Human Blood, Tissues, Cells & ATMPs

The PIC/S Expert Circle on Human Blood, Tissues, Cells & ATMPs was established in 1994. It has been very active in the training of Inspectors in the field of blood, blood components, plasma derivatives, cells (e.g. hematopoetic or myelopoetic progenitor cells) and tissues (e.g. skin, cartilage, bone, heart valves, etc.). ATMPs were added to its remit in 2015. The Expert Circle has also developed a number of PIC/S guidance documents. 

                                

Chairperson of the PIC/S Expert Circle on Blood, Tissue, Cells and ATMPs: Marisa Delbò (Italy / AIFA)

Key Features

The goals of the Expert Circle on PIC/S Expert Circle on Human Blood, Tissues, Cells & ATMPs are to:
 

  • hold experts' discussions and training of Inspectors in the field of blood, blood components, plasma derivatives, cells (e.g. hematopoetic or myelopoetic progenitor cells) and tissues (e.g. skin, cartilage, bone, heart valves, etc.) with particular focus on Advanced Therapies Medicinal Products (ATMPs);
  • finalise guidelines and aide memoires developed by the previous Expert Circle and develop guidelines and aide memoires on new topics such as ATMPs (including the elaboration of harmonised technical terms) in co-operation with the Working Group on the Aide Memoire on ATMPs;
  • map competences of PIC/S Participating Authorities with particular focus on the inspection of products manufactured in the field human blood, tissues and cells (including ATMPs).

Guidance Documents

A number of guidance documents have been developed by the Expert Circle on Human Blood, Tissues, Cells & ATMPs which are publicly available under "Publications".

Past Meetings

Seoul | Korea (Republic of)  2017
Hong Kong | Hong Kong SAR  2016
Rome | Italy 2015
Chinese Taipei | Taipei 2013
Singapore | Singapore 2012
Tallin | Estonia 2011
Saint-Denis | France 2010
Copenhagen | Denmark 2009
Melbourne | Australia 2008
Dublin | Ireland 2007
Utrecht | Netherlands 2006
Ottawa | Canada 2005
Langen | Germany 2004
Visegrad | Hungary 2003
Saint-Denis | France 2002
Stockholm | Sweden 2001
Saariselkä | Finland 2000
Interlaken | Switzerland 1998
Brunn am Gebirge | Austria 1997
Canberra | Australia 1996
Copenhagen | Denmark 1995
Langen | Germany 1994
 

Upcoming Meetings

Expert Circle meetings and training activities are only open to inspectors from PIC/S Participating Authorities, (Pre-)Applicants, Partners and Non-Member National Medicines Regulatory Authorities. The events are not open to Industry.

Upcoming meetings and training activities are announced under Calendar.

Training Materials

Expert Circle meeting materials are available under Materials. Login is required.