Regulatory and Pharmacovigilance

Regulatory and Pharmacovigilance 2019-07-29T08:39:10+00:00

The regulatory activity includes the development and supervision of dossiers and documentation regarding national and European authorisation procedures for medicinal products (Orphan Designation, Development Plan for Children, Scientific Advice, Centralised Marketing Authorisation, Advanced Therapy, etc.), including authorisation to perform national and multinational clinical trial activities with access to EudraVigilance and EUDRACT.

With reference to clinical trials, CVBF can function as Sponsor and as Contract Research Organization (CRO) with regards to authorisations, contracts, identification of satellite centres at national and international level, monitoring, audits, statistical reports, pharmacovigilance.

Experiences

Pharmacovigilance activity in clinical studies of a product intended for the treatment of neonatal sepsis and bacterial meningitis in paediatric patients under 3 months of age 2013
Writing of an Orphan Designation Dossier (ODD) of a product intended for the treatment of hypoxic-ischemic encephalopathy in infants 2012
Preparation of the Paediatric Investigation Plan (PIP) of a product intended for the treatment of chronic pain in paediatric patients 2012
Preparation of the Paediatric Investigation Plan (PIP) of a product intended for the treatment of neonatal bacterial sepsis in paediatric patients under 3 months of age 2012
Preparation of a feasibility study, support to the regulatory procedures of Scientific Advice (SA) and Preparation of a Paediatric Investigation Plan (PIP) for a product intended for the treatment of hypothyroidism 2011
Preparation of the CTA documentation for conducting a clinical trial to evaluate the efficacy and safety of two oral chelators in paediatric patients with transfusion-dependent hemoglobinopathies 2011
Preparation of Paediatric Investigation Plan (PIP) of a product intended for the treatment of iron overload in paediatric patients with transfusion-dependent hemoglobinopathies 2011
Drafting and preparation of the Investigator’s Brochure and IMPD of a product intended for the treatment of neonatal sepsis and bacterial meningitis in paediatric patients under 3 months of age 2010
Preparation of the Paediatric Investigation Plan (PIP) of a product intended for the treatment of neonatal sepsis and bacterial meningitis in paediatric patients under 3 months of age 2010
Qualitative and quantitative assessment of a formulation intended for the treatment of a rare disease in infants 2010
Preparation of a dossier for Orphan Designation (ODA) for the treatment of a chronic myeloproliferative disorder 2009
Preparation of the prevalence section of a dossier for Orphan Designation (ODA) for the treatment of a paediatric brain tumour 2009
Preparation of a dossier for Orphan Designation (ODA) for the treatment of ovarian cancer 2009
Preparation of the Paediatric Investigation Plan (PIP) and of a dossier for Orphan Designation (ODA) for the treatment of a type of juvenile arthritis 2009
Preparation of the Paediatric Investigation Plan (PIP) of a product for the prevention of the complications of bone marrow transplantation 2009
Preparation of a dossier for Orphan Designation (ODA) for the prevention and treatment of a product for the prevention of the complications of bone marrow transplantation 2008
Critical evaluation of the regulatory documentation (CTD) for the registration of a product intended for the newborn 2008
Support to the regulatory procedures of Protocol Assistance for the orphan designation for a rare form of conjunctivitis 2007
Support to the preparation of the clinical protocol and regulatory procedures of Protocol Assistance for the development of a paediatric product with designated orphan indication 2007
Preparation of a dossier for Orphan Designation for the treatment of rare form of autism 2007
Evaluation of the regulatory compliance of anti-asthma products to the procedures established by the Paediatric Regulation 2007
Preparation of the Paediatric Addendum to the Expert Assessment of an antitussive drug product 2004
Proposal for a commercial placement of a dietary supplement in Italy/Europe 2004
Analysis and preparation of the CTD of a product intended for cosmetic sclerotherapy 2004
Conformity assessment of paediatric clinical protocols with national and European guidelines 2004
Feasibility study to extend the market exclusivity of a product intended for the treatment of a rare disease 2004
Preparation of the Protocol Assistance of an orphan product for the prevention of complications of radiotherapy 2004
Preparation of a dossier for Orphan Designation (ODA) of a product for the prevention of complications of radiotherapy 2004
Possible impact on the European market of a new surfactant designated as an orphan medicinal product 2003