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pondělí 17. prosince 2018
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Dr. Dionigio Franchi

Up to December 2010 Dr. Franchi was the Director and Site Lead of the Pharmaceutical Development Department in the R&D of GlaxoSmithKline, Verona, Italy. He has more than 25 years experience in the R&D Verona of GSK, a highly productive and dynamic division, with a solid track record of projects delivery from candidate selection to filing and launch. During 2000-2010 he provided integrated knowledge and data for progressing compounds to the following milestones: 39 Commit to Candidate; 28 FTIH; 22 First Phase II dose; 13 PoC Decisions; 2 NDA/MAA Submissions.

Dr. Franchi has proven technical knowledge and leadership in the pharmaceutical industry, including development and registration of new chemical entities and experience across a range of pharmaceutical dosage forms (tablets, suspensions, injectables).

He possesses consolidated experience in:

  • Operating under a variety of quality systems: Company Standard Operating Procedures; GLP and GMP compliance; GLP authorized testing facilities; controlled drug substances authorization; API manufacturing GMP authorization; drug product manufacturing license;
  • Preparing regulatory inspections, e.g., GMP manufacturing licenses and pre approval inspections;
  • Preparing Chemistry Manufacturing Controls (CMC) sections of regulatory documents (IB, IMPD, IND, NDA, MAA) and addressing regulatory questions.

Dr. Franchi has also special expertise in such areas as biopharmaceutics; understanding of causes of attrition; and “in silico” and “in-vitro/in-vivo” predictions.

In 2011 he was a consultant of APTUIT Srl., Verona, Italy. At present he is a consultant at Nickel Technology Poznan, Poland, acts as an external professor at the University of Pavia, Istituto Universitario di Studi Superiori (IUSS), and as a visiting professor at the universities of Bologna, Firenze, Milano, Siena and Athens.