15h10-15h30
15h30-15h45
15h45-16h05
16h05-16h25
16h25-16h45
16h45-17h05
17h05-17h25
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Registration
Session A
Welcome & Introduction
Session B (moderator : Jean-Marc Spieser)
BLOOD
Council of Europe: Guide to the preparation, use and quality assurance
of blood component
EUBIS: Achievements of the project
TISSUES
American Association of Tissue Bank (AATB):
Accreditation versus inspection of tissue establishments
Coffee break
Council of Europe : Trafficking in organs, tissues and cells - joint council
of Europe united nations study
WHO : The Guiding Principles of 2009
US FDA : Current US Situation on Inspections and Enforcement for Human
Tissue
PMDA Japan: Inspection results in Japan
Lunch
Session C
CELLS
French Biomedicine Agency: Cord blood for autologous use: An issue
for competent authorities
Health Science Authority Singapore : Human Cell & Tissue-based Therapeutic Products Regulations in Singapore
French Biomedicine Agency: Vigilance on ART
Coffee break
MISCELLANEOUS
European commission : latest development related to human substances
IAEA: Key elements of inspection of irradiation facilities and processes
ISO: The development of ISO standards
ISO: Application of risk management to viable material of human origin
used for the production of medicinal products (a new ISO norm)
PIC/S: The PIC/S Aide Memoire on Inspection of Testing Laboratories
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Susanne Douglas TGA (Chairman of the PICS)
Marie-Emmanuelle
Behr-Gross
Chritian Seidl
Scott Brubaker
Aysegül Elveris
Luc Noel
Mary A. Malarkey
Tsuguo Sasaki
Catherine Faucher
Goh Choon Wee
Anne Pariente
Stefaan Van Der Spiegel
Jan Wondergem
Gabrielle Troescher
Sabine Kloth
Patrick Costello
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Wednesday September 29th, 2010
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9H00- 12h45
12h45-13h45
13h45-17h30 |
Session D
Inspector Training extracts from the
Eustite project training course
Tutors : Deirdre Fehily and Margarida Amil Facilitators : Artur Kaminsky, Susanne Douglas,Fewzi Teskrat and Fernando Figueira
Part 1 : workshops
1. Four case studies : 1, 2, 3, 4
--> Attendees split in 4 discussion groups
2. Plenary session
--> Sharing of results and key conclusions for the four case
studies
Lunch
Session E
Part 2 : role plays
3 role plays
Methodology: During each role play, players will be in 2 groups (3 person
per group, inspectors and inspectees) . All other participants will actively
record observations.
Face to face discussion on each topic addressed in the role plays.
Plenary session for discussion on each role play. |
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Thurday September 30th, 2010
9H00-12h15
12h15-13h15
13h15-17h00
19H00-00h00
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Session F
Technical communication and Workshop
Tutors : Michel Combet (MC+) and Philippe Duheim (Interteck)
Facilitators : Patrick Costello, Diane Maloney and Susanne Douglas
Part 1: Technical communication
- Key issues for Qualification and Validation, General methodology and documentation
- Key issues for HVAC system (Heating, Ventilating and Air Conditioning) and introduction to ISO 14 644 standards.
- Key issues for the test of thermostatic chamber and cryogenic system
Lunch
Session G
Part 2: Workshop
Objective: As an application of the part 1, the objective is to build practical
tools for Qualification file evaluation for equipments and HVAC system.
Methodology : Attendees will be split in working groups.
Sharing of results and conclusions for each subject
Social event : dinner at the “Musée d’Orsay”- Orsay Museum in Paris
19h00-21h00: Free visit of the museum
21h15: Dinner |
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Friday October 1st, 2010
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9h30 – 12h30
9h30-9h45
9h45-10h45
10h45-11h00
11h00-11h20
11h20-11h40
11h40-12h00
12h00-12h20
12h20-12h40
12h40-13h00
13h00-13h15
13h15-14h30
14h30-16h30 |
Session H
(moderator : Susanne Douglas & Scott Brubaker)
Speech of General Director
Presentation of the outcome of the day 3 workshop in plenary session
- Checklist for HVAC System
- Checklist for thermostatic chamber
Coffee break
ATMP: From research to the marketing authorization
ASST : results of the cooperation between ASST and Afssaps in the
inspection field
SOHO V&S project (new EU project): Vigilance and Surveillance of Substances of Human Origin
Afssaps: Preliminary results on the survey on fraudulent and illegal
activities for tissues and cells
ANVISA: Brazilian regulation on blood, cell, tissues and organ-inspection
and risk evaluation's approach
Conclusion of the 17th session of the Expert Circle
Presentation of the Next PIC/S meeting in Estonia
Lunch
Steering Committee Post-Meeting
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Jean Marimbert (General Director of Afssaps)
Michel Combet and Philippe Duhem
Odile Damour and Ayumi Murayama
Margarida Amil
Deirdre Fehily and Fewzi Teskrat
Frances Delaney
Christiane da Silva Costa
Susanne Douglas
Svetlana Orlova (Estonian State Agency of Medecines)
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