News and Events

  • Biosafety of Biological Drug Products (16/10/2017 - 17/10/2017)

    Biosafety of Biological Drug Products   Course Topics Include: •    Determine Special Regulatory and Safety Considerations Governing Biologics •    Explore Manufacturing Controls Required to Bring a Product from Laboratory to Market •    Comprehend Special Concerns Regarding Appropriate Animal Testing for Biologically-Derived Substances   To be presented at: Parc Cientific de Barcelona Baldiri Reixac 10 08028 Barcelona, ...

  • Lyophilization Technology: The Theory and Practice of Freeze Drying of Pharmaceuticals (20/04/2017 - 21/04/2017)

    Lyophilization Technology: The Theory and Practice of Freeze Drying of Pharmaceuticals Course Topics Include: Small molecules and biologicals Design of freeze drying cycles Cycle optimization, Scale-up/transfer considerations Quality control, validation, regulatory aspects Equipment, temp/pressure probes, control and qualification Container-closure selection and qualification   To be presented at: Parc Cientific de Barcelona Baldiri Reixac 10 08028 Barcelona, Spain   For complete course information see ...

  • Stability Testing for Protein Drug Products & Substances: A Life-cycle Approach (19/09/2016 - 20/09/2016)

    Stability Testing for Protein Drug Products and Substances: A Life-cycle Approach   Course Topics Include: - FDA and EMA Regulatory Expectations - Protocols and Reports - Out of Specifications (OOS) and Out of Trends (OOT) Results -Case Studies/Workshops   To be presented at: Parc Cientific de Barcelona Baldiri Reixac 10 08028 Barcelona, Spain   For complete course information see Course brochure, call: ...

  • CMC Simulation: A Hands-on Approach to Global Marketing Applications (30/06/2016 - 01/07/2016)

    CMC Simulation: A Hands-on Approach to Global Marketing Applications Interactive Workshop on the Quality Section of Regulatory Submissions   Course Topics Include: -Real hands-on, practical case studies, for small and large biological molecules in a simulation format -Strategic writing for the CMC section of ...

  • STERILE PRODUCTS: Formulation, Manufacture and Quality Assurance (01/03/2016 - 02/03/2016)

    Sterile Products: Formulation, Manufacture and Quality Assurance Course topic include: -Formulation and manufacture of solutions, suspensions, and lyophilized products -Stability -Freeze-drying principles -Sterile packaging -Sterile unit operations -Sterilization principles -Aseptic processing -Particulate matter -GMP trends   To Be presented at Parc Cientific de Barcelona Baldiri Reixac 10 08028 Barcelona, Spain For complete course information see course brochure, call: +34 93 ...

  • Drug Product Stability and Shelf Life: An Intensive Review of Technical and Regulatory Aspects (28/09/2015 - 29/09/2015)

  • SiTec PharmaBio and Primex ehf partner in an R&D project (04/09/2015)

    SiTec PharmaBio and Primex ehf partner in an R&D project to convert bioindustrial waste into high value products SiTec PharmaBio and Primex ehf, an Icelandic marine ...

  • Atomization and Spray Drying: Applied and Practical Approach (25/06/2015 - 26/06/2015)

  • COURSE RESCHEDULED: Effective QbD (Quality by Design): A Second Generation Approach (29/10/2014 - 30/10/2014)

    Course Rescheduled: Effective QbD (Quality by Design): A Second Generation Approach   Course Topics Include:   • Pharmaceutical, Cosmetic, Nutraceutical & Food Industries • QbD Concept • The ...

  • Safety Assessment and Biocompatibility Evaluation: Medical Devices and Combination Products (11/06/2014 - 13/06/2014)

    Safety Assessment and Biocompatibility Evaluation for Registration of Medical Devices and Combination Products   Course Topics Include: • Principles of Testing Materials • Products for Biocompatibility and Safety • Regulatory Requirements for Development • Marketing Approval of Medical Devices • The ...

  • PHARMACEUTICAL GAS SYSTEMS: DESIGN, VALIDATION, TESTING & INVESTIGATION (10/04/2014 - 11/04/2014)

    Pharmaceutical Gas Systems: Design, Validation, Testing & Investigation   Course Topics Include: • Step-by-step Process Guidelines • Data Management • Out of Specification Results • Trending • Case Studies • Practical Discussions     To ...

  • WRITING & IMPLEMENTING CLINICAL PROTOCOLS (31/03/2014 - 01/04/2014)

    Writing & Implementing Clinical Protocols   Course Topics Include: • Protocol Design Team • Investigator's Brochure • Content and Format • FDA/ICH Obligations   To be presented at:   Parc Cientific de Barcelona Baldiri Reixac ...

  • Publication: Critical gases for critical issues: CO2 technologies for oral drug delivery (31/03/2014)

    Review Critical gases for critical issues: CO2 technologies for oral drug delivery. Hana Danan, Pierandrea Esposito. Therapeutic Delivery; February 2014, Vol. 5, No. 2, Pages 205-232. (doi:10.4155/tde.13.146)

  • Solid Microparticles from Liquid Gases: A Novel Dense CO2 Technology to Address Oral Drug Delivery (12/03/2014 - 13/03/2014)

    Solid Microparticles from Liquid Gases: A Novel, Dense CO2 Technology to Address Oral Drug Delivery Challenges.   To be presented by: Dr. Pierandrea Esposito at: SMI 11th Annual Controlled Release Conference, London (UK)

  • Poster: Celecoxib loaded microparticles obtained by VarioSol® technology (09/09/2013 - 11/09/2013)

      Celecoxib loaded microparticles obtained by VarioSol® technology Poster presentation at: 19th International Symposium on Microencapsulation 9 - 11 Sept. 2013 Pamplona Spain

  • Characterization of Proteins for Development and Approval of Protein Pharmaceuticals and Vaccines (25/06/2013 - 26/06/2013)

    Characterization of Proteins for Development and Approval of Protein Pharmaceuticals and Vaccines   Course topics include: Fundamentals ...

  • Publication: Dense CO2 technology for development of ketoprofen microparticles (30/11/2012)

      A novel dense CO(2) supercritical fluid technology for the development of microparticulate delivery systems containing ketoprofen.     Segale L, Mannina P, Giovannelli L, Danan H, Esposito P, Galli L, Pattarino F.

  • Powders: Their Properties and Processing (01/10/2012 - 03/10/2012)

    Powders: Their Properties and Processing Course Topics Include: Powder Characterization Drying, Mixing and handling Powder Extrusion and Spheronization Property Modifiers Quality by Design ...

  • Non-Clinical Drug Safety Evaluation and Drug Development (14/05/2012 - 16/05/2012)

    Non-Clinical Drug Safety Evaluation and Drug Development A Comprehensive Explanation of the Non-.Clinical Development of Drugs and Biologics  Course Topics Include: Pharmaceutical Toxicology ADME Evaluation The IND Game Developing Oncology Drugs Meeting 505(B)(2) Requirements   To be presented at:  Parc Cientific de Barcelona Baldiri Reixac 10 08028 Barcelona Spain   For complete course information please see course brochure or call: Tel: +34 934487156 e-mail:

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