Quality Assurance Training

CURRICULUM VITAE

INGRID KOSTER, BSC, MSC

Phone: +55-21-360*-****

Mobile Phone : +55-21-810*-****

E-mail: *********@*****.***.**

BACKGROUND

**** – 1998 Master Degree – Public Health / Epidemiologist

Escola Nacional Saúde Pública – FIOCRUZ – Ministry of Health / Brazil

1993 Post Graduation – Public Health / Epidemiologist

Escola Nacional Saúde Pública – FIOCRUZ – Ministry of Health / Brazil

1986 - 1992 Biological Sciences

Medicine College, Rio de Janeiro, Brazil

Universidade Federal do Rio de Janeiro (UFRJ)

PROFESSIONAL EXPERIENCE

09/2006 to Project Leader

09/2009 Kendle International, Rio de Janeiro, Brazil

Activities:

Clinical & operational support for Phase I-IV trials. Responsible for protocols in therapeutic areas:

Dermatology (Severe Acne); Gastroenterology (Crohn`s Disease and Severe Diverticulitis);

Rheumatology (Arthritis Rheumatoid and Systemic Lupus Erythematosus); Neurology

(Multiple Sclerosis); Pneumology (Pulmonary Arterial Hypertension).

Direct collaboration for analysis and defense of clinical trials proposals with international team and

Study Sites (Feasibility): patient population; study design and assessments, potential sites, local

structure and legislations.

Contribution for activities regarding proposals and projects defense: study budget, FTEs, activities,

deliverables, deadlines, milestones, study team and current local requirements.

Local Pharmacovigilance organization supervision.

Professional development of trainees, clinical research assistants and project assistants.

Patient recruitment supervision and study monitoring activities (including AE/SAE notification)

according to international requirements (SOPs, GCP, FDA) and local legislation.

Resolution of issues regarding financial contracts and local fees for biological samples shipment

that contributed to achieve over recruitment for patients in Crohn`s Disease Protocol.

Pharmacovigilance Notifications and Reports; Regulatory submissions (IRB; MoH); Study Budget

and Clinical Supplies Management (Importation process; study drug distribution; retrieval and

destruction).

Set up, Coordination, Management and Execution of study related activities among implicated

areas, being primary contact between clients and sub-contracted companies and vendors among;

Experience with ARO being the primary contact for the organization of repots and results from

Steering Committees; Advisory Boards for Cardiology and Pathology areas.

Project Plan & Reports elaboration, including timelines, team communication, Study Data

Monitoring Plan, Lessons Learned, according with what was proposed for the Project development;

Ensure Project progress and development and, if necessary, elaboration and execution of corrective

actions or alternative tasks for eventual upcoming issues such as regulatory delays, backlog of

clinical data, budget and resources trough international or local support operation teams in order to

guarantee that the project still aligned to what had been proposed.

Continuous monitoring of project resources (team, study supplies and budget) by reports, tracking,

meetings in order to anticipate solution for the issues and the rationale use of the study resources.

Critical and continuous analysis of the projects to avoid or mitigate risks and anticipate change in

scope or resources implementations.

Preparation of study material, Newsletters, study results presentation, training or meetings with

clients and/or investigators.

New business and opportunities development and collaboration for the related activities, including

presentations to the clients and vendors.

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PROFESSIONAL EXPERIENCE (CONITNUATION)

11/2005 to Clinical Research Manager

09/2006 Schering-Plough Research Institute – SPRI / LAFE - Rio de Janeiro, Brazil

Activities:

Clinical and operational support for Phase I-IV trials, being responsible for protocols in therapeutic

areas: Cardiovascular (Acute Myocardial Infarction), Infectious Diseases (Anti-HIV and

Hepatitis), and Oncology (Acute Leukemia).

Study set up activities; Patient recruiting supervision and qualification inspection for multi-centre trial

(including AESAE report) under GCP, FDA and Brazilian regulations.

Regulatory submissions (IRB; MoH); Study set up activities; Study Budget and Clinical Supplies

Management (Importation process; study drug distribution; retrieval and destruction)

Local Clinical Operation structure supervision (Rio de Janeiro).

02/2002 to Latin America Clinical Research Assistant (Senior)

11/2005 Servier Laboratories

ICTR Latin America (International Center of Therapeutic Research) - Rio de Janeiro, Brazil

Activities:

Clinical and operational support for Phase I-IV trials, being responsible for protocols in therapeutic

areas: Cardiovascular (Angina Instable, Stroke, Acute Myocardial Infarction), Metabolism

(Diabetes) & Endocrinology (Hormonal Replace Therapy); Phsyquiatry (Depression).

Study set up activities; Patient recruiting supervision and qualification inspection for multi-centre trial

(including AESAE report) under GCP, FDA and Brazilian regulations.

Study set up activities; Study Budget and Regulatory submissions (IRB; MoH) and Clinical Supplies

Management (study drug distribution; retrieval and destruction)

Local Pharmacovigilance Local Collaborator (site and regulatory notification, report, files & tracking).

Clinical Study Supplies (distribution, retrieval and destruction).

08/1999 to Clinical Research Assistant (Senior)

11/2001 GlaxoSmithKline – GSK (ex GlaxoWellcome and ex SmithKline Beecham companies).

Clinical Research Department / Medical Directorate – Pharma Division / Rio de Janeiro, Brazil

Activities:

Clinical and operational support for Phase I-IV trials, being responsible for protocols in therapeutic

areas: Anti-Infectious (HIV), Cardiology (Hypertension), Endocrinology (HPB, Diabetes) and

Oncology.

Study Financial Costs management.

Pharmacovigilance Notifications and Reports;

Regulatory submissions (IRB; MoH); Study set up activities; Study Budget and Clinical Supplies

Management; Importation process; study drug distribution; retrieval and destruction)

MedTrack (Clinical Study Data system) lead user.

08/1999 to Head Professor of Clinical Pathology & Haematology Disciplines

07/2001 Universidade Severino Sombra – CECEN / Biological Sciences Course

Vassouras - Rio de Janeiro, Brazil

Activities:

Regular lessons, experimental laboratory practices and professional integration for trainees.

10/1991 to Clinical Research

12/1993 Ministry of Health – FIOCRUZ/ CICT/ DIS - Rio de Janeiro, Brazil

Activities:

Professional Improvement and Specialization Program.

Projects II & I: “Studies and Research in the Area of Information for Health and Environment”. Period: April

to September 1991

Project: “Inventory of Resources in AIDS Research in Latin America and Caribbean” – OPAS/WHO. Period:

November/1990 to March/1991.

Projects I : “Tendency of Health Investigation in Brazil”.

II : “Tendency of Health Scientific Production in Brazil”.

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PROFESSIONAL EXPERIENCE (CONITNUATION)

10/1989 to Trainee

10/1990 Financiadora de Estudos e Projetos – FINEP. Biological Science and Health Division - Rio de

Janeiro, Brazil

Activities:

Research and Development Projects Analysis for the development of Clinical Protocols proposals

and development requested by Universities and Hospitals in Pharmacological and Virology Areas.

PROFESSIONAL CERTIFICATIONS & LICENSURES

2008 People and Team management (short duration course in IBMEC)

2000 “Clinical Research Monitor” – Approval Certificate obtained from SBPPC (English abbreviated version for

Society title: Brazilian Society of Clinical Research Professional).

1998 Schoolmaster in Public Health / Epidemiologist

1993 Post-graduated in Public Health / Epidemiologist.

1992 Graduated in Biological Sciences.

PUBLICATIONS

“Reliability of Diabetes mellitus referred as a cause of death: comparative multiple causes mortality analysis using CID-9

and CID-10 in Niterói, RJ, Brazil, 1993 and 2000.”- Maya, L.G.; Koster, I.; Monteiro, G.T.R. and Koifman, S. Public

Health Master degree. Orientation: Prof. Dr. Sérgio Koifman. Rio de Janeiro, 2003.

“Diabetes mellitus: Mortality as Basic and Associated Causes in Niterói city (RJ) on 1993” – Final dissertation in

Epidemiology and Quantitative Methods Department - Escola Nacional de Saúde Pública/ Fundação Oswaldo Cruz.

Public Health Master Degree. Orientation: Prof. Dr. Sérgio Koifman. Rio de Janeiro, 1998.

PRESENTATIONS

“Clinical Research: Step by Step in a Pharmaceutical point of view” / I Fórum de Ensino e Pesquisa da Irmandade

da Santa Casa da Misericórdia de Santos” – 11 November 2008. Santos, São Paulo.

Pharmacovigilance: Spontaneous Notification - ICTR and Marketing Department training – Servier. Rio de

Janeiro, Brazil. July 2004.

CONTINUING EDUCATION, TRAINING, AND PROFESSIONAL MEETINGS

People and Team management. IBMEC – Rio de Janeiro, Brazil. May to September, 2008.

Trial Watch Training – Regulatory part. Kendle, Rio de Janeiro, Brazil, March, 2007.

Part 2 eClinical Training – Managing the investigational sites and documenting site visits contacts in eClinical.

Kendle, Durham, North Carolina, USA. 29 January to 01 February, 2007.

Project Leader: Management – 28 December 2006.

Monitor’s & Investigator’s Meeting (Galderma Study) – Cannes, France, 9 to 10 December, 2006) and San

Antonio, Texas, 8 to 13 November, 2006.

eClinical Navigation Training. Kendle, Rio de Janeiro, Brazil. November, 2006

Kendle Project Management – The Essentials. Tlalnepantla, Mexico city. 24 to 29 October, 2006.

Monitor’s & Investigator’s Meeting (Improve-it – Cardiology study). – Santiago, Chile. August, 2006.

Monitor’s & Investigator’s Meeting (Victor I and II – HIV study). – Miami, USA. Period: July, 2006.

Training Courses at Schering-Plough Research Institute: “Presentation of the factory”; “R & D Formation”;

“Internal SOPs”; “Quality Assurance”; Study Data Management – Internal Program”; e-CRF (InForm). –

Kenilworth, New Jersey, Period: 28 November to 16 December, 2005.

Marketing Products training: Procorolan ad Coronaries Disease. Servier- Neuilly, France. 18 to 21 January, 2005.

Monitor’s Meeting (Cardiology study). – I.R.I.S (Paris, France). Period: 25 and 26 January, 2005.

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CONTINUING EDUCATION, TRAINING, AND PROFESSIONAL MEETINGS (CONTINUATION)

Monitor’s Meeting (Cardiology study). – I.R.I.S (Paris, France). Period: 08 and 09 September, 2004.

e-CRF: InForm 4.0 – Training the Trainer. Phase Forward – Servier. Rio de Janeiro, Brazil. 01 to 03 October 2,

2009, 2003

Marketing Products training: Coversyl (Hypertension and CD) 25 and 26 June, 2002; Diamicron MR (Diabetes),

02 July, 2002; Daflon (Circulatory) 04 July, 2002; Vastarel (CD), 10 July, 2002. Servier Rio de Janeiro, Brazil.

SETHI training – ICTR Latin America. Rio de Janeiro, Brazil. Period: 27 and 28 May, 2002.

Monitor’s Meeting (PREDIM 2 - Diabetes study). – I.R.I.S (Paris, France). 10 April, 2002.

ICTR training (applied monitoring activities) – Servier, Warsaw (Poland). 18 to 26 March, 2002.

Training Courses at Institut de Recherches Internationales Servier (I.R.I.S.): “Presentation of the factory”; “R & D

Formation”; “Quality Assurance”; “Therapeutic Division of Metabolism stage”; “Pharmacovigilance”. Servier. Paris,

France. 18 March, 2002 to 10 May, 2002.

“Latin America Safety Meeting” – GlaxoSmithKline / Brazil - Global Product Safety & Pharmacovigilance (GPSP).

Rio de Janeiro, Brazil. 18 to 20 August 2001.

Electronic Data Capture: QDM Individual Training Session – electronic CRF management. International Medical

Education & Development (IMED). North Caroline / RTP, USA. 08 September, 2000.

Clinical Research Refresher – International Medical Education & Development (IMED). GlaxoWellcome / Rio de

Janeiro, Brazil. 03 August, 2000.

Enhanced Study Monitoring Course – International Medical Education & Development (IMED). GlaxoWellcome /

Rio de Janeiro, Brazil. 01 to 02 August, 2000.

EPICS – Monitor’s Meeting (GlaxoWellcome) - Kensington Hotel (London, UK) – May, 2000.

Site Evaluation and Study Termination Workshop – International Medical Education & Development (IMED).

GlaxoWellcome / Rio de Janeiro, Brazil. 05 April, 2000.

Source Document Verification & Drug Accountant Workshop – International Medical Education & Development

(IMED). GlaxoWellcome / Rio de Janeiro, Brazil. 06 April 2000.

Medtrack (Training course as Lead User) – International Medical Education & Development (IMED).

GlaxoWellcome / Rio de Janeiro, Brazil. 28 March, 2000.

Electronic Data Capture (EDC – eCRF): QDE Investigator Training. GlaxoWellcome/ Rio de Janeiro, Brazil. 13

November, 1999.

“Latin American Safety Training Meeting” – GlaxoWellcome S/A. International Product Safety &

Pharmacovigilance (IPSP). GlaxoWellcome / Rio de Janeiro, Brazil. 13 and 14 July, 1999.

“Seminário sobre Pesquisa Clínica”. GlaxoWellcome/ Rio de Janeiro, Brazil. 5 and 6 November, 1999.

“Principles of Clinical Research” – GlaxoWellcome / Rio de Janeiro, Brazil. 13 and 15 January, 1999.

“Statistical Analysis-SAS”. FIOCRUZ/ENSP/LABI. Rio de Janeiro, Brazil. 23 to 30 August, 1993.

“Epidemiological Studies- EpiInfo”. FIOCRUZ/NECT-CICT. Rio de Janeiro, Brazil. 10 to 26 November, 1992.

“Introduction to Personal Computer”. UFRJ/NCE. Rio de Janeiro, Brazil. January 1991.

“Introduction to PC – MS-DOS system”. UFRJ/NCE. Rio de Janeiro, Brazil. October 1991

Mastering English course, CCBEU – Rio de Janeiro, Brazil, 1981 – 1987.

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THERAPEUTIC EXPERIENCE

Cardiovascular

Phase III and IV

• Systemic Arterial Hypertension

Phase III

• Stable Angina

Dermatology

Phase III

• Alopecia

Phase III

• Acne

Endocrinology

Phase III

• Benign Prostate Hyperplasia (BPH)

Phase III

• Diabetes Type II

Phase III

• Hormonal replacement Therapy (HRT)

Gastroenterology

Phase II b

• Severe Crohn`s Disease (severe and acute)

Phase III

• Diverticulitis (severe)

Infectious Diseases

Phase III

• HIV and AIDS (naïve and with complications)

Phase III

• Hepatitis

Phase III

• Tuberculosis

Oncology

Phase III

• Leukaemia

Phase III

• Lung Cancer (Small Cells)

Neurology

Phase III

• Acute Ischemic Stroke

Phase III

• Multiple sclerosis (MS)

Pneumology

Phase III

• Pulmonary Arterial Hypertension (PAS)

Rheumatology

Phase III

• Arthritis Rheumatoid

• Systemic Lupus Erythematosus (SLE)

LANGUAGES

Portuguese: Native speaker

English: Advanced (Fluency in reading, writing and speaking).

Spanish: Intermediate (Good knowledge in reading, writing and speaking)

French: Basic (Good knowledge in reading, writing and speaking).

BIOGRAPHY

Ingrid Koster had performed activities for the Ministry of Health (FIOCRUZ/MoH) since 1991. She was certified by the

Clinical Research Society (SBPPC, São Paulo) as “Clinical Research Monitor” in 2000 and had performed 2 public

th st

concourses for Epidemiologist of MoH obtaining approvals in 4 and 1 positions respectively for State Health Board

(Instituto Estadual de Infectologia São Sebastião – IESS/RJ, August 2004) and State Health Board (Município de Paraty,

Rio de Janeiro. October, 2006). She is a volunteer to read for blind people in one dispensary located in Niteroi, Rio de

Janeiro. He is certified autonomous diver. She loves to stay with her family watching movies, reading books or travelling.

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