Pierrette Zorzi

Ex-Regulator (French Agency), ATMPs, Biosimilars, CMC Biotech Products


Pierrette Zorzi is a pharma-biotech consultant, recently retired from Afssaps (French Agency for the Safety of Health Products, presently renamed Agence Nationale de Sécurité du Médicament/ANSM) where she worked for 11 years as head of the Department for Evaluation of Biologicals. Products covered by the department were recombinant and extractive products, vaccines, plasma derived medicinal products, blood products, cell and gene therapy products, tissues, organs and ancillary products. Activities covered were marketing authorizations, post approval variations, clinical trials, scientific advices, contribution to national and European legal frameworks and technical guidances. The department was also in charge of the haemovigilance and biovigilance.


Within the European Committee for Medicinal Products for Human Use (CHMP) at the EMA, she has been a member of the Biology Working Party (BWP), acting as the french representative. She was the rapporteur and co-Rapporteur for a large range of Biopharmaceuticals, and she contributed to the setting of many guidelines, among which Process Changes, Biosimilars, Cell therapies (ATMP). She was also member of Biosimilar Medicinal Products Working Party (BMWP), and member of the Cell therapy Working Group (CTWP). 


She was the EMA representative for the development of ICH guidelines on biotech products: Q5E (comparability), Q11 (Development and Manufacture of Drug Substance). At the WHO level, she was member of the Blood Regulation Network (BRN). Before joining Afssaps in 1999, she was in the pharmaceutical industry for 25 years, most part of it in the biotechnology sector, acting in the field of drug development and regulatory affairs. During this period, she was the EFPIA representative for all ICH bio topics and ICH rapporteur for the guideline on specification (Q6B). She participated to many conferences, presenting the French and European regulatory systems as well as various technical guidelines. P. Zorzi is graduated in Pharmacy and holds a French MBA. 

 

Areas of expertise: CMC Biotech products

  • Development strategy in manufacturing and quality issues (cell bank system, manufacture, product specification and stability, viral safety…)
  • Regulatory strategy for Clinical trials, Scientific advices, MAA, Variations (comparability)
  • Dossier organization