Nundesh GUNGADIN

En résumé

Entreprises

• INC Research - Biostatistician, Clinical Data Manager, Drug Safety Manager

  1988 - maintenant 2004 - 2011 : Drug Safety Manager
  Expert in the Set-up of Safety and Pharmacovigilance processing for clinical trials ranging from Phase I to Phase IV. Initiating the Safety databases (AERS), supervising all reporting to Health Authorities, EMA, Ethics committees (local and Central),
  Expert knowledge of Reglementary Rules and Regulations World-wide( North America, South America, Europe, Asia, Asia Pacific, Australasia.
  Expert in coding with MedDRA, WHODRUG, ICD9 ...etc and all current dictionaries used in the world.
  Expert in SAE Reconciliation, editing of CIOMs, Medwatch , also writing ASRs, PSURs.
  Expert in writing the Safety Chapters in the Study Protocols, writing Safety processinng plans, Safety Standard operating procedures and editing CRFs pages for the capture of Adverse events and Serious adverse events.
  Expert in training clinical teams (investigators, CRAs, junior staffs) in Safety processing
  1988 - 2004 : Biostatistisian, then Clinical Data Manager.
  
  In all over 300 clinical trials treated ranging from Phase I to Phase IV and from Single subject trial to trials with over 40000 subjects.
  
  Contributing to several millions of Dollars invested worldwide.

Formations

• University Of Surrey (Guildford)

  Guildford 1981 - 1983 MSc
  
  Experimental methodology et applied statsistics

• Ecole Polytechniques De Londres (Londres)

  Londres 1978 - 1981 Bsc Honours
  
  Psychologie et Statistique appliquée - Honours

Réseau

• Angelo GONCALVES

• Assia DOUICI

• Dr Juliette LONGIN

• Eric MARTHINET

• Ioana DINCA

• Julie HEBERT-DARBONNA

• Marina JOLY

• Stanislas KRASENSKY

• Vincent ROLLIN