Karen PINACHYAN, MD

Past

Director of Projects at Murigenetics
Interne 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)
Medical School

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Connections

106 connections

Industry

Pharmaceuticals

Karen PINACHYAN, MD’s Summary

Medical Project Leadership for Health Care Industries
experience in :
Clinical Medicine
Drug Development
Project Management
Orphan Drugs
Interactions with Stakeholders
Medical Communication
Medical Information

Karen PINACHYAN, MD’s Specialties:

Clinical Medicine; DIU CESAM (medical statistics); DIU FIEC (clinical trials); Healthcare Management; Medical Devices;
Animal Experiments

Karen PINACHYAN, MD’s Experience

Director of Projects

Murigenetics

(Privately Held; Pharmaceuticals industry)

May 2009 — November 2009 (7 months)

- management of the follow-up process for an orphan designation with EMEA and FDA
- management of a scientific advice request from AFSSAPS, EMEA
- elaboration of the orphan drug development project
Interne

European Medicines Agency (EMEA)

(Government Agency; Government Administration industry)

October 2008 — March 2009 (6 months)

- created and managed a database of stakeholders, participated in management of interactions with key interested parties (including patients and consumers organizations, healthcare professionals organisations, learned societies etc)
- managed external queries from patients and healthcare professionals
- participated in meetings of several Scientific Committees and Working Parties, including the Committee of Human Medicinal Products (CHMP), but also PDCO, COMP, CAT, CVMP, HMPC, as well as Working Parties (Efficacy, Safety, Pharmacovigilance etc)
- acquired an extensive knowledge of the European pharmaceutical legislation, Community procedures, rules and mechanisms of EMEA’s internal functioning
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
- 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 provision to general public and healthcare professionals (mainly to physicians, including hospital emergency services, pharmacists and occupational and public health specialists) about intoxication by natural toxins, drugs, chemical products, cosmetics etc
- medical information provision about drug adverse effects
- reception and initial treatment of ICSR (mainly from general public), liaising pharmacovigilance team, management of safety alerts for drugs and food
- work with toxicology and adverse effects database (input, output, statistics), bibliographic research
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 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 Management , 2006 — 2007

curriculum : strategy, finance, marketing, human resources in healthcare Industry, economic diagnostics & expectations, negotiation, commercial management, market & panel studies, project management, international healthcare systems, international regulatory issues, quality management, audit, international distribution and logistics of healthcare products, innovation in healthcare industry, business development and corporate strategy, intellectual property, biotechnology management
Graduation thesis: "Rare Diseases and Orphan Drugs: uncovered need, incentive measures and strategy of development for biotechnology start-up"
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) , Training 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
- 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
Medical School

M.D. , human medicine , 1994 — 2000

graduated with honors

Activities and Societies:

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

Additional Information

Karen PINACHYAN, MD’s Interests:

Healthcare Industry, Medical Information, Pharmaceutical Industry, Medical Devices, Biotechnology, Orphan Drugs, Clinical Research

Karen PINACHYAN, MD’s Groups:

Drug Information Association - BioPharmaceutical professionals
Project Management Link - www.pmlink.org
Good Clinical Practice
Medical Device Link
Pharmaceutical and Healthcare Professionals Worldwide Network - www.PharmaWorldNet.com
Biotech & Pharma Professionals Network
Professionals in Pharmaceutical Industry and Biotech Industry
Continuing Medical Education
DrugStudy Network
EUROMED Marseille Alumni Group
The Life Science Executive Exchange
Clinical Development and Operations Info. Exchange
Russian connection
Medical Device Development, Marketing And Sales
Clinical Research Professionals
Biotechnology/Pharmaceuticals
Life Science Professionals
Medical Affairs Network
Medical Device Recruiting
Clinical Trial Performance Spot
Medical Device Opportunity
Pharma France
Pharmacovigilance & Drug Safety Network
Clinical Research Careers (Global)
Clinical Recruitment UK (Daily Updates!)
Medical Affairs Physicians
Clinical Research & Pharmaceutical jobs UK - Europe
Pharmaceutical Jobs in Switzerland
Life Sciences Opportunities in EU
Life Sciences Professional Network
Clinical
PMI Pharmaceutical Specific Interest Group (SIG)
Yerevan State Medical University Alumni
Medical Information Services & Communication
European Medicines Agency
Medical Information Professionals
MEDICAL SCIENCE LIAISON and MEDICAL AFFAIRS networkers
The French Clinical professionals group
Global Clinical Research Opportunities (GCRO) - Direct Employers ONLY
SEC's Pharmaceutical Discussion
Sharing Ideas about Pharmacovigilance
Pharma, Medical Devices & Life Science Network UK
SEC Recruitment- Regulatory Affairs and Quality Assurance Forum
DIU CESAM & DIU FIEC alumni
French-Speaking Networkers - Medical Affairs