Franck SCHWARTZ

En résumé

Entreprises

• Novartis - Senior Compliance Professional - Compliance & Inspection - Pharma Auditing & Compliance QA

  RUEIL MALMAISON 2014 - maintenant • Execute complex GCP/PV compliance activities and trending activities as well as basic GMP compliance activities.
  • Conducts GCP/PV audits of areas with increased complexity, including “For Cause“ or “Data Integrity” driven audits utilizing advanced quality assurance techniques.
  • Support GCP/PV inspection readiness of the involved organizations and manage health authority interactions and follow-up.
  • Support strategic initiatives for continuous improvement.
  • Support upon request CSV/GMP audits.

• ANSM - Inspector – Trials and Vigilance Inspection Department

  Saint-Denis 2013 - 2014 Assess pharmaceutical companies’ compliance with French and EU legislation relating to the monitoring of the safety of medicines given to patients.
  • Conduct Pharmacovigilance inspections of Marketing Authorisation Holders to assess compliance with French and EU legislation relating to the monitoring of the safety of medicines given to patients for the French Regulatory Authority (ANSM) and on behalf of EMA.
  • Involve in the preparation of a risk based programme of routine Pharmacovigilance inspections.
  • Involve in the preparation of new and revised guidance on Pharmacovigilance inspection related topics, co-ordination of advice on the interpretation of Pharmacovigilance requirements and related technical issues.
  

• IPSEN - VP, Global R&D Quality

  Boulogne-Billancourt 2011 - 2013 Lead the Global R&D team to ensure that systems, processes and Quality Assurance programs are in place to meet ethical, regulatory requirements and business needs, to achieve company objectives and clinical excellence.
  • Improve and optimise the quality of systems in order to promote a high quality output, to support international product registrations.
  • Strengthen quality culture and awareness within R&D. Ensure an advisory role and develop training strategies.
  • proactively facilitate quality issue investigations using appropriate process improvement, risk based approach and problem solving techniques.
  • Advise, enable and influence senior executive management decision to ensure mitigation of Quality and Regulatory compliance risks.
  • Implement a regulatory inspection readiness program and worldwide compliance monitoring including audits, gap analysis, interview skills training and corrective and preventative actions (CAPA) follow up.
  • Development and management of an audit team. Implementation of a risk-based audit strategy to assess compliance risks and threats.
  • Provide oversight for implementing benefit risk process and governance.
  • Hosted more than ten Good Clinical Practice (GCP) and Pharmacovigilance sponsor regulatory inspections in EU and US.
  • Led more than 170 audits worldwide.
  

• Ipsen - Senior Director Safety and Compliance

  Boulogne-Billancourt 2008 - 2011 Leads the Ipsen Pharmacovigilance team based in UK and the Quality team based in France to ensure that:
  Pharmacovigilance operations consistently achieve excellent levels in the monitoring of company products safety, both during development and after marketing authorisation approval, in order to meet international regulatory requirements, and patient safety;
  Systems, processes and Quality Assurance programs are in place to meet ethical, regulatory requirements and business needs, to achieve company objectives and clinical excellence.
  • Responsible for providing strategic and functional leadership of the Drug Safety operations and Quality Assurance programs.
  • Improve and optimise the quality of systems in order to promote a high quality output, to support international product registrations.
  • Maintain an overview of the safety profile and emerging safety concerns for the products with a Marketing Authorisation.
  • Successfully internalise the signal detection activities and develop the signal detection strategies.
  • Review and streamline global safety processes and procedures for consistency and compliance with regulatory requirements and company policies.
  • Promote the development of performance metrics system to enable continuous improvement of Pharmacovigilance and Drug Development.
  • Set up the Quality and Safety Evaluation Board, to ensure Quality and Safety of company products through a thorough and simultaneous review of each product’s Safety and Quality profile.
  • Review and approve Pharmacovigilance and Safety Data Exchange Agreements with third party development and co-marketing partners.
  • Review and approve drug safety reports (PSUR, DSUR, ASR, REMS, and RMP) and CIOMS forms for expedited reports. Provide medical support and expertise to ensure drug safety reports are accurate, of high quality, submitted according to international regulatory requirements and timelines.
  

• Ipsen - Director of International Quality Assurance

  Boulogne-Billancourt 2000 - 2008 Management of an international Quality Assurance team to ensure the implementation and the coordination of Quality Assurance activities in Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) at the corporate level. Participate in ways of improving and optimising the quality of Drug Development processes in order to promote a high quality output to meet regulatory and business needs and to support international product registrations.
  • Optimisation and management of company Quality Management System. Develop audit plans and Quality Assurance strategies for R&D programs.
  • Expert in the development and management of GCP and Pharmacoviglance Quality Assurance systems with excellent skills in process mapping, writing of Standard Operating Procedures and systems integration.
  • Extensive experience in conducting audits of clinical trial systems and processes. Audits are including Contract Research Organisations, software vendors, partners, investigatotional sites, phase I units, data management processes, databases, statistical analysis, clinical study reports, laboratories, regulatory submissions and computerized systems.
  • Successful strategic investigational site and sponsor FDA inspections preparation of a New Drug Application in 2007 and a Biologic Licence Application in 2008.
  • Strong understanding of current computerised system validation, GAMP5 and FDA 21 CFR part 11.
  • Team development and training.
  

• Ipsen - Head of Quality Assurance

  Boulogne-Billancourt 1995 - 2000 Management of a local Quality Assurance team to implement Quality Assurance activities in GCP including audits, Standard Operating Procedures and quality improvements.

• Ipsen - Clinical Project Manager

  Boulogne-Billancourt 1992 - 1995 Management and coordination of international clinical studies

• ITEM (Clinical Research Organisation) - Clinical Project Manager

  1991 - 1992 Management and coordination of international clinical studies.

• General Medical Practitioner - General Medical Practitioner

  1989 - 1991

Formations

• Université Paris VI Faculté De Médecine Saint Antoine

  Paris 1978 - 1989 Medical Doctor

Réseau

• Alexandre LEOPOLDES

• Atlan PATRICK

• Audrey MANDON PETTIER

• Laurent FLIPO

• Marie-Sophie CAMUS

• Nicolas FORTE

• Nicolas PHILIPPE

• Patricia DELAHAYE

• Romain DENEFLE

• Steve CANAS