Veronique CHAMPAULT

En résumé

Entreprises

• Reckitt Benckiser - Regulatory Affairs Manager Western Europe

  Massy 2014 - maintenant • Regulatory Affairs : product registration (National procedure, MRP and Centralized procedure), variation preparation and compliance activities in relation to registration. Management of DBMS (Trackwise/Documentum/Grais),
  • Quality Control of promotional materials, management of DMOS law including the Transparency and public disclosure of company links with HCPs & HCOs,
  • Compliance of the operating site. Third parties technical agreements approval. QMS maintenance (SOP and staff training)
  

• ViiV Healthcare SAS - Pharmacien Responsable/ Directeur Affaires Pharmaceutiques

  2010 - 2013 Qualified Person/ Head of Regulatory Affairs at ViiV Healthcare:
  
  Establishing the Quality Assurance system
  - Creation and organization Regulatory Affairs department in close collaboration with GSK
  - Leading of the implementation of the initial force certification
  - Ensuring the compliance of Promotional Materials and Anti-Bribery policy (DMOS law)
  
  I joined ViiV Healthcare, an innovative biotech joint venture between GSK and Pfizer dedicated to HIV products in 2010. As regulatory affairs leader, quality and compliance Director and Responsible Pharmacist, I am managing all compliance activities (promotional tools checking, internal and external audits conducting, etc) and overseeing regulatory activities (early access program, registration, post-licensing activities).

• Gilead Sciences - Directeur Affaires Réglementaires/ Pharmacien Responsable

  1998 - 2010 Qualified Person/Head of regulatory Affairs at Gilead Sciences:
  
  - Creation and organization of the Regulatory Affairs department (early access program, registration and post licensing activities)
  - Establishing the Quality Assurance system and manage several French authorities inspections and internal corporate audits
  - Ensuring the compliance of Promotional Materials and Anti-Bribery policy (DMOS law)
  - Acting as local Pharmacovigilance QP
  
  I joined ViiV Healthcare, an innovative biotech dedicated to infectious diseases HIV products in 1998. As regulatory affairs, quality and Pharmacovigilance Director and Responsible Pharmacist, I am managing all compliance activities (promotional tools checking, internal and external audits conducting etc) regulatory activities (early access program, registration, post-licensing activities), Pharmacovigilance activities (SAR collection and reporting, PSUR review and submission, internal audit performing etc).
  
  During the past 11 years I have created and supported the growth of the French affiliate in a changing organization and also built and developed a team of 5 people managing Regulatory affairs (pre and post marketing regulatory activities) and Pharmacovigilance and Compliance activities. I also acquired an expertise in early access to the market through ATUn and ATUc program and also expertise in clinical trial applications and GCPs also.
  From 2002 to 2009, I managed the launch of 7 products onto the hospital and retail markets by coordinating the market access activities, promotional materials sign-offs and by organizing the product supply.

• Laboratoire Guerbet - Responsable Assurance Qualité

  1992 - 1998 I developed the AQ department by recruiting and developing my team of 4 peoples. I acquired different expertise in GMPs/GDPs in production, pilot plants and warehouse sites. I became the Qualified Person deputy and developed relationships with French authorities (product batch recall, inspections, product customer complaints management, ...) and external suppliers (audits, negotiations for quality issues and writing Quality Agreements...).

• Synthélabo/ Laboratoire Delagrange - Affaires Réglementaires/Contrôle Qualité/ Assurance Qualité

  1988 - 1992 I joined the Laboratoire Delagrange and I acquired wide industrial experience in quality assurance, quality control and manufacturing with main interactions with R&D department too. It was also my first experience in management (13 technicians) in a difficult environment involving huge job cuts.
  
  During my first experience in Regulatory Affairs, I was in charge of the update of MA files, promotional materials and artworks sign-off

Formations

• Institut D' Études Politiques De Paris. Sciencespo

  Paris 2014 - 2014 Certificate in European Healthcare, Ethics and Regulation
  
  Training managed by Seton Hall University - NJ - USA

• Institution Supérieur De Gestion

  Paris 1987 - 1988 Master ´ s degree

• Faculté De Pharmacie - Université Paris-Sud XI (Chatenay Malabry)

  Chatenay Malabry 1982 - 1987 Doctor in Pharmacy (Pharm. D)
  
  Industry option

Réseau

• Eric GUIGNARD

• Fabrice MEILLIER

• Jerome PRADIER

• Julie BONHOMME

• Philippe LE MIGNOT

• Roland SOYEUX

• Sophie JARRIX