Health and Youth Care Inspectorate (Netherlands) (inter)national GCP inspections

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1 Curriculum vitae PERSONAL INFORMATION Helene Blok WORK EXPERIENCE July 2015 Present Senior Inspector Health and Youth Care Inspectorate (Netherlands) (inter)national GCP inspections May 2010 July 2015 Advisor Health Care Inspectorate (Netherlands) - Methodological advice in, contribution to and analysis of derived data from risk-based supervision, thematic supervision and research otherwise - Writing of and contribution to regulatory reports arising from risk-based and thematic supervision - Project secretary risk-based supervision on a specific theme/healthcare sector - (Co-) development of indicators for the purposes of risk-based supervision of specific themes/healthcare sectors - Inter process communication with scientific societies, objects under supervision, health care inspectors, and secretaries - Development and publication of the elementary set of risk indicators for the purposes of risk-based supervision on specific themes/healthcare sectors and, interconnected, co-development of web based surveys - Development of instruments for the purpose of supervision visits - (Co)development of dashboards for the purposes of supervision on objects under supervision on specific themes/healthcare sectors December 2008 May 2010 Advisor Dutch Institute for Healthcare Improvement CBO (Netherlands) - Scientific assessment of literature for purposes of evidence based multiand monodisciplinary guideline development - Counselling and progress control regarding the process on guideline development - Participation in National Action program on Selfmanangement (LAZ), development generic model, disease specific working groups, comorbidity - Participating in WHO Meeting of guideline development group on Self Care of Noncommunicable Diseases - Patient participation in guidelines - Participation as a trainer in the EBRO course (evidence based guideline development) Nursing coordinator outpatient clinic Pulmonary Diseases 13/2/18 European Union, Page 1 / 6

2 - Planning and coordinating tasks - Controlling progress and quality and safety of care - Govern personnel management, organisational and financial matters - Proposals regarding to and taking care of conduct of policy, operational policy and realisation of products/services of the outpatient clinic pulmonary diseases Nursing coordinator Pulmonary Hypertension - Advisory expert for patients as well as nurses - Co-ordination of diagnostics, treatment and care - Inform, counsel and carry out of medical technical proceedings ( nursing consulting hours) for patients with Pulmonary Hypertension - Conferences with pulmonary physicians, social workers, physiotherapists, dieticians, pharmacy, inpatient clinic - (Co)development protocols, guidelines and total care for patients with Pulmonary Hypertension - Participating in national working group PH-nurses - Intermediary between care in the first and second line - Education of nurses Nursing coordinator Cystic Fibrosis - Advisory expert for patients (parents) as well as nurses - Co-ordination of diagnostics, treatment and care - Inform, counsel and carry out of medical technical proceedings ( nursing consulting hours) for patients with Cystic Fibrosis - Conferences with pulmonary physicians, social workers, physiotherapists, dieticians, pharmacy, inpatient clinic, regarding the CFteam for adults as well as the CF-team of the Erasmus MC-Sophia (children s hospital). - Participating in the national study group CF-nurses and the study group Cystic Fibrosis of CBO (Dutch Institute for Healthcare Improvement) for development of the renewed national guideline Cystic Fibrosis - (Co)development protocols, guidelines and total care for patients with Cystic Fibrosis - Intermediary between care in the first and second line 13/2/18 European Union, Page 2 / 6

3 - Education of nurses Research coordinator Pulmonary Diseases - Prepare, advise, estimate and coordinate the conduct of fase I, II and III trials (sponsor- as well as investigator initiated), considering ICH-GCP, and drawing up of the necessary contracts - Assessment of feasibility of study protocols, contributing on possibilities regarding adjustments - Database control, data management, (financial) administration and archiving of the study materials - Communication with sponsors, in- and outpatient clinic, pharmacy, various laboratories, other departments, IRB, management department, financial department, legal department, pulmonary physicians, researchers and patients - Recruitment of participants - Registration and randomization of included patients - Administer visits regarding trials - Development of documents/guidelines regarding the conduct of trials and collecting data Research nurse Haematology - Prepare the conduct of fase I, II and III trials considering ICH-GCP - Database control, data management - Communication with sponsors, in- and outpatient clinic, pharmacy, various laboratories, other departments, IRB, haematologists and patients - Registration and randomization of included patients - Development of documents regarding the conduct of trials and collecting data Specialist nurse Oncology de Vierstroom, Gouda (Netherlands) - Advisory expert for patients as well as nurses - Co development project transmural care delivery - Education of nurses internal as well as external (Integral Cancer centre West) - Set up of a discussion group for people with cancer or after having had cancer Specialist nurse Oncology Groene Hart Ziekenhuis, Gouda (Netherlands) - Advisory expert for patients as well as nurses 13/2/18 European Union, Page 3 / 6

4 - Inform and counselling of patients with cancer - Conferences with oncologists, pharmacy, inpatients clinic - Development outpatient clinic for patients with (suspected) breast cancer, including nursing consultation hours - Participating in study groups e.g. the study group oncology nurses of the Integral Cancer centre West - Co development project transmural care delivery - Development of a guideline regarding preparation and administration of cytostatic drugs and total oncological care - Education of nurses internal as well as external (Integral Cancer centre West) - Set up of a discussion group for people with cancer or after having had cancer Nurse Groene Hart Ziekenhuis, Gouda (Netherlands) Department of Internal and Pulmonary diseases Nurse St. Jozefziekenhuis and Bleulandziekenhuis, Gouda (Netherlands) Various departments Nurse St Elisabethziekenhuis, Leiderdorp (Netherlands) Department of Obstetrics EDUCATION AND TRAINING 2017 BE Inspectors Basic Training Course European Medicines Agency (United Kingdom) Online BE Inspectors Basic Training Course 2015 GCP Inspectors basis Training Course European Medicines Agency (United Kingdom) Online EU GCP Inspectors basis Training Course 2014 Postgraduate training Supplementary training Directed Acyclic Graphs (DAG): A structural approach to bias 2010 Postgraduate training - Supplementary training Building and validating prediction models using logistic regression - Supplementary training Sample size calculation and power analysis for intervention and diagnostic 13/2/18 European Union, Page 4 / 6

5 research 2009 Postgraduate training Facultative module Qualitative Research 2007 Training course European Society of Cardiology, Nice (France) Course Pulmonary Hypertension: Clinical Experiences and Scientific Evidences Clinical epidemiologist Academic Master Evidence Based Practice 2004 Training course European Respiratory Society, Vienna (Austria) School course Cystic Fibrosis Research nurse Transfergroep Rotterdam (Netherlands) Research nursing Certificate in management Hogeschool Midden Nederland, Leusden (Netherlands) Management 1990 Oncology nurse Integraal Kankercentrum West, Leiden (Netherlands) Course oncological nursing Training course St. Antonius Ziekenhuis, Nieuwegein (Netherlands) Lung specialisation Nurse Ziekenhuis de Lichtenberg, Amersfoort (Netherlands) Initial education nursing Secondary education Chr. Lyceum, Alphen a/d Rijn (Netherlands) H.A.V.O ADDITIONAL INFORMATION 13/2/18 European Union, Page 5 / 6

6 Expertise Publications Ditewig JB, Blok H, Havers J, van Veenendaal H. Effectiveness of self-management interventions on mortality, all-cause hospital readmissions, chronic heart failure hospitalization rate and quality of life in patients with chronic heart failure; a systematic review. Patient Educ Couns 78 (2010) Van Spreuwel P, Blok H, Langelaar M, Kullberg, BJ, Mouton J, Natsch S. Identifying targets for quality improvement in hospital antibiotic prescribing. Neth J Med May;73(4): Projects Projects as mentioned under working experience Memberships Other Relevant Information 13/2/18 European Union, Page 6 / 6

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