Dominique Patrone

Dominique Patrone

General Manager / Vice President PharmaBlue & Pharmacovigilance

Key Knowledge Areas:

Quality management

  • Quality Management System
  • Sales representatives certification process
  • Support and advice for « Exploitant » status dossier

 

Pharmacovigilance

  • Local responsible person for PV

 

Certified Auditor

  • “Exploitant” inspection readiness and self-inspections
  • Warehouse and distribution
  • Pharmacovigilance
  • Promotional activities certification

 

Contact

Education

Dominique holds a PharmD from the University of Montpellier and a Master’s degree in European Regulatory affairs.  

 

About Dominique

Dominique has extensive regulatory, PV and quality management skills developed over 20 years in life science consultancies (Parexel & Quintiles) as well as pharmaceutical companies (Expanscience, Baxter, Novex Pharma, Warner Chilcott, Amicus Therapeutics, Ultragenyx).

 

She has extensive experience in EMEA and export countries gained through several positions in the pharmaceutical industry and consultancy companies over the past 20 years.

 

Dominique is also a qualified quality auditor for the Pharmaceutical Industry.

Background/Past experience

Dominique previously worked for Amicus Therapeutics and Ultragenyx Pharmaceutical as Responsible Pharmacist in France.  She was responsible for setting up the pharmaceutical entities as a distributor (Exploitant) and also for the creation and maintenance of the QA System according to GMP, GDP and GVP supporting the launch of a new orphan drug product.

At Warner Chilcott Dominique was a Responsible Pharmacist (“Exploitant” & local QPPV) with management responsibility for the organization of pharmaceutical operations in compliance with relevant regulations and GxP, collaborating with manufacturing and distribution sites, QA and PV Global teams.

Dominique has experience in CROs with 6 years’ service at Quintiles acting as Responsible Pharmacist and local QPPV.  She was also Director of Clinical Operations France for Quintiles Benefit France.

Finally, Dominique has direct regulatory affairs experience in roles at Baxter, Aventis Pharma, and Laboratories Expanscience working in CMC in local and European RA activities.

At BlueReg Group, Dominique is managing the PharmaBlue operations team by providing services in Early Access Programmes in France, managing pharmacovigilance, and providing strategic support as a member of the Leadership Team.