Director Technical and Scientific Area, Industrial Manufacturing and Quality

• Jan 2021 - Present

Director Technical-Scientific Area, Industrial Manufacturing and Quality

Head of Technical and Scientific Area, Industrial Manufacturing and Quality

• Dec 2015 - Dec 2020

- Technical-Scientific Area, Industrial Manufacturing and Quality.- Coordination of “Industrial and Third part Manufacturing Working Group” of Egualia.- Coordination of “Task force Qualified Person” of Egualia.- Coordination of Supply Chain Group.- Working groups coordination concerning the scientific technical area, supply chain, regulatory, quality and industrial production areas.- Management of contacts with Qualified Persons and Heads of Regulatory Affairs of member companies.- Coordination of Falsified Medicines Directive implementation: Project Leader in Italy for Egualia - (relations with member companies, Medicines for Europe Association (MfE) - and related institutions).- Technical-scientific support for the Falsified Medicines Directive implementation in European Union.- Technical-scientific support to Italian Biosimilars Group (IBG) on issues concerning the biosimilars.- Assessment of issues reported by the member companies / Executive Council and analyses with the competent authorities (AIFA, Ministry of Health).- Study and analysis of the current legislation and related support to members companies.- Regulatory support to other association areas related to Health Authorities (Italian Medicine Agency, Ministry of Health, ISS, EMA, MfE, etc.)- Attendance to the technical meetings & working group.- Support to the member companies regarding the third part manufacturing and Dossier management for Marketing Authorisation.- Monitoring of medicines shortages- Analysis of the industrial manufacturing and supply chain in order to promote the availability of medicines at national and EU level. Show less

Member of Manufacturing Competitiveness Taskforce

• Jun 2022 - Present

Member of Manufacturing and Supply Chain Committee

• Jan 2021 - Present

Member of the Anti-Counterfeiting steering Committee

• Dec 2015 - Present

Member of Scientific Committee

• Jan 2022 - Present

Regulatory Affairs Manager

• Nov 2009 - Nov 2015

- Updating to laws of the regulatory area;- Preparation of administrative procedures and dossiers to be submitted to the competent authorities;- New Product Launch Strategy: Submission of Application Dossier for Marketing Authorization (e-Submission)- Pricing dossier management;- Global Post Approval Regulatory Strategy in EMEA;- Market Access: Price monitoring pharmaceuticals reimbursement by the National Health Service & Pay Back;- Review of the dossier in CTD and eCTD format;- National MA Variations type I and II, in accordance with Regulation 712/2012/UE;- MA Variations type I and II according to centrelized, decentrelized and mutual recognition procedures;- Renewal Application of marketing authorizations;- Updating of SPC and PIL;- Elecotronic Updating of company databases relating to authorization dossier, variations, renewals, approved SPC&PIL, Ministry of Health & AIFA correspondence.- Current use of the SAP software for handling in the warehouse of manufacturing batches, including batch release.- EMEA Quality compliance senior auditor: Frequent GMP inspection activities in Italy and Europe, as Lead Auditor, on behalf of the company Hospira Inc. Show less

GMP senior auditor

• Nov 2009 - Nov 2015

Quality Assurance

• Jun 2004 - Nov 2009

- editing and review of procedures, qualification/validation protocols and reports; - management of deviations and complaint: evaluation of corrective and preventive actions; - change control management; - self-inspection auditor; - supplier audit; - training to personnel; - editing and management of Product Quality Review; - technical dossier evaluation; - quality technical agreement editing; - batch record review; - company compliance to ISO 9001 quality standard. - editing and review of procedures, qualification/validation protocols and reports; - management of deviations and complaint: evaluation of corrective and preventive actions; - change control management; - self-inspection auditor; - supplier audit; - training to personnel; - editing and management of Product Quality Review; - technical dossier evaluation; - quality technical agreement editing; - batch record review; - company compliance to ISO 9001 quality standard.

Fermentation Department Supervisor

• May 2004 - Jun 2004

Biomass purification in Fermentation Department. Biomass purification in Fermentation Department.

Researcher

• May 2003 - Aug 2003

Use of combinatorial libraries for the study of new cancer antigens. Use of combinatorial libraries for the study of new cancer antigens.