Claire SOUPPART

En résumé

Entreprises

• Novartis AG - DRA global submission dossier reviewer

  RUEIL MALMAISON 2012 - 2013 Review of overall summary documentation for submission dossier to EMA (CTD Module 2) and Japanese health authorities for two new chemical entities.

• Novartis AG - Global labeling manager

  RUEIL MALMAISON 2008 - 2013 • Developed, coordinated and implemented responses to Health Authority requests writting Clinical Overviews (COs)
  • Managed the quality, accuracy, compliance with internal and external standards and the timely production of submission documents
  • Created and maintained company core data sheet (CCDS), critical regional labeling (SPC,US PI) and patient leaflet
  • Led interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices
  • Analyzed and interpreted pharmacokinetics (PK), efficacy and safety data
  • Performed literature searches/reviews as necessary to obtain background information for development of documents
  • Advanced experience in a global-matrix and multi-cultural environment or cross-functional teams in the pharmaceutical industry
  • Provided regulatory guidance and training to team members and external partners
  • Knowledge of industry trends for dossier preparations (e.g. IND/CTA/NDA/NDS)
  • Understanding of pharmaceutical development, clinical research, study design, biostatistics, pharmacokinetics, regulatory environment, project management and medical terminology
  • Proficient in pertinent software and tools (e.g. MS Office, eCTD viewers, etc...)
  

• Novartis AG - Senior Clinical Pharmacokineticist

  2002 - 2008 • Designed strategy for clinical pharmacokinetics (PK) development of a new drug and contributed to clinical development plans
  • Designed PK component of Clinical Pharmacology (CP) and Clinical Research (CR) studies
  • Wrote PK study protocols, interpreted PK data and wrote PK component of CP/CR study reports
  • Evaluated PK/PD relationships
  • Wrote clinical PK sections of Investigator Brochure (IB), Clinical Expert Report, IND/NDA documents
  • Wrote Summaries of Clinical Pharmacology in submission dossier
  • Answered Health Authorities PK questions on labelling or submission dossier
  • Led Clinical Pharmacology sub-teams
  • Represented Clinical Pharmacology in multidisciplinary task forces/teams
  

• Novartisn SAS - Head of Laboratory in Bioanalytics and PK

  1997 - 2001 Head of a Laboratory of Research and Development (3 technicians). Research and development of analytical methods (physicochemical methods) and analysis of actual biological samples. Toxicokinetics and plasma protein binding evaluations. Writing of analytical method reports, bioanalytical data reports for clinical trials, toxicokinetic data reports, and plasma protein binding reports. Contribution to Investigator’s Brochure, Product Characteristics summary and Human Pharmacokinetics and Bioavailability summary.
  Represented Bioanalytics and Pharmacokinetics to International Project Teams for software evaluation. Membership of multidisciplinary task forces/teams in support of continuous improvement and other management objectives.
  

• Laboratoires Ciba Geigy - Research Executive

  1994 - 1997 Development of analytical methods (physicochemical methods) and analysis of actual biological samples. Management of the PK data of clinical trials. Toxicokinetics, pharmacokinetics and statistic evaluations during the various phases of the pharmaceutical development. Interpreted data and evaluated PK/PD correlations. Writing of analytical and pharmacokinetic data reports. Supported/trained technicians.

• Laboratoires Ciba Geigy - Chemist

  1974 - 1993 Development of analytical methods (physicochemical methods) and analysis of actual biological samples. Toxicokinetic and pharmacokinetic evalutions.

Formations

• French National Society Of Professional Engineers

  Paris 1997 - 1998 Ingénieur professionel

• Institut Universitaire De Technologie IUT (Orsay)

  Orsay 1972 - 1974 DUT

Réseau

Pas de contact professionnel