arnaudchavanon

Arnaud Levain Chavanon

Managing Director

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Arnaud is Pharm D. and holds a Master's Degree in Quality Assurance. He has lived in several countries (France, United Kingdom, Belgium, and Switzerland) and has been in the GCP environment for over 20 years working for major pharma companies such as Novartis, Bayer, Wyeth, UCB and Celgene.

Arnaud has conducted 200+ audits, has managed dozens of Health Authority inspections and has been a leader in enhancing clinical processes in various organizations.

In 2016, Arnaud decided to leave Celgene where he was Clinical Quality Assurance Director in the Clinical Quality Assurance department to become a consultant. He has since completed a variety of projects such as gap analyses, GCP audit programs, GCP training sessions, SOP development, and GCP consultancy, for multiple customers around the globe.

Place of birth:
Paris, France
Background:
Pharm D. (René Descartes University, Paris)
Master degree in Quality Assurance (René Descartes University, Paris)
Previous jobs:
CRA (Novartis, France)
GCP Global Auditor/GCP expert (Bayer, France and UK)
GCP International Auditor (Wyeth, France)
Corporate audit Manager (UBS, Belgium)
Director Clinical Quality Assurance (Celgene, Switzerland)
Health Authority inspection support:
FDA, EMA, ANSM, BFARM, Infarmed, SwissMedic, MHRA
Number of audits performed:
+ 300
Number of countries where audits were conducted:
35
ludovicmoulin

Ludovic Moulin

Managing Director

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Ludovic has worked in the field of Quality Assurance for over 15 years. First starting in the GMP/GLP area in a Pharmaceutical Microbiology lab, he then moved to GCP to broaden his knowledge quality assurance principles. After working for five years in Canada, he relocated to Switzerland to join the Clinical Quality Assurance department of Celgene where he became an Associate Director and Program Lead.

Throughout the years, Ludovic has supported many Health Authority inspections across the globe and was entrusted to perform audits in America, Europe, and Asia. Amongst his peers, Ludovic is appreciated for his leadership, interpersonal skills, communication skills, and business acumen.

Place of birth:
Montreal, Canada
Background:
B.Sc Microbiology and Immunology (Université de Montréal)
Graduate certificate in Management (HEC Montréal)
M.A. International Relations (Freie Universität Berlin)
Previous jobs:
Microbiologist (Bodycote Materials Testing, Laval Canada)
GCP auditor (Labopharm, Laval, Canada)
Associate Director Clinical Quality Assurance (Celgene, Boudry Switzerland)
Health Authority inspection support:
FDA, EMA, Health Canada, CFDA, KFDA, ANSM, BFARM, ANVISA, URPL, SUKL, Infarmed, SwissMedic, MHRA.
Number of audits performed:
+ 150
Number of countries where audits were conducted:
23
petrasicher

Petra Sicher

Head of GCP audits and inspections

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Petra is a physician by education and worked in geriatrics, neuro-rehabilitation, palliative care, psychiatry and psycho-oncology. 15 years ago she changed to clinical research, first as Medical Reviewer before switching to Quality Assurance. Petra she has conducted over 200 GCP audits, led multiple inspection readiness activities as well as compliance training activities.

In addition to her experience in Biotech companies, she also has worked with cooperative groups thus bringing to the team some expertise closer to the academic research.

Place of birth:
Switzerland
Background:
M.D (University of Bern)
Previous jobs:
Associate Director Molecule Quality Lead (BMS)
Senior GCP auditor (Celgene)
Head of Quality Assurance (European Thoracic Oncology Platform)
Head of Quality Assurance (International Breast Cancer Study Group)
Health Authority inspection support:
FDA MHRA SwissMedic KFDA PMDA
Number of audits performed:
+ 200
Number of countries where audits were conducted:
24
mariasliwowska

Maria Sliwowska

Head of pharmacovigilance and data protection services

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Maria is a physician by education, holds a degree in epidemiology, and is currently certified as Information Privacy Professional/Europe (CIPP/E). For the past 20 years, she has worked in various Quality Assurance roles across GCP, GCLP, GVP, CSV and data privacy and advanced analytics space.

Maria has worked for Biotech companies, big pharmas, clinical research organizations, and non-governmental organizations. In addition to this, Maria has been involved in various professional organizations to promote quality and good practices.

Place of birth:
Poland
Background:
M.D (University of Bern)
Previous jobs:
Global Head of Data Analytics and Insights (Roche)
Team Lead GxP auditing (Roche)
Quality Manager (Medicines for Malaria Venture)
Associate Director Quality Assurance (PRA)
Health Authority inspection support:
FDA MHRA SwissMedic KFDA
Number of audits performed:
+ 400
Number of countries where audits were conducted:
25
bipinpatel

Bipin Patel

Quality Expert, APAC representative

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Bipin is an experienced, qualified Quality Assurance (QA) professional in the field of pharmaceutical and medical device consultancy. He has over 20 years of experience working in the US, European and Indian industry with wide experience in performing and managing clinical QA programs, Quality Management Systems, CAPA programs, and regulatory compliance. Bipin acts as ObelysQ’s representative for all activities in the APAC region.

Bipin has conducted more than 400+ Good Clinical Practices (GCP) and Computer System Audits in more than 20 countries in Asia, Africa and EU regions, and was involved in many Health Authority inspections. Bipin uses his global expertise and multi-cultural exposure to provide cost effective services to my clients in the health sciences industry.

Place of birth:
India
Background:
M. Sc Pharmacy (Gujarat University)
Previous jobs:
Self-employed consultant (RS Serve/GxP Qualitas)
Quality Manager (inVentiv Health Clinical)
Quality Assurance Manager (Servier)
Health Authority inspection support:
DCGI, MHRA, FDA, EMA, TFDA. Vietnam MoH, KFDA, ANVISA, WHO, MCC, and Israel MoH
Number of audits performed:
+ 400
Number of countries where audits were conducted:
+ 20