Antonio Santoro Email and Phone Number

▪ Managed the entire process of the Pricing and Reimbursement applications for new products and new therapeutic indications, actively supporting hearings and negotiation steps; ▪ Coordinated a cross-functional team (Regulatory, Market Access, Medical Affairs, Finance and Marketing) to define the pricing strategy, the place in therapy and the health economic impact in order to finalize the P&R dossier;▪ Defined as main contact point with local competent authorities for P&R and Regulatory issues;▪ Led a team of 3 to work on a company portfolio of 40 authorized medicinal products (mainly centralized and decentralized procedures) to generate an approximate turnover of € 148M;▪ Directly involved in the first Servier global change management program at international level and, as trainer, at national level;▪ Acted as first-line role in strategic national and European projects to develop company portfolio, ensuring the benefit/risk ratio is positively balanced;▪ Managed the Pharmaceutical Area of the company Quality Management System and coordinated cross-functional activities in order to manage procedures and define roles, responsibilities and tasks of impacted functions;▪ Provided one to one or small training groups tutoring in basic skills of procedures falling under the pharmaceutical responsibility area.

▪ Support regulatory activities for National and European procedures (Decentralised, Mutual Recognition) as appropriate, ensuring that all regulatory obligations and business objectives are met and managing the entire product lifecycle.▪ Regulatory submissions preparation and filing (Marketing Authorisations, Variations etc.), responses to Health Authority questions and other correspondence in accordance with EU regulations and guidelines.

Submission of new applications, renewals and variation applications. Dossier management and update. Management for electronic dossier archiving and NTA to CTD/eCTD conversion. Management for inserting new XEVPRMs in Eudra Vigilance WEB portal. Deputy QPPV qualification for control and management of Pharmacovigilance System with back-up procedure.Since September 2012, GAP Analysis activity for the controlled CMO “Special Product’s Line S.p.A.” in order to check the Master Batch Record compliance with the technical documentation available.

Writing dossier in CTD / eCTD format for national registrations and mutual recognition procedures (modules 1, 2, 3);Managing the lifecycle of drug (variations, renewals, etc.).Compilation and management of Periodic Safety Update Reports (PSUR);Traceability management of the drugs through the electronic MOH portal, development of dedicated software SAP-based.

Writing dossier in CTD / eCTD format for national registrations and mutual recognition procedures (modules 1, 2, 3);Managing the lifecycle of drug (variations, renewals, etc.).Compilation and management of Periodic Safety Update Reports (PSUR);Traceability management of the drugs through the electronic MOH portal, development of dedicated software SAP-based.

Use of equipment for extraction, purification and isolation procedures for organic compounds that predominantly come from natural marine organisms.