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ICG annexe1

Dice 2013 October, during the final round table of the International Congress A3P in Biarritz, A3P was interested in the revision of Annex 1. A GIC was established 2014 start by ten experts extended to 20 below after a call motivated to participate and clarify its objectives during its first meeting on January 7 2014:

- Specify the principles, guidelines and main chapters that should contain the new version,
- Indicate the specific points to benefit from corrections, additional explanations,
or deletion,

- Introduce additional points made by the other-between new technologies and therapies.

Numerous exchanges and meetings and the round table with interactive voting during the last International Congress in October 3 A2014P, have led to sending a response to the Concept Paper EMA / PICS for the revision of Annex February 1 2 2015 of containing fifteen general comments published in the issue of The Wave 46 and 120 about specific comments which will be summarized in the following proposals 57 47 number. These general comments have been fully taken up by ISPE according to A3P overall PHSS and approved all these proposals A3P is supported by the LEEM.

The main proposals of the ICG A3P for the revision of Annex 1 were the subject of presentations at professional conferences and meetings 2015 such as the Days of Quality in Lille in January, PDA Microbiology in Berlin in February, A3P Technologies Barriers in March at Vaudreuil and ISPE in Frankfurt in May. The ICG A3P Annex 1 should participate in the round table organized by the PHSS in London in September in the presence of the leader of EMA Group / PICS for the revision.

The next elections will be possible discussions with the Annex review group 1 EMA / PICS and especially replies to the Draft that should be proposed before the end of the year and for which the members could be consulted. An update on the progress of this Appendix 1 review process should be done at the next international congress on November 19.

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 - Roche
  • Eric HURTUBISE - Merck
  • Philippe ROBIN - Jacobs
  • Patrick Turlier - GSK, LEEM, A3P
  • Patrick Baleriaux - Aseptitech, ISPE
  • Lydia BRETEAU -Boiron
  • Stéphane COUSIN - Catalent up to 03 / 2015
  • Philippe DUHEM - Intertek, ISO
  • Morad EL Gueddari - For Cell Cure
  • Julien TRIQUET - Aspen
  • Yves ROCHE - IFIS
  • Dominique Weill - STERIGENE, ISO CEN
Summary: Group S: P Group 7: 17 Manufacturers: Suppliers 11: 9

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



ICM Document Database Appendix 1 (Login required for access)


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