Jean-François Duliere

ISPE
Regulatory Advisor
Jean Francois Duliere is a Pharmacist by education. Jean Francois started his professional life 20 years in pharmaceutical industry Quality Control, Production in various positions and various fields, OSD, Steriles, API from Bacteria growth. Jean Francois joined after this production experience an Engineering company Technip where he stayed for 20 years doing facilities design for OSD; Sterile, Biotech, Vaccines, Advanced Therapy Medicines facilities. In charge of early design stages and GMP compliance of most of Technip's pharma projects.

Jean Francois is involved in many ISPE working groups and committees.

Chair of PIC/S Annex 2 commenting groups.

Chair of Draft 7 (2017) Annex 1 commenting process 2018 presentation In Rome Conference, Panel discussion with regulators.

Chair of Draft 12 (2020) Annex1 Commenting group.

Related Articles

Article
Features
ISPE Comments to the Annex 2 PIC/S Draft Revision

Annex 2 is the Good Manufacturing Practices (GMP) document by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) addressing manufacture of biological medicinal substances and products for human use. This article shares information about Annex 2 and ISPE’s submitted comments to the draft revision of Annex 2 that was released for public consultation in September 2019.