Pierrette ZORZI

Consultant for Bio/Biotech products : Therapeutic proteins, Recombinant products including monoclonal antibodies and fusion proteins, Biosimilars products, Advanced therapy medicinal products (ATMP)-Head of the Department for Evaluation of Biologicals at the French Drug Agency (ex-Afssaps, now ANSM) until 2011. Member of the BWP at EMA, acting as assessor and participating to the drafting of many guidelines. EMA representative for the development of ICH biotech guidelines.At the WHO level, member of the Blood Regulation Network (BRN).-Previously in the pharmaceutical industry, most of it in the biotechnology sector, acting in the field of drug development and regulatory affairs. EFPIA representative for all ICH bio topics and ICH rapporteur for the guideline on specification (Q6B). My services address Quality aspects (part III of the CTD) : • Development strategy : manufacturing and quality issues • Regulatory strategy for clinical trials, MAA, variations (comparability)• Dossier organization• Training and conference presentations