Andrea Pricca Email & Phone Number

Milano

Milano, Italia

Administrator of Company’s Global Safety Database (LifeSphere Safety MultiTenant Database - ARISg).Project Manager and Key User of Company’s Global Safety Database E2B R3 - Upgrade and Validation ongoing-Process.Reference Person for Management of Clinical Trials.Signal Detection Chairman of Clinical Trials.Member of Safety Review Board.Active participation to Inspections made by National Competent Authority (AIFA), European Competent Authority (EMA), American Competent Authority (FDA) and audit performed by third party provider and Partners.Preparation of Safety Aggregate Reports (PSUR/PBRER, DSUR, RMP, PADER, Clinical Overview) to Regulatory Authorities, Ethic Committees and Partners worldwide.Participation to Signal Detection process (extraction of data, participation to SRB meeting, review of SD report).Preparation, review and finalization of Policy, Governance (GOV), Standard Operating Procedure (SOP), Working Instruction (WI) and Pharmacovigilance System Master File (PSMF) at global level.Reference person for Biotech products: oversight of case processing and safety information exchange and submission at global level with Regulatory Authorities and Partners; management of relevant Safety Data Exchange Agreements (SDEA) and Pharmacovigilance Agreement (PVA).Management of PhV for clinical trials (SAEs management, Reconciliation with Clinical Database, Protocol, IB and Safety Plan review).Reference person for clinical trials management at global level.

Milano, Italia

Administrator of Company’s Global Safety Database (LifeSphere Safety MultiTenant Database - ARISg).Project Manager and Key User of Company’s Global Safety Database E2B R3 Upgrade and Validation Process.Reference Person for Management of Clinical Trials.Signal Detection Chairman of Clinical Trials.Member of Safety Review Board.Collecting, classifying, triage, quality control, medical evaluation, follow up of International case reports from all sources, regarding medicinal products, medical devices, cosmetic products and nutraceutical products, for both investigational and marketed ones. Management of the PSMF.International and Local Literature screening supervisor. Management of PhV for clinical trials (SAEs management, Reconciliation with Clinical Database, Protocol, IB and Safety Plan review). Draft, finalization and management of Safety Data Exchange Agreements (SDEA). Participation to Signal Detection process (extraction of data, participation to SRB meeting, review of SD report).Generation, review and submission of Safety Reports (CIOMS I, line listings, tables, PBRERs, DSURs, RMP etc) to Regulatory Authorities, Ethic Committees and Partners. Support in writing and Quality Check of Safety Aggregate Reports (PSUR/PBRER, DSUR, RMP, Clinical Overview). Writing and review of internal SOP and WI.Supporting PhV training activity of internal/third party provider personnel. Monitoring compliance and performance (KQI and KPI) of internal and partners’ activities. Active participation to internal audit and CAPA resolution. Active participation to NCA (AIFA) PhV Inspection.

Milano, Italia

Collecting, classifying, triage, quality control, medical evaluation, follow up and archiving of all Italian and International adverse drug reactions (ADRs) from all sources for investigational and marketed products.Management of PhV for clinical trials (SAEs management, Reconciliation with Clinical Database).Generation, review and submission of Safety Reports (CIOMS I, line listings, tables, PBRERs, DSURs, RMP etc) to Regulatory Authorities, Ethic Committees and Partners.Support in the management of Safety Data Exchange Agreements (SDEA).International and Local Literature screeningSupport in writing and Quality Check of Safety Aggregate Reports (PSUR/PBRER, DSUR, RMP, Clinical Overview). Writing and review of internal SOP and WI.Supporting PhV training activity of internal/third party provider personnel. Monitoring compliance and performance (KQI and KPI) of internal and partners’ activities. Active participation to internal audit and CAPA resolution. Active participation to NCA (AIFA) PhV Inspection.

Milano, Italia

24/7 availability with Italian Competent AuthorityManagement of RMP and implementation of RMMs at local level.Management of ICSR, collection, classification, triage, quality control, medical evaluation, follow up and archive of ICSRs from all sources for marketed product in the Italian Country.Reconciliation with local partners and US HQ on PhV activities

Management of worlwide Individual Case Safety Reports (ICSRs); Monthly reconciliations; Writing and/or reviewing standard operating procedures; Supervision of national and international PhV networks for new ICSRs; Management and request of Follow Up; Management of foreign consultants and Pharmacovigilance Local Contact Points. International and local literature screening. Participation to AIFA PhV Inspection and implementation of the consequent CAPA plan.

Quality control of finished products and raw materials in laboratory, including High-performance liquid chromatography, Ultraviolet–visible spectroscopy, Infrared Spectroscopy and Thin-layer chromatography.

Update of packaging, Patient Information Leaflet, SmPCs; Update of CTD/e-CTD and management of certificates (cGMP, CEP/COS, DMF, ISO, Hala/Kosher, Allergens, BSE/TSE, REACH, Residual solvents, GMO) for the products commercialized all over the world.

Preparation and review of protocols, in accordance with cGMP, Merck Manufacturing Divisional Guidelines, Policies and Procedures Standard Site; sampling activities, data collection, management of atypicals/deviations, and compilation of Final Reports.Supervision of the manufacturing process for all the kind of products, including the newest one, built up following the brand new concept of Quality by Design (QbD).

Pharmaceutical Technology LaboratoryPreparation and characterization of injectable systems composed of thermosensitive composite hydrogel (ISFcG - In Situ Forming composite Gel) for bone regeneration.In collaboration with:- Fondazione IRCCS Policlinico San Matteo, Pavia (Italy)- Geistlich Pharma AG, Wolhusen (Switzerland)

Signal Management In Pharmacovigilance

Apply the basic concepts and principles of signal detection in pharmacovigilance, from simple visualisation and tabulation methods.

Benefit-Risk Management

Describe safety, efficacy, and effectiveness profiles of drugs; Plan safety and efficacy follow-up systems, including the best choice.

Eudravigilance Information Day

Adverse reaction reporting and analysis, EudraVigilance system changes to come Definitions, principles, processes and reporting of ICSRs.

Drafting And Managing Pharmaceutical Safety Data Exchange Agreements

Commercial arrangements in the pharmaceutical industry Contract basics Regulatory requirements Negotiating, drafting and managing.

Coding With Meddra And Meddra Safety Data Analysis And Smqs

La Farmacovigilanza 2.0 (As Speaker)

Digital Marketing in Healthcare area Pharmacovigilance opportunities in the digital world: report, evaluation and communication Safety.

Abcs Of Gcp And The 13 Principles Of Ich

Eu Qppv And Local Contact Person For Pharmacovigilance

Ii Level Master In “Pharmaceutical Technology & Regulatory Affairs

- Thesis Title: "Management and differences between Quality by Testing and Quality by Design approaches, with the resulting benefits".

Single Cycle Degree, Chemistry And Pharmaceutical Technology

Experimental thesis in Pharmaceutical Technology, with the collaboration of: Fondazione IRCCS Policlinico San Matteo, Pavia (Italy).