Karen PINACHYAN, MD

Past

In-Service Trainee at European Medicines Agency (EMEA)
Director of Operations at Murigenetics
Resident Physician at Regional Anti-Poison & Pharmacovigilance Center, Marseille, France

Resident Physician at Assistance Publique - Hopitaux de Marseille

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Education

Ecole de Management de Marseille
Université Denis Diderot (Paris VII)
Université de la Méditerranée (Aix-Marseille II)

Université de la Méditerranée (Aix-Marseille II)
Université de la Méditerranée (Aix-Marseille II)
Université de la Méditerranée (Aix-Marseille II)
Université du Droit et de la Santé (Lille II)
Université de la Méditerranée (Aix-Marseille II)
Yerevan State Medical University

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Connections

60 connections

Industry

Pharmaceuticals

Websites

Karen PINACHYAN, MD’s Experience

In-Service Trainee

European Medicines Agency (EMEA)

(Government Agency; Government Administration industry)

October 2008 — March 2009 (6 months)

- participation in Agency's interactions with its stakeholders, mainly healthcare professionals and patients organisations, learned societies, industry organisations
- contribution to the Stakeholders’ Database (conception, design, information search and day-to-day management)
- drafting answers for external queries from the Agency's Stakeholders (mainly from patients, consumers, healthcare professionals, pharmaceutical industry and consulting services), according to the EMEA and EU policies in the field of the "Acces to Information"
- assisting Stakeholders in the interpretation of the EMEA information publicly available
- proactive diffusion of the information released by EMEA for public consultation by it’s stakeholders
- participation in meetings of all Scientific Committees of the Agency, including the CHMP, PDCO, COMP, CAT, CVMP, HMPC, as well as Working Parties (Efficacy, Safety, etc)
- developing an extensive knowledge of the European pharmaceutical legislation, Community procedures and rules and mechanisms of Agency’s internal functioning
- developing an extensive experience of working in multicultural/multilingual environment (EMEA staff is extremely international coming from all EU & EEA countries)
Director of Operations

Murigenetics

(Privately Held; Pharmaceuticals industry)

March 2007 — October 2008 (1 year 8 months)

- General management, multi-disciplinary project management
- Public relations with Stakeholders (including patients’ associations, healthcare professionals, academia, university hospitals, research organisms, bioclusters, associations etc),
- Representation of the company in all events with key Stakeholders (congresses, boards, public events)
- Communication management
- Management of an orphan medicinal product designation request from EMEA (medical writing of the application, managing application process with EMEA COMP, results - orphan designation No EU/3/08/531 successfully obtained), composition of the dossier for orphan designation for FDA (application process actually ongoing)
- Day-to-day management of the team, commercial negotiations
Resident Physician

Regional Anti-Poison & Pharmacovigilance Center, Marseille, France

(Hospital & Health Care industry)

May 2006 — April 2007 (1 year)

- medical information providing to general public and healthcare professionals (mainly to doctors, including hospital emergency services, pharmacists and occupational and public health specialists) about intoxication by natural toxins, drugs, chemical products, cosmetics etc
- medical information providing about drug adverse effects
- reception, assessment and initial treatment of ICSR (mainly from general public), transmission to the pharmacovigilance team
- working with toxicology and adverse effects database (input, output, statistics)
- management of safety alerts
- bibliographic research, information search, performance of queries and statistics
Resident Physician

Assistance Publique - Hopitaux de Marseille

(Hospital & Health Care industry)

September 2001 — November 2005 (4 years 3 months)

- participation in clinical medical, surgical and outpatient activity
- organisation of clinical staff meetings, grand rounds
- scientific medical writing activity (research papers, books chapters)
- training and courses for medical students
- organisation of and participation in scientific events, workshops and congresses in collaboration with stakeholders
- management of information & communication projects via internet and multimedia supports

Karen PINACHYAN, MD’s Education

Ecole de Management de Marseille

Master in Healthcare Company Management , Healthcare Company Management , 2006 — 2007

curriculum :
- strategy, finance, marketing, human resources in healthcare Industry
- economic diagnostics & expectations
- international healthcare systems, international regulatory issues
- negotiation, commercial management, market & panel studies
- international quality management, audit
- international distribution and logistics of healthcare products
- Project Management in healthcare
- biotechnology management
- innovation in healthcare industry, business development and corporate strategy, intellectual property
Université Denis Diderot (Paris VII)

University Diploma , Medical Devices and Biologicals , 2006 — 2007

curriculum:
- Regulation and norms for Medical Devices and Biologicals
- Certification procedures, CE marking, preclinical and clinical evaluation
- Clinical trials of medical devices, evaluation and quality management, vigilance and risk management
- Assessment of risk/benefit ratio, reimbursement issues
Université de la Méditerranée (Aix-Marseille II)

Postgraduate training , Postgraduate medical training in Public Health , 2006 — 2007

Medical Toxicology
Pharmacovigilance
Practical Training: Center of Toxicology and Pharmacovigilance of Marseille
Thesis:
"Rares Diseases and Orphan Drugs: uncovered need, incentive measures and strategy of development for biotechnology start-up"
Université de la Méditerranée (Aix-Marseille II)

DIU FIEC (University Diploma) , Formation of Investigator in Clinical Trials , 2005 — 2006

Curriculum:
- methodology, regulation and ethics of clinical trials
- post-authorisation follow-up, pharmacovigilance
- application in different areas of clinical pharmacology
internship : University Centre of Clinical Pharmacology and Therapeutic Evaluation, Marseille (Prof. Olivier BLIN)
- participation in realisation of clinical trials of phases 1-3
- participation in a phase 1 clinical trial as a healthy volunteer
Université de la Méditerranée (Aix-Marseille II)

DIU CESAM (University Diploma) , Statistics applied to clinical trials , 2005 — 2006

Modules METHO, SPEC & STARC
curriculum:
- drug development: from pre-clinical trials to phase 4
- medical statistics
- methodological principals of comparative clinical trials
- measurements, quality of life, study protocol
- pharmacovigilance
- Good Clinical Practice
- analysis of a clinical trial, biases, meta-analysis
- marketing authorisation dossier in France and European Union
Université de la Méditerranée (Aix-Marseille II)

University Diploma on Animal Experiments , Animal Experiments , 2005 — 2006

Diploma giving right to perform experiments on animals in France (special ministerial authorisation)
curriculum:
Good Laboratory Practice in animal experiments:
- Anatomy, physiology and pathology of laboratory animals
- Animal model, use of animals in pharmacological and toxicological studies, anesthesia,
- Ethical issues, optimisation of animal numbers, alternative methods
Université du Droit et de la Santé (Lille II)

University Diploma , Multimedia and Pedagogy in Healthcare , 2004 — 2005

curriculum:
- multimedia and medical pedagogy, information management
- evaluation tools and methods
- distant communication and learning tools and platforms, Rich media
- methodology and structurisation of training
- legal issues and copyright law
graduation work:
- creation of web-site http://www.orl-marseille.com (actually more than 100.000 visitors/year), leading information source in pediatric otolaryngology in french language in the world
Université de la Méditerranée (Aix-Marseille II)

Postgraduate training , Postgraduate medical training in Otolaryngology and Head & Neck Surgery , 2001 — 2005

Medical Resident programme in Otolaryngology, Head and Neck Surgery, Paediatric Otolaryngology, Audiology and Phoniatrics
Yerevan State Medical University

M.D. , human medicine , 1994 — 2000

graduated "summa cum laude"
Mkhitar Heratsi scholar

Activities and Societies:

Member of the Scientific Counsil of Medical Faculty
Member of the Administrative Council of the University
President of the Students' Association of the Medical Faculty
Editor-in-Chief of "Medicus", University's student newspaper