Dirk W. Meijer, CEO
, has over fifteen years of experience in the design and analysis of clinical trials and European regulatory affairs of Medical Devices. He holds a M.D. and a Ph.D. in medicine from the University of Amsterdam and a M.Sc. in epidemiology and bio-statistics from Erasmus University in Rotterdam. He has published numerous publications in medical journals and has given numerous presentations to professional societies. Dr. Meijer is a member of the European Association for Endoscopic Surgery, and the Regulatory Affairs Professionals Society. He is the Editor of technicology section for the Journal of Laparo-Endoscopic Surgery and Surgical Endoscopy. Currently he is treasurer of the European Association for Endoscopic Surgery.

 

 

 

 


Joris Bannenberg, COO
, is a medical doctor with a PhD in surgical techniques. He has over 15 years of experience with medical devices in experimental and clinical trials, surgical procedures and clinical trials for medical devices. He has trained over 2500 surgeons in many minimal invasive surgery courses. As medical director/consultant he is responsible for medical device studies in several medical specialty fields for various medical device companies, from small companies to multi-nationals. He was one of the founders and presidents of the ACRP Europe and a member of the ABOT (board of directors) of the ACRP in 2001-2002.

 

 

 

 


Hanny Vlaskamp, Quality Consultant
is a consultant to the pharmaceutical and medical device industry. In conjunction with Factory she works quality improvement projects and audits. She also organizes in-company trainings on ICH GCP, local law, and the company SOPS.

 

 

 

 

 


Alita Sluimer, QA Manager

 

 

 

 

 


Maritza Witteveen, Clinical Data Manager
. Over 5 years of experience in Clinical Data Management. Before that, she gained experience in SAS programming as a Statistical Programmer within a Biometrics team. She is responsible for timely, quality data management. She is convinced that the first guarantee to obtain quality data management is quick feedback to recorded data. In other words; speed in data processing.

To download the programme WS04104 “Three Worlds – One Voice” please Click here

 

 

 

 

 


Marianne de Man, Senior CRA
, has many years of practical experience in coordinating and performing clinical studies for medical devices in various fields. She has a university degree in Medical biology and knowledge and practical experience in the application of European and FDA regulations (EN540 and ICH-GCP) for medical device studies

 

 

 

 

 


Loes Leeuw, Project Coordinator
, has over 5 years experience in organizing small projects and big events. She coordinates the activities of all team members, highlights resource needs and monitors project progress while trials are proceeding.

 

 

 

 

 


Pascal Groenen, Clinical Data Manager
. Following his studies Biomedical Health Sciences he conducted a 4 year clinical study on the subject of Spina Bifida and Nutritional and Environmental Factors which resulted in a PhD in Medical Science. During these studies he gained experience in the setting up and managing of clinical studies, but also SAS programming and statistical analysis. Before starting at Factory CRO he worked with a medium-sized pharmaceutical company. He believes that quality data management is reached by standardization of collection, exchange and submission of clinical data.