PV Focus – Pharmacovigilance and System Auditing Expertise

Our Experience

PV Focus is a newly created company owned and managed by Thierry Hamard. With a Pharmacist background, Thierry has over 10 years of auditing experience across a spectrum of processes related to Clinical Research throughout the world. For the last 5 years, he has focused on Pharmacovigilance processes where he has experienced first-hand Pharmacovigilance Inspections performed by different Regulatory Authorities (FDA, MHRA).

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Academic Background:

Pharmacy Doctorate, University of Angers, France
Post-graduate Diploma in Quality Management, University of Angers, France

Experience in Pharmacovigilance Auditing and Regulatory Inspections:

Thierry has more than 5 years of Global Pharmacovigilance Auditing experience and is now a member of the BARQA Good Pharmacovigilance Practice Committee.

Highlights include major corporate audits and MHRA and FDA Pharmacovigilance Inspections, widely recognized as leading Regulatory Authorities in this field. The following table details the most significant projects:

Period	Project	Role of T. Hamard	Countries Covered
2006	Audit of Pharmacovigilance Operations at the Spanish subsidiary of Bayer HealthCare	Led the preparation, conduct, and reporting of the audit. This audit was performed wit the assistance of 2 Bayer HealthCare auditors.	Spain
2006	Review of Clinical Safety and Pharmacovigilance Processes at the UK affiliate of Kyowa Hakko, including aspects related to EU/RoW coordinating role	Led the preparation, conduct, and reporting of the audit.	UK
2006	Review of Clinical Safety and Pharmacovigilance Processes within Grünenthal Corporate Headquarters and two selected affiliates	Led the preparation, conduct, and reporting of the audit. This audit was performed together with an auditor from Grünenthal Corporate Quality Assurance.	Germany and other European countries
2006	Audit of Clinical Safety Service Provider for Biopartners	Led the preparation, conduct, and reporting of the audit.	Germany
2006	Review of the Medical Information Processes at provider contracted by Bayer Consumer Care Division	Led the preparation, conduct, and reporting of the audit.	UK
2006	Review of EU Drug Safety Processes at the European Drug Safety Unit at GPC Biotech	Led the preparation, conduct, and reporting of the audit.	Germany
2006	Audit of Clinical Safety Service Provider for BioVex	Led the preparation, conduct, and reporting of the audit.	UK
2005	Mock Inspection of Global Drug Safety (GDS), Bayer HealthCare AG	Led the preparation, conduct, and reporting of the audit. T. Hamard was the sole member of the audit team	Germany
2005	Audit of Pharmacovigilance Operations at the French subsidiary of Bayer HealthCare AG	Led the preparation, conduct, and reporting of the audit.	France
2005	Follow-up of EMEA Pharmacovigilance Inspection at the UK Drug Safety Unit of Schering-Plough	Consulting on the actions to complete in order to promote success of future inspections	UK
2005	Review of the Medical Information Processes at the Call Center contracted by Bayer Consumer Care Division	Led the preparation, conduct, and reporting of the audit. T. Hamard was the sole member of the audit team	UK
2004	Audit of Global Pharmacovigilance Unit of Altana Pharma	Led the preparation, conduct, and reporting of the audit. T. Hamard was the sole member of the audit team. The audit covered the activities of the Global Pharmacovigilance Unit of Altana Pharma, which also assumed the responsibility of Local Drug Safety Unit for Germany	Germany
2004	Audit of Pharmacovigilance processes at the OTC Products Division of Bayer	Led the preparation, conduct, reporting and follow-up of the audit	Germany, Spain and USA
2004	Audit of Pharmacovigilance processes at the Biological Products Division of Bayer	Led the preparation, conduct, reporting and follow-up of the audit	USA
2004	Audit of Pharmacovigilance processes at a partner company	Led the preparation, conduct, reporting and follow-up of the audit	UK
2003	Preparation, conduct & follow-up of local Pharmacovigilance Inspection	Led the preparation, attended the conduct and contributed to the follow-up for a MHRA Pharmacovigilance Inspection	UK
2002-2003	System audit of Global Pharmacovigilance Processes for Bayer	Led the preparation, conduct, reporting and follow-up of the audit	UK, USA, Germany, Italy, Spain, Mexico, Japan and China
2002	Follow-up of local Pharmacovigilance Inspection	Contributed to the identification of corrective actions	Portugal
2001	Preparation for local Pharmacovigilance Inspection	Supervised the preparation, conduct and reporting of a pre-inspection audit by a corporate auditor	USA
2001	Preparation for local Pharmacovigilance Inspection	Led the preparation and supervised the conduct and reporting of a pre-inspection audit by a contract auditor	France
2001	Preparation & follow-up of FDA Inspection at the corporate Pharmacovigilance department	Led the preparation, conduct and reporting of a pre-inspection audit	Germany
2000	Follow-up of local Pharmacovigilance Inspection	Involvement for corrective actions after inspection	The Netherlands

Other Experience

10 years of auditing experience

Pharmacovigilance and System Auditing:
Head, Global System Audit Management in Bayer for 4 years. Responsibilities included establishing this newly created function, leading global audit teams in the evaluation of product development processes, the identification of areas for improvement and the definition of corrective actions.

Clinical Quality Assurance and Investigator Site Auditing:
This included leading the design and global implementation of the procedures and tools to support all site audit activities, including a compliance data analysis and reporting tool to evaluate process performance. Leading the planning, conduct and reporting of study related audit activities for multiple clinical development projects. Managing the ISO 9000 certification process.

Global experience:
Held positions of increasing importance in France, Switzerland, the United Kingdom, the USA and Germany. Led audits for sites and systems throughout the world.