CV – VivHo

Education

VWO Bernardinus College /Netherlands / 1988
Healthsciences University of Maastricht / Netherlands /1989 (bridging year)
Internship Pediatrics & Genetics, University of Oxford -UK /1995
Flexibel MD degree (MSc) in pediatrics, gynaecology / and genetics Universityof Maastricht – Netherlands /1996
Traditional MD degree University of Maastricht- Netherlands /1999
Registered Clinical Pharmaceutical Physician (NVFG) – Netherlands /2002
PhD degree Universtiy of Maastricht – Netherlands / 2004
Registered Physician at the Orde Der Geneesheren – Belgium / 2010
CPI (ACRP) – USA / 2011/2013/2015/2017/2019
ACRP-PM – USA / 2019
FDA training for investigators in clinical research – USA /2013
Design and Interpretation of Clinical trials – Johns Hopkins/Coursera – USA /2014
Introduction to Pharmacy – Ohio State University/Coursera – USA / 2014
FAPCR – USA / 2016/2018/2020

Career

PhD in Paediatrics /University of Maastricht / 2004 A PhD research on auxology in 1234 infants
Research Physician / independent research site PreCare / 1999-2004 Research physician and PI for clinical trials phase II, III and IV
District Manager / independent research site PreCare / 2000
Research physician, PI, project manager, for clinical trials phase II, III and IV
People management, access to patients, feasibilities
Medical Director / independent research site PreCare / 2001-2004
Research physician, PI, project manager, budgeting for clinical trials phase II, III and IV, people management, access to patients, feasibilities, educating, protocol developments
Senior Consultant at KHG consultancy / 2004 – 2014
All round consulting activities within the pharma/CRO industry, medical setting, teaching at academic and college of higher education (hoge school).
Founder, owner and director / independent research site PT&R / since 2004
Entrepreneur, physician, PI, all round manager
Founder, owner and director / VivHo – VivMedical-Consulting/ since 2013
Medical consultant in Life Sciences for a.o. Quintiles, MSource, Astellas, Nutricia, Nubellum Research.

Consulting activities

Independent physician for clinical trials (The Netherlands)
Acting as an independent physician for various clinical trials conducted at hospitals, research sites and SMOs in The Netherlands in various medical indications for all phases of clinical trials
Medical translator / Medical reviewer (The Netherlands and Belgium)
Review of trial documents for patients that were going to be used in clinical trials and submitted to IRBs. This included but is not limited to ICF, advertisement, brochures, druglabels, diaries
Feasibility consultant for Pharma and CROs (The Netherlands and Belgium)
Perform feasibilities for new potential clinical trials describing access to patients, recruitment strategies, site strategies and market access for all phases of clinical trials
Feasibility manager for Quintiles NV, alarge multinational CRO (Belgium).
For 10 years performing all feasibilities, internal and external capabilities and landscape assessments for potential upcoming trials by liaising with physicians including KOLs, mostly phase I, II and III
Protocol reviewer for Pharma and CROs (The Netherlands and Belgium)
Review of protocols for feasibility, access to patients, determine bottlenecks and challenges, comparing to SOCs, all phases of clinical trials
Protocol (co)writer for Pharma and CROs (The Netherlands and Belgium)
(Co)developing protocols for clinical trials phase II, III, IV/PostMarkerting
eDC beta-tester (Belgium, The Netherlands and USA).
Testing of eDCs from various vendors, for a specific clinical trial from a site’s perspective
Clinical (trial)portal advisor and betatester (Belgium, The Netherlands and USA)
Testing of Portal that will be implemented in clinical trials for userfriendliness from a site’s perspective
eTools / ePRO advisor and beta-tester (Belgium, Germany, The Netherlands and USA)
Testing and advising the use and development of etools i.e. eportals, ediary, trialslides, BYOD on userfriendlyness for sites and patients. Developing of a certifications program for sites.
CRA trainer for Pharma and CROs (Belgium, Germany and The Netherlands)
Developing training material and educating CRAs and other clinical operation staff members on, but not limited to: interpretation of lab results, documentmanagement in clinical research, introduction into clinical research, GCP, SOPs and Quality, How to read a protocol, Etools in clinical research, Budgetting, Feasibilities in clinical research, Site-Sponsor cq PI-CRA relationship and communication.
University Teacher post doc education on clinical research (UZ Antwerp)
Developing training material and educating students on SOPs development and quality in clinical research
Exam commission eBROK / GCP (The Netherlands)
(Co)-developing new casus and questions for the national exam and assess appeals from exam candidates on exam questions.
Ambassador for GCPCentral (The Netherlands)
The site’s perspective on GCP training
Independent consultant for the Non WMO clinical trial evaluation program (The Netherlands)
Acting as an independent consultant for the working group and IRBs in the pilot fase of implement the new guidelines on Non-WMO clinical trials
Within the SCRS participating in various SAG for CRO’s, vendors and TransCelerate
Senior Dara Assurance and Medical Consistency Manager PV – Astellas (The Netherlands)
Director of Education – SCRS (USA)
Medical Monitor – Danone (The Netherlands)
CMO – Nubellum Research (USA)

Memberships

Register of Clinical Pharmacological research physician / Netherlands
ACRP / USA
APCR / USA
NVFG / Netherlands
SCRS / USA
ACRON / Netherlands

Executive Functions

(Medical) Director and owner of the independent research site PT&R
NVFG: chairperson communication commission,
NVFG: vice-president of the board of the NVFG
NVFG: member of the Clinical Operations Working group
eBROK/GCP: member of the national examination commission
SCRS: Initiator and leader of the White Paper on Feasibility Streamlining
SCRS: Member of the Leadership Council
SCRS: Site Solutions Summit advisory board (both USA and EU)
SCRS: President EU Site Solution Summit

Research & Trial experience as PI / physician

L’ Aemi; anthropometry in infants / 1993-2004
Acne / 2000 – 2003
Allergies / 2007-2011, 2017 – 2020
Alopecia / 2002
Alzheimers Disease / 2019 – 2020
Anthropometry of children and adolescents AZM / 1995-1999
Anticonception / 1998-2016
Arthritis / 2019 – 2020
Asthma / 2011 – 2018
BPH / 2006, 2007, 2013 – 2014
Cardiovasculair (non interventional)/ 2003 – 2020
Circumcision / 1998, 1999
COPD / 2008 – 2019
COVID-19 & Corona / 2020
Dermatitis / 2007 – 2019
DM type II / 2000 – 2014
DM type II in adolescent / 2003
DUB / 2006-2009, 2013
Dyspepsia / 2012 – 2014
Endocrinology / 1999 – 2019
Fibromyalgia / 2014 – 2016
FSAD / 2002, 2007
Hypercholesterolemia / 1999 – 2020
IBS / 2001-2009, 2013 – 2014
Infectious diseases (including vaccinations) / 2004 – 2010
Influenza / 1999 – 2010
Hypertension /1999 – 2014
Hypogonadism / 2006
HRT / 1999 – 2007
Neuropathy / 2013 – 2014
Obesity / 2007 – 2014
Obstipation / 2012 – 2013
Osteoarthritis /2001 – 2009
Osteoporoses / 1999 – 2019
PE / 2005
PMDD / 2001, 2002
Psoriasis/ 1999 – 2020
Rheuma / 2002, 2003
Rhino Pharyngitis & Sinusitis / 2000 – 2003 & 2009 – 2010
Vaccination / 2007 – 2009

Additional Education, Trainings & Certifications

English Communication Course for the Medical Faculty / 1991
Summercourse Burns and Children at Beverwijk / 1992
Einführung in die Klinische Medizin at Aachen / 1993-1994
Elective Pediatrics at the university of Oxford; Racliff Hospital / 1995
Elective Genetics at the university of Oxford; Churchill hospital / 1995
Diploma of the Dutch Foundation for Sportmassage / 1995
7th HGH Symposium in Madrid / 1996
Summer-course Physical Anthropology at the university of Leiden / 1996 under the auspices of Dr. G.J.R. Maat
10th Congress of the European Anthropological Association / 1996 at Bruxelles
Selection-education laboratory training genetics MCB & Genetics / 1997 / at Maastricht
Boerhaave-course: TNO/LUMC symposium: The Fourth National / 1998 / Growthstudy
PhD-research Pediatrics / 1993 – 2004 / A SMILE: Anthroplogical Survey of Maastricht Infants Longitudinaly Evaluated
Training Quality and Dutch requirements related to Clinical Drug Research / Profess Medical Consultancy BV / 1999
Symposium Law Medical Scientific / research with people (WMO) / 1999
Inhouse GCP course given by Profess Medical Consultancy BV / 2000 and 2005
Training Dependency and influence related to clinical drug research/ Profess Medical / Consultancy BV / 2000
Evening workconference New Dutch Regulatory Requirements / Profess Medical Consultancy BV / 2001
Beyond the informed consent / 2001 / Training by Bayer institute for HealthCare Communication
DEXA training for Hologic QDR 1000 / 2001
Boerhaave-course: ECG reading and interpretation / 2002
GCP for site coordinators & CRA’s / Training Days – Erik Klaver / 2003
SOP’s in CRO / Q University / 2004 – 2014
CRA training / Q University / 2003
Financial management / Q University / 2003
ECTD / Q University / 2004
Introduction in Complaints Management / Q University / 2004
Goal Setting / Q University / 2004
Problem Solving / Q University / 2004
Signature irregularities and fraud / Q University / 2004
GMP / Q University / 2004
Boerhaave-course: Stralingshygiene 4A/M (radiation hygiene) / 2005
DEXA training for Hologic QDR 4500 / 2005
Lab in clinical trials / 2005 / certificate and trainer
GCP training at all investigators meetings / 1999-2014
GCP Q University / 2008-2014
GCP etraining NovoNordisk / 2008-2011
IATA / 2012 / 2019
Various GCP trainings / exams (at least once a year) / 2000-2014
Barnet GCP exam / 2013
Barnet GCP exam for CROs / 2013
Barnet GCP exam for CROs / 2014
ECG reading and interpretations / 2014
Pulmonology tests and interpretations / 2014
Update GCP / WMO / 2017
GCP 2019
Comfort Talk / VHYP.be 2019 – 2020
GCP / ACRP 2020

Publications & Presentations

on request (info@vivho.com)