ICG annexe1

As early as October 2013, at the final round table of the A3P international congress in Biarritz, A3P became interested in the revision of Appendix 1. A GIC was set up early 2014 by a dozen experts extended to 20 below after a motivated call to participation and specify its objectives at its first meeting on January 7 2014:

- specify the principles, guidelines and main chapters that the new version should contain,
- indicate specific points requiring corrections, additional explanations,
or deletion,

- to introduce additional points brought by, among other things, new technologies and therapies.

The numerous exchanges and meetings, as well as the round table with interactive vote during the last A3P international congress in October 2014, led to the sending of a response to the Concept Paper EMA / PICS for the revision of the Annex. 1 2 February 2015 containing about fifteen general comments published in the 46 issue of The Wave and about 120 specific comments that will be summarized in 57 proposals in the following 47 number. These general comments have been taken up in full by the ISPE in agreement with A3P, approved globally by PHSS and all of these A3P proposals are supported by LEEM.

A3P GIC's main proposals for the revision of Annex 1 were the subject of presentations at congresses and professional meetings in 2015 such as the Quality Days in Lille in January, PDA Microbiology in Berlin in February, A3P Technologies Barriers in March in Vaudreuil and ISPE in Frankfurt in May. The ICG A3P Annex 1 is scheduled to participate in the roundtable organized by PHSS in London in September in the presence of the leader of the EMA / PICS review group.

The next deadlines will be possible discussions with the Annex 1 EMA / PICS revision group and especially the responses to the draft which should be proposed before the end of the year and for which the members could be consulted. An update on the status of the revision process of this Annex 1 should be done at the next 19 International Congress next November.

  Composition of the ICG Appendix 1

  • Sophie AMADIO - Lilly, A3P
  • Marc BESSON - Sanofi PDA Task Force
  • Olivier LUCKL - Merial
  • Pierre Devaux - ACM Pharma
  • Jean-François DULIERE - Technip, ISPE
  • Lina Ertle - Rock
  • Eric HURTUBISE - Merck
  • Philippe ROBIN - Jacobs
  • Patrick Turlier - GSK, LEEM, A3P
  • Patrick Baleriaux - Aseptitech, ISPE
  • Lydia BRETEAU -Boiron
  • Stéphane COUSIN - Catalent until 03 / 2015
  • Philippe DUHEM - Intertek, ISO
  • Morad EL Gueddari - Cell For Cure
  • Julien TRIQUET - Aspen
  • Yves ROCHE - IFIS
  • Dominique Weill - Sterigene, ISO CEN
  Summary: Group S: P Group 7: 17 Manufacturers: Suppliers 11: 9

2 sub-working groups:
- The principles and guidelines of Annex 1 (Sub-Group S),
- Specific points to correct, explain, introduce or delete (Subgroup P).



ICM Document Database Appendix 1 (Login required for access)