Speakers

Michele Garot

Michele Garot

Managing Director and Owner of CLINCellence (Belgium)

Michele Garot is Managing Director and Owner of CLINCellence, consultant in the field of Clinical Operations, GCP / Quality and Risk Based Quality Management.

 

Michèle build credibility and expertise working during more than 25 years in Clinical Research in Pharmaceutical Organisations (GSK & UCB) and lately CRO (Quintiles).

 

She joined Quintiles in 1997 as Director Clinical Operations Belgium expanding her role as Executive Director in European and Global Operations.

She developed passion in global quality initiatives and in 2011, she established the group of Western Quality Management. Since then, her primary focus has been on GCP compliance, audit and inspection CAPAs, recovery and improvement, and she acted as senior representative in assorted Quintiles and Customer governance committees.

She also acted as Global Project Lead for many very large scale corporate initiatives.

Lately, she added another dimension to her activities, interactions with external parties (e.g. European Agency) and working groups / forums with regard to the RBQM guidance and the Clinical Trial Regulation.

 

Medical Doctor by education,  she obtained a degree in Business and Administration and joined the Pharmaceutical Industry holding various positions: Pharmacovigilance with SmithKline Biologicals , Head respectively Data Management and Medical Regulatory Affairs at UCB Headquarters.

She is Board member in BeCRO (Belgian assoc.  of CROs) also acting in the European CRO Federation (EUCROF), Board member of EFGCP and ACRP. She is chair of the program committee for EUCROF European Clinical Research conferences and is lecturer in Clinical forums & program development training in Clinical research.