This curriculum vitae summarizes Marie-Noëlle Debelle's education and 30 year career in the pharmaceutical industry. She holds a Master's degree in Biology from the Catholic University of Louvain and has worked at GlaxoSmithKline since 1987, holding various quality assurance and risk management roles ensuring regulatory compliance. Her experience includes training, developing standard operating procedures, and preparing for and managing audits and inspections.
Marie-Noëlle Debelle's curriculum vitae outlines her educational background including a Master's in Biology from the Catholic University of Louvain and over 30 years of experience in the pharmaceutical industry, primarily at GlaxoSmithKline Biologicals where she has held several senior management roles focused on quality, risk management, and regulatory affairs.
The document discusses risk management for pharmaceutical projects. It begins by outlining the characteristics of the pharmaceutical industry and drug development process. The drug development process takes an average of 10 years and $2.6 billion to develop a new drug. The presentation then covers risk management processes, tools and techniques for identifying, analyzing, and responding to risks in drug development projects. A case study on risk assessment for product development is presented to demonstrate how to evaluate risks and prioritize mitigation actions.
Dear all,
I have tried putting down my view-points on benefits of Project Management system in Pharmaceutical Industry...
Please let me know what do you think.
Regards,
Megha Thakkar
Supply chain risk management (SCRM) is "the implementation of strategies to manage both everyday and exceptional risks along the supply chain based on continuous risk assessment with the objective of reducing vulnerability and ensuring continuity".
SCRM attempts to reduce supply chain vulnerability via a coordinated holistic approach, involving all supply chain stakeholders, which identifies and analyses the risk of failure points within the supply chain. Mitigation plans to manage these risks can involve logistics, finance and risk management disciplines; the ultimate goal being to ensure supply chain continuity in the event of a scenario which otherwise have interrupted normal business and thereby profitability.
£1,000.00
Manager: £1,500.00
Strategic Consultant
£1,500.00
Medical Consultant
£1,500.00
Legal Consultant
£1,500.00
Communication Consultant
£1,500.00
Project Manager
£1,000.00
Administrative Support
£500.00
08/02/2014 confidential
35
Our Costing Procedure
1. Initial meeting to understand the need
2. Proposal of the appropriate level of advice
3. Estimate of required time and team
4. Costing based on our grid
5.
The document provides information about a postgraduate diploma in project management offered through a partnership between AUB Continuing Education Center and CMCS Lebanon. The diploma aims to meet the growing demand for skilled project managers in the MENA region. The curriculum covers project, program, portfolio, and risk management taught by experienced practitioners. Courses are delivered once a month for three days similar to executive MBA programs. The diploma also provides opportunities to apply for several international certifications. The document lists instructor profiles and provides contact information for the program.
The National Service Framework for Quality Improvement aims to transform patient care and public health by putting knowledge to work. It provides quality assurance, management, and control for library services through national standards and developmental standards. The framework is aligned with national policy and contains five domains and outcomes to ensure high quality, consistent library services across the country. It will be implemented through self-assessment, peer review, and compliance with essential, core and developmental criteria.
Nancy MacDonald has over 11 years of experience in clinical trial administration. She has extensive experience managing clinical trials and ensuring compliance with regulations. Her skills include clinical trial coordination, document management, training junior staff, and acting as a liaison between study teams and clients. She is proficient in common software programs and clinical trial management systems.
Marie-Noëlle Debelle's curriculum vitae outlines her educational background including a Master's in Biology from the Catholic University of Louvain and over 30 years of experience in the pharmaceutical industry, primarily at GlaxoSmithKline Biologicals where she has held several senior management roles focused on quality, risk management, and regulatory affairs.
The document discusses risk management for pharmaceutical projects. It begins by outlining the characteristics of the pharmaceutical industry and drug development process. The drug development process takes an average of 10 years and $2.6 billion to develop a new drug. The presentation then covers risk management processes, tools and techniques for identifying, analyzing, and responding to risks in drug development projects. A case study on risk assessment for product development is presented to demonstrate how to evaluate risks and prioritize mitigation actions.
Dear all,
I have tried putting down my view-points on benefits of Project Management system in Pharmaceutical Industry...
Please let me know what do you think.
Regards,
Megha Thakkar
Supply chain risk management (SCRM) is "the implementation of strategies to manage both everyday and exceptional risks along the supply chain based on continuous risk assessment with the objective of reducing vulnerability and ensuring continuity".
SCRM attempts to reduce supply chain vulnerability via a coordinated holistic approach, involving all supply chain stakeholders, which identifies and analyses the risk of failure points within the supply chain. Mitigation plans to manage these risks can involve logistics, finance and risk management disciplines; the ultimate goal being to ensure supply chain continuity in the event of a scenario which otherwise have interrupted normal business and thereby profitability.
£1,000.00
Manager: £1,500.00
Strategic Consultant
£1,500.00
Medical Consultant
£1,500.00
Legal Consultant
£1,500.00
Communication Consultant
£1,500.00
Project Manager
£1,000.00
Administrative Support
£500.00
08/02/2014 confidential
35
Our Costing Procedure
1. Initial meeting to understand the need
2. Proposal of the appropriate level of advice
3. Estimate of required time and team
4. Costing based on our grid
5.
The document provides information about a postgraduate diploma in project management offered through a partnership between AUB Continuing Education Center and CMCS Lebanon. The diploma aims to meet the growing demand for skilled project managers in the MENA region. The curriculum covers project, program, portfolio, and risk management taught by experienced practitioners. Courses are delivered once a month for three days similar to executive MBA programs. The diploma also provides opportunities to apply for several international certifications. The document lists instructor profiles and provides contact information for the program.
The National Service Framework for Quality Improvement aims to transform patient care and public health by putting knowledge to work. It provides quality assurance, management, and control for library services through national standards and developmental standards. The framework is aligned with national policy and contains five domains and outcomes to ensure high quality, consistent library services across the country. It will be implemented through self-assessment, peer review, and compliance with essential, core and developmental criteria.
Nancy MacDonald has over 11 years of experience in clinical trial administration. She has extensive experience managing clinical trials and ensuring compliance with regulations. Her skills include clinical trial coordination, document management, training junior staff, and acting as a liaison between study teams and clients. She is proficient in common software programs and clinical trial management systems.
Andrejs Faibusevics has over 11 years of experience in clinical research, most recently as a Regulatory Start-Up Manager at Quintiles. He has significant experience managing global and regional clinical trials in various therapeutic areas including influenza, HIV, diabetes, and osteoporosis. His responsibilities have included regulatory start-up activities, clinical operations management, site monitoring, and ensuring compliance. He holds an MD from the Latvian Medical Academy.
This document provides a summary of Darral Addison's qualifications and experience. It includes over 20 years of experience in clinical, pharmaceutical, biotech, medical device, food and IT industries, with strong communication and regulatory skills. Addison has held roles at various companies focused on quality assurance, validation, clinical trials, and project management. He has a background in chemistry and quality systems with various industry certifications and a master's degree.
Dina Ahmed Ismail Eldaour seeks a position where she can utilize her skills and experience in medical affairs, compliance, and team leadership. She has over 20 years of experience in medical affairs roles at AstraZeneca, managing medical teams across the Middle East and Africa regions. Her experience includes managing medical information, compliance functions, non-interventional studies, and patient safety. She has strong leadership skills and experience developing medical strategies aligned with organizational objectives.
This document provides a summary of Medhat Gamal Abdel Ghafour Mohamed's professional experience and qualifications. He has over 27 years of experience in clinical risk management, patient safety, and quality management. His most recent role was as Clinical Risk Manager at Al Noor Specialist Hospital in Makkah, KSA, where he implemented a hospital risk management program. Prior to that, he held several director roles focused on quality assurance, patient safety, and occupational health. He has a Master's Degree in Environmental and Occupational Medicine from Cairo University and several professional certificates in areas like clinical risk management and hospital administration.
This document summarizes Dr. Pamela Hepple's presentation on WHO's Better Labs for Better Health initiative. The initiative aims to strengthen national laboratory systems through improved policies, training, quality management, and infrastructure. It coordinates efforts across countries using international standards. Activities include training over 135 laboratory managers in quality systems and mentoring 24 countries as they implement quality management. The mentoring program supports laboratories in becoming accredited and building trust. Upcoming events will report on progress and share best practices between countries and partners supporting this work.
□ Credit Card
□ Bank Transfer
□ Cheque
(4% surcharge for credit card payments)
Card No:
Expiry Date:
Security Code:
Cardholder's Name:
Cardholder's Signature:
Cardholder's Address:
Cancellations: Received in writing (letter or fax) up to 90 days prior to the event will be subject to a
10% administration fee. Refunds are not possible for cancellations received after this date.
Non-payment: If payment is not made at the time of booking, then invoice will be issued. We reserve
the right to charge credit card details provided at time
Gina Diguglielmo has over 30 years of experience in clinical research and operations management. She has managed budgets up to $10 million and trials with over 1,300 patients. As an independent consultant, she provides expertise in areas such as project management, budgeting, and process improvement. Previously, she held director-level positions at Novartis and other large pharmaceutical companies where she led global process improvement initiatives reducing time and costs.
The document provides a summary of Dawn Marie Rady's skills and experience. It includes 3 paragraphs:
1) Her objective is to lead a large patient-centered service group and provide high quality care. She has skills in management, training, care management, and quality improvement.
2) She has a Bachelor's in Nursing and is licensed in Wisconsin. Her education includes a nursing degree from Marian College.
3) Her experience includes over 15 years in quality improvement and management roles for health insurance and hospital organizations, where she improved processes, oversight programs, and patient outcomes.
This document is a curriculum vitae that provides biographical information about Mohammad Jamil Ahmad Salim. It includes details about his education, certifications, goals, experiences, and courses attended. He has a Bachelor's degree in nursing from Jordan University of Science and Technology and a Master's degree in medical laboratory science from the same university. His experiences include working as a quality consultant, training manager, and nursing supervisor at various healthcare organizations in Jordan. He has numerous certifications in areas like emergency medical training, auditing, and healthcare accreditation.
Shafik Janhangeer is a British national with over 14 years of experience in construction safety management in Qatar and other countries. He has a Master's degree in environmental science and is a Chartered Member of the Institute of Occupational Safety and Health. Currently he is an HSE Supervisor on the massive Lusail City development project in Qatar, where he has successfully implemented safety programs and achieved a zero-incident record over 5 years. He seeks to leverage his expertise in developing and enforcing strong HSE policies and systems to reduce risks and ensure compliance.
This document is a resume for Bangaly Keita that highlights their experience and qualifications. Keita has over 10 years of experience in both project management and healthcare administration. They are currently a Senior Project Manager overseeing projects aimed at optimizing financial processes in healthcare organizations. Previous roles include Project Manager, Healthcare Administrator, and Registered Nurse. Keita has a background of successfully implementing improvements in efficiency, quality of care, and cost savings across several healthcare organizations.
This document provides guidance for developing clinical practice guidelines at the Royal Children's Hospital in Melbourne, Australia. It outlines a 17 step process for guideline development that involves identifying a topic, forming an authoring team, reviewing evidence, drafting content, obtaining stakeholder feedback, finalizing and approving the guideline, implementing it, and evaluating its impact. Key principles include developing guidelines through a multidisciplinary process, basing them on the best available research evidence, and involving consumers throughout. The overall goal is to improve healthcare quality and outcomes for patients.
Lorrie Manacchio has over 30 years of experience in manufacturing, operations management, training, and quality assurance. She is currently a Senior Manager of Operations and interim Packaging Manager at AstraZeneca, where she oversees packaging operations and ensures adherence to schedules, training, safety, and performance targets. Prior to this role, she held various management positions at Johnson & Johnson, Pfizer, GlaxoSmithKline, and other organizations, where she improved processes, reduced deviations, and developed her team members. She holds a Green Belt certification from Villanova University and degrees in Chemistry and Medical Technology.
Erin Diaz has over 20 years of experience in healthcare IT and clinical analysis, with a focus on Allscripts SCM implementations over the past 10 years. She currently works as a Clinical Analyst III at New York Presbyterian Hospital, where her responsibilities include successfully implementing EMR systems, compiling technical specifications, and serving as an IT representative on multiple committees. Prior to this role, she held several sales, marketing, and operations positions in the diagnostic imaging field, consistently exceeding goals and improving operations.
Jess Mc Govern has 3 years of experience in a GMP laboratory, including method development, validation, equipment qualification, data review, and training. They hold a BSc in Industrial Biochemistry and are proficient in analytical techniques like HPLC, GC, and UV/Vis. In their current role at Eurofins Lancaster Laboratories, they perform pharmaceutical analysis, write reports, and assist in management responsibilities. They are organized, a strong communicator, and enjoy artistic pursuits and traditional Irish music in their free time.
This document provides a summary of Chris Bolam's qualifications, experience, and skills in risk management and health and safety. It includes his contact information and 20 years of experience in these fields across various industries. Key achievements highlighted include implementing risk registers and assessments, leading risk management strategies and policies, and managing teams. Skills include audit, project management, cultural change, and training. Recent roles include Health and Safety Manager at Manchester Metropolitan University from 2011-2016.
TranScrip provides services across the pharmaceutical development lifecycle including translational medicine, clinical development, regulatory affairs, medical affairs, drug safety, and portfolio management. They help biotech and pharmaceutical clients address challenges and achieve their drug development and commercialization goals. Their teams integrate seamlessly with clients and provide expertise, oversight, and flexible support to maximize opportunities and reduce risks throughout the drug development process from early research through commercialization.
Andrejs Faibusevics has over 11 years of experience in clinical research, most recently as a Regulatory Start-Up Manager at Quintiles. He has significant experience managing global and regional clinical trials in various therapeutic areas including influenza, HIV, diabetes, and osteoporosis. His responsibilities have included regulatory start-up activities, clinical operations management, site monitoring, and ensuring compliance. He holds an MD from the Latvian Medical Academy.
This document provides a summary of Darral Addison's qualifications and experience. It includes over 20 years of experience in clinical, pharmaceutical, biotech, medical device, food and IT industries, with strong communication and regulatory skills. Addison has held roles at various companies focused on quality assurance, validation, clinical trials, and project management. He has a background in chemistry and quality systems with various industry certifications and a master's degree.
Dina Ahmed Ismail Eldaour seeks a position where she can utilize her skills and experience in medical affairs, compliance, and team leadership. She has over 20 years of experience in medical affairs roles at AstraZeneca, managing medical teams across the Middle East and Africa regions. Her experience includes managing medical information, compliance functions, non-interventional studies, and patient safety. She has strong leadership skills and experience developing medical strategies aligned with organizational objectives.
This document provides a summary of Medhat Gamal Abdel Ghafour Mohamed's professional experience and qualifications. He has over 27 years of experience in clinical risk management, patient safety, and quality management. His most recent role was as Clinical Risk Manager at Al Noor Specialist Hospital in Makkah, KSA, where he implemented a hospital risk management program. Prior to that, he held several director roles focused on quality assurance, patient safety, and occupational health. He has a Master's Degree in Environmental and Occupational Medicine from Cairo University and several professional certificates in areas like clinical risk management and hospital administration.
This document summarizes Dr. Pamela Hepple's presentation on WHO's Better Labs for Better Health initiative. The initiative aims to strengthen national laboratory systems through improved policies, training, quality management, and infrastructure. It coordinates efforts across countries using international standards. Activities include training over 135 laboratory managers in quality systems and mentoring 24 countries as they implement quality management. The mentoring program supports laboratories in becoming accredited and building trust. Upcoming events will report on progress and share best practices between countries and partners supporting this work.
□ Credit Card
□ Bank Transfer
□ Cheque
(4% surcharge for credit card payments)
Card No:
Expiry Date:
Security Code:
Cardholder's Name:
Cardholder's Signature:
Cardholder's Address:
Cancellations: Received in writing (letter or fax) up to 90 days prior to the event will be subject to a
10% administration fee. Refunds are not possible for cancellations received after this date.
Non-payment: If payment is not made at the time of booking, then invoice will be issued. We reserve
the right to charge credit card details provided at time
Gina Diguglielmo has over 30 years of experience in clinical research and operations management. She has managed budgets up to $10 million and trials with over 1,300 patients. As an independent consultant, she provides expertise in areas such as project management, budgeting, and process improvement. Previously, she held director-level positions at Novartis and other large pharmaceutical companies where she led global process improvement initiatives reducing time and costs.
The document provides a summary of Dawn Marie Rady's skills and experience. It includes 3 paragraphs:
1) Her objective is to lead a large patient-centered service group and provide high quality care. She has skills in management, training, care management, and quality improvement.
2) She has a Bachelor's in Nursing and is licensed in Wisconsin. Her education includes a nursing degree from Marian College.
3) Her experience includes over 15 years in quality improvement and management roles for health insurance and hospital organizations, where she improved processes, oversight programs, and patient outcomes.
This document is a curriculum vitae that provides biographical information about Mohammad Jamil Ahmad Salim. It includes details about his education, certifications, goals, experiences, and courses attended. He has a Bachelor's degree in nursing from Jordan University of Science and Technology and a Master's degree in medical laboratory science from the same university. His experiences include working as a quality consultant, training manager, and nursing supervisor at various healthcare organizations in Jordan. He has numerous certifications in areas like emergency medical training, auditing, and healthcare accreditation.
Shafik Janhangeer is a British national with over 14 years of experience in construction safety management in Qatar and other countries. He has a Master's degree in environmental science and is a Chartered Member of the Institute of Occupational Safety and Health. Currently he is an HSE Supervisor on the massive Lusail City development project in Qatar, where he has successfully implemented safety programs and achieved a zero-incident record over 5 years. He seeks to leverage his expertise in developing and enforcing strong HSE policies and systems to reduce risks and ensure compliance.
This document is a resume for Bangaly Keita that highlights their experience and qualifications. Keita has over 10 years of experience in both project management and healthcare administration. They are currently a Senior Project Manager overseeing projects aimed at optimizing financial processes in healthcare organizations. Previous roles include Project Manager, Healthcare Administrator, and Registered Nurse. Keita has a background of successfully implementing improvements in efficiency, quality of care, and cost savings across several healthcare organizations.
This document provides guidance for developing clinical practice guidelines at the Royal Children's Hospital in Melbourne, Australia. It outlines a 17 step process for guideline development that involves identifying a topic, forming an authoring team, reviewing evidence, drafting content, obtaining stakeholder feedback, finalizing and approving the guideline, implementing it, and evaluating its impact. Key principles include developing guidelines through a multidisciplinary process, basing them on the best available research evidence, and involving consumers throughout. The overall goal is to improve healthcare quality and outcomes for patients.
Lorrie Manacchio has over 30 years of experience in manufacturing, operations management, training, and quality assurance. She is currently a Senior Manager of Operations and interim Packaging Manager at AstraZeneca, where she oversees packaging operations and ensures adherence to schedules, training, safety, and performance targets. Prior to this role, she held various management positions at Johnson & Johnson, Pfizer, GlaxoSmithKline, and other organizations, where she improved processes, reduced deviations, and developed her team members. She holds a Green Belt certification from Villanova University and degrees in Chemistry and Medical Technology.
Erin Diaz has over 20 years of experience in healthcare IT and clinical analysis, with a focus on Allscripts SCM implementations over the past 10 years. She currently works as a Clinical Analyst III at New York Presbyterian Hospital, where her responsibilities include successfully implementing EMR systems, compiling technical specifications, and serving as an IT representative on multiple committees. Prior to this role, she held several sales, marketing, and operations positions in the diagnostic imaging field, consistently exceeding goals and improving operations.
Jess Mc Govern has 3 years of experience in a GMP laboratory, including method development, validation, equipment qualification, data review, and training. They hold a BSc in Industrial Biochemistry and are proficient in analytical techniques like HPLC, GC, and UV/Vis. In their current role at Eurofins Lancaster Laboratories, they perform pharmaceutical analysis, write reports, and assist in management responsibilities. They are organized, a strong communicator, and enjoy artistic pursuits and traditional Irish music in their free time.
This document provides a summary of Chris Bolam's qualifications, experience, and skills in risk management and health and safety. It includes his contact information and 20 years of experience in these fields across various industries. Key achievements highlighted include implementing risk registers and assessments, leading risk management strategies and policies, and managing teams. Skills include audit, project management, cultural change, and training. Recent roles include Health and Safety Manager at Manchester Metropolitan University from 2011-2016.
TranScrip provides services across the pharmaceutical development lifecycle including translational medicine, clinical development, regulatory affairs, medical affairs, drug safety, and portfolio management. They help biotech and pharmaceutical clients address challenges and achieve their drug development and commercialization goals. Their teams integrate seamlessly with clients and provide expertise, oversight, and flexible support to maximize opportunities and reduce risks throughout the drug development process from early research through commercialization.
1. 1
CURRICULUM VITAE
Marie-Noëlle Debelle
e-mail: marie-noelle.m.debelle@gsk.com
1977-1983 CATHOLIC UNIVERSITY OF LOUVAIN (Louvain-La-Neuve)
• Sciences Department
Master in Biology (Zoology), January 83, distinction
Major in Ecology and Toxicology
Thesis topic : “Toxicotolérance de deux espèces d’Oribates Corticicoles au dioxyde
de soufre”
• Post-graduate diploma of “Agrégation” for High School Teaching” in June 83
1971-1977 MARTIN V LYCEE (Louvain-la-Neuve)
Classical Humanities - latin-sciences section
High school diploma in June 77
From Sept 14 GLAXOSMITHKLINE BIOLOGICALS
Senior Manager, Risk Management Lead
Quality and Risk Management Platform
Research & Development / Medical Governance
• Work closely with QRM area leads to ensure a robust framework for Risk
Management is in place across R&D
• Develop strong network with Vx Compliance to further embed and grow RM
in R&D and to ensure consistent implementation of agreed strategies
• Act as trainer for RM and coach through dedicated workshops
• Build risk facilitator capabilities through the R&D RF Community of Practices
• Propose tools and templates to leverage business ownership (e.g. Risk versus
Issue decision tree, R&D risk list, R&D risk map, criteria for good risk
description)
• Be SAP GRC expert and R&D RMPO for SAP granted access
• Perform quality checks on priority R&D risks with feedback to relevant risk
facilitators, monitor preparation and plan of priority R&D risks to R&D Risk
Management Board (RMB)
• Generate KPIs on priority risks with monitoring and visibility at RMB
• Manage a team of up to 3 managers and/or administrative assistant
Last update July 2015
30 years of experience in Pharmaceuticals
Education
Professional Experience
2. 2
From Augt 13 GLAXOSMITHKLINE BIOLOGICALS
Senior Manager, VVHS Risk Management Implementation Lead
Vaccine Value & Health Science / Medical Governance
• Lead the implementation of the enhanced risk management framework (RMF)
across VVHS
• Direct, coordinate and supervise the roll-out of RMF by ensuring prompt and
regular communications to relevant impacted people
• Build capabilities of the Quality & Risk Management (QRM) team in
identifying, preparing and/or reviewing risks according to new criteria and
coach them to obtain an efficient risk management process across VVHS
• Collaborate closely with the QRM team and the business to stimulate and
embed risk management within normal practice
• Work closely with RM process owner of VDD and ITx to obtain R&D Risk
Register and optimise the transversal view and effort in the way risks are
managed
From Apr 09 GLAXOSMITHKLINE BIOLOGICALS
Senior Manager, Quality and Risk Management, Global Regulatory Affairs
Vaccine Value & Health Science / Medical Governance
• Lead compliance excellence and quality improvement in the area of Global
Regulatory Affairs across GSK Biologicals VVHS network, including cross-
departmental processes
• Direct, coordinate, supervise and follow up the mutually agreed business risk
register and associated risk treatment plans
• Support the business in audits and inspections e.g. help in preparation,
coordination, hosting of event, guide and advise in wording responses until
completion of CAPAs
• Collaborate closely with the business to stimulate process improvement, do
right first time and strengthen quality excellence
• Lead and develop a collaborator and manage his activities
1987-2009 GLAXOSMITHKLINE PHARMACEUTICALS - BELGIUM
Feb 2001 Manager, Clinical Quality Assurance
Medical Affairs and Clinical Development department
• Ensure adherence to standards of quality and compliance with Good Clinical
Practice regulations/guidelines and GSK policies and procedures (SOPs)
• Identify CR training programs and calendar for new and existing CR staff - Co-
ordinate and/or conduct initial and ongoing GCP and cross-functional process
training
• Prepare, co-ordinate and/or facilitate audits and Regulatory Inspections – ensure
timely completion of CAPA plan - communicate audit findings, share
experience in their resolution and adapt training accordingly
• Establish, in partnership with the QA unit, internal audits and self-inspection
activities for the Medical Department, e.g. on SOP Management, Training
Records, Training Plans, Clinical Trial Supplies, labels translations, Safety and
Archiving
• Assume the Regional Hub Trainer role for Belgium and the Netherlands
• Promote sharing of best practices and expertise in SOPs, processes and systems
within the Medical Department and across the European Quality network
Last update July 2015
3. 3
• Roll-out audit learning’s and audit alerts within the department, stimulating
dialogue to understand how these issues can be addressed at working levels
• Act as active member of the Quality Efficiency Team in charge of the
implementation of QMS requirements within GSK Be organisation
• Participate in the generation of Business Continuity Plans, Pandemic Plans and
Risk Management Plans applying to the Medical Department
• Lead the SOP development and management process, ensuring their effective
roll out
• Supervise the overall Clinical Trial Supplies process to meet the requirements
of GCP, GMP and GDP, and ensure the correct handling of CTS by the CRO in
charge of the local depot
• Lead and develop collaborators and manage their activities
Feb 2000 Clinical Quality Support Manager
Medical Affairs and Clinical Development department
• Ensure and maintain the competitive position of GWB Medical Affairs and
Clinical Development within GSK R&D organisation by driving and enforcing
clinical compliance with regard to GCP, SOPs and regulations
• SOP Management (administration, development and implementation of SOPs)
• ‘Accredited local trainer’ (initial and on-going GCP/SOP training for new and
existing staff)
• Support and expertise in GCP, SOPs and regulations
• Centralised processes for training records, SOP management, Clinical Trial
Supplies, CT labels translations and Archiving
Sept 1997 Quality Assurance Officer
Medical Affairs department
• SOP Management
• Expertise and training of GCP and SOPs
• Coaching of CRAs and assistants, set-up of the co-monitoring process
• Centralised processes for training records, supplies and archiving
1994-1997 Medical Data Scientist and Quality Control
Medical Department
• Validation of clinical data for phase I-III clinical trials
• SOP Administrator
• Local Trainer
• Safety nominee (pharmacovigilance)
1992-1994 Medical Resources Scientist
Medical Department
• Development and delivery of specific training programmes for internal and
external delegates (CRAs, sales representatives, physicians, investigators)
1989-1992 Clinical Research Scientist
Medical Department
• Writing of protocols and creation of CRFs
• Initiation and monitoring of clinical trials
Last update July 2015
4. 4
• Local projects (marketing support) and international (registration purposes)
• Therapeutic areas: gastroenterology and antibiotics
• Training of sales reps for above therapeutics areas
1987-1989 Sales Representative (Informateur Scientifique)
Sales Department
• Public relation activities
• Promotion of pharmaceutical products
• Domains in gastroenterology, pneumology, dermatology and antibiotics
• General practitioners and specialists
1984-1987 GIST-BROCADES LABORATORIES
Sales Representative (Informateur Scientifique)
Sales Department
• Promotion of pharmaceutical products
• Domains in gastroenterology, cardio-vascular, dermatology, paediatrics and
allergology
• General practitioners and specialists
Training, SOPs, GCP and Regulatory Affairs
Sept 2010 Physician Foundation Programme – GSK Biologicals Faculty
May 2010 Guaranteeing Quality for Audit Success – Brussels - Harrison Clinical Research
Mar 2010 Vaccines Initiation Workshop - GSK Bio – Vaccines Academy
May 09- Oct 10 Regulatory Affairs Legislations – GSK Bio – Regulatory Policy group
Nov 2009 Drug Information Association – Paris - European Regulatory Affairs workshop
June 2007 ACRP: How to get prepared for EMEA Inspections and National Competent
Authority
Inspections
Sept 2007 Regulatory Compliance Workshop Group (RCWG): Solving the Problem in
Designing,
Implementing and Managing SOPs for CR
Oct 2006 ECCRT Congress - Brussels - on EU CT Directive and its implementation into B
Law
2005 Member of « Drug Information Association »
Nov 04 DIA congress on EU CT Directive - Paris
Practical implementation and lessons learned
94-08 International Business meetings (2x/year) covering GCP, SOPs and trainer
role
Last update July 2015
Training and complementary education
5. 5
1995 How to detect fraud and misconduct
Workshop - Rostrum - Antwerpen
1997 Challengers for improvement in the area of GCP, independent audits and
inspections - Congrès DIA - Brussels
2002 Solving the problems of managing SOPs in Pharmaceutical Research – Henri Stewart
Conference Studies – Washington DC
Leadership, Communication and sales
Apr-Sept 14 Job plus Coach Program: how to make more impact
June 2013 Practical Coaching in the workplace – 1 day – GSK Biologicals (HR)
Apr 2013 Energy for Performance (3days) – GSK Bilologicals (HR)
Nov 2005 Leading in a complex environment - UK - European Leadership Foundation
2004 Time Management training - Atlas Business Training, Anvers
Sept-Dec 03 Leadership Foundation and Principles - European Leadership Foundation
2003 GSK European Leadership Foundation - 2 workshops - Self as leader and leading
others
1998 Project Team Management
1996 Training skills accreditation process - 3 modules of 3 days
Excel Communication (UK)
1992 Les relations interpersonnelles dans la vente - Wilson Learning
1990 Public speaking
Face to face
1985-1986 Agir sur autrui (10 sessions) - Eric Krauthammer
Marketing
1989 Territory Management
Product Management
1992 Le Marketing pour non-initiés
Data Management
1994 Glaxo Optimally Linked Database training – internal training (UK) - 10 days
validation process for clinical data
Computer science
2006 Synaps - Brussels - Excel prise en mains
2004 Advanced course Powerpoint - Synaps
1997 Powerpoint 7.0 (Dialog)
Last update July 2015
6. 6
MS-Exchange NT 5.0 (Dialog)
Internet (Dialog)
1996 MS-Word 7.0 (Dialog)
MS-Excel 7.0 (Synaps)
1994 Windows (Synaps)
Access (Synaps)
Teaching and student job
1983 3 months interim as teacher at Don Bosco school - Brussels
1979-1981 Secretary office – reception desk at Universtity Halles in LLN
French - mother tongue
Dutch - good knowledge spoken and written
- training : Nederlandse Academie 90/91
Berlitz School 88/89
Cefora 02/03
English - very good knowledge spoken and written
- internal training (1995)
German - basic passive knowledge
ϕϕϕϕϕϕϕϕϕϕ
Last update July 2015
Languages
7. 6
MS-Exchange NT 5.0 (Dialog)
Internet (Dialog)
1996 MS-Word 7.0 (Dialog)
MS-Excel 7.0 (Synaps)
1994 Windows (Synaps)
Access (Synaps)
Teaching and student job
1983 3 months interim as teacher at Don Bosco school - Brussels
1979-1981 Secretary office – reception desk at Universtity Halles in LLN
French - mother tongue
Dutch - good knowledge spoken and written
- training : Nederlandse Academie 90/91
Berlitz School 88/89
Cefora 02/03
English - very good knowledge spoken and written
- internal training (1995)
German - basic passive knowledge
ϕϕϕϕϕϕϕϕϕϕ
Last update July 2015
Languages