- good knowledge of european regulations, ich-gcp guidelines and Pharmacovigilance.
- clinical Project Management,
- Clinical Study Design and science)" >Protocol development
- scientific and Medical writing
- leading and managing scientific projects
- people Training and Coaching
- experience in Preclinical Research : Immunology, cancerology, vaccinology, Cell biology, molecular biology, Virology, Gene-cell therapy, Cell Culture, In Vivo models, cell-based Assays and Drug Discovery Informatics, Bioinformatics, Statistics
Freelance Scientific ConsultantBrussels
Since June 2011
Scientific writing and advising, medical and scientific information, biotech watch
r&d services company, belgium/morocco – jun. 2013- present (part-time)
- advice and information on european and moroccan legislation on bioequivalence studies
clineurodiag - brussels, belgium – 2011- dec, 2013 (part-time)
- Scientific writing
- scientific and strategic advice
- medical and scientific information
- scientific advice concerning the development and the Validation of ELISA Assays based on Biomarkers.
- participation in the conception and development of new tools, based on microarrays technology, to be used in molecular Diagnostic of viral and Infectious diseases.
Scientific writing and advising, Medical and scientific information, Biotech Watch
R&D Services Company, Belgium/Morocco – Jun. 2013- Present (Part-time)
- Advice and information on European and Moroccan legislation on Bioequivalence Studies
ClinEuroDiag - Brussels, Belgium – 2011- Dec, 2013 (Part-time)
- Scientific writing
- Scientific and strategic advice
- Medical and scientific information
- Scientific advice concerning the development and the validation of ELISA assays based on biomarkers.
- Participation in the conception and development of new tools, based on microArrays Technology, to be used in molecular diagnostic of viral and infectious diseases.
Research Scientist (B-Life mission in N'Zérékoré (Guinea)) Brussels, Belgique and N'Zérékoré, GuineaFebruary 2015 --- March 2015
- deployment of a mobile Laboratory: the Biological Laboratory light fieldable for emergencies (b-life), in support of the ebola Treatment centre (etc) run by the medical ngo alima in the outskirts of n’zerekore (guinea), to provide analytical services, based on molecular biology techniques, of blood samples needed to fight against ebola, allowing to discriminate between people actually infected and other.
- contribution to jiki Clinical Trial: diagnosis and follow up of ebola positive patients under favipiravir Treatment.
- Validation of new rapid Diagnostic tests
Regulatory Affairs Specialist Mont-GodinneJanuary 2013 --- April 2013
- preparation of documentations concerning Clinical trials on lymphoma immunotherapy
- compilation, submission and management of Clinical Trial Applications (ctas).
- clinical science)" rel="nofollow">Protocol development
- preparation and coordination of Informed Consent from (icf) and case report form (crf) according to the science)" rel="nofollow">Protocol, the international conference on harmonization – Good Clinical Practice (ich-gcp) and on the house Standard Operating Procedure (SOP)
- review and evaluation of protocols, technical and scientific data and reports required for submission
- ensure that documents comply with all regulatory aspects
- manage and follow-up of responses to questions from Health authorities and Ethics committees
- generation and maintenance of study essential documents
Research Scientist GentJanuary 2003 --- May 2011
- development of universal vaccine against influenza a Virus.
- study of the molecular mechanism of influenza vaccine
- role and implication of systemic and pulmonary immune effectors in vaccine-induced protection from influenza Virus infection
- development of In Vitro Diagnostic Assays.
Scientist ZellikJanuary 2001 --- December 2002
- researching the molecular mechanisms and biochemical links between multiple sclerosis and chronic fatigue syndrome, as well as the association with other chronic immune disease.
- development of In Vitro Diagnostic test.
- therapeutics development: structure- and property-based Drug Design, identification and optimization of drug-like compounds and setting up Cell-based assay for Molecule screening.
PhD student BrusselsJanuary 1995 --- January 2001
Interest in knowledgeCreative thinkingDependabilityKindnessCuriosityApproachability
SociabilityAssertivenessOptimismIndependenceCollaborationCritical thinkingEfficiencyOrganizationProblem solvingAttention to detailCuriosityInterest in knowledgeCreative thinkingReaction to stressSelf-disciplineAdaptabilityTrustWillingness to compromiseInnovative thinking
Project ManagementscienceTeamworkVirologyVaccinesImmunologyGeneticsCell biologyLife SciencesScientific methodologyClinical trialsCoachingPhases of clinical development (phase I to IV) Scientific writingClinical researchPrinciples and ethics of clinical researchProblem Solving
PCRPowerPointDeveloping Clinical Trial ProtocolsPre-clinical researchInformed Consent DocumentsQuantitative PCR (qPCR)Medical oncology R&DAllergy and immunologyRT-PCRDrug Safety and PharmacovigilanceSDS-PAGEWriting Study Procedures and SOPsSerious Adverse Event (SAE)Drug InteractionSOPDrug metabolismTechnical reportsRegulatory affairsVirologyMicrosoft OfficeWestern BlottingPreclinical regulations and practicesPharmacovigilanceAssay developmentCell CultureIn VitroProof of concept (POC)Enzyme-linked immunosorbent assay (ELISA)BiochemistryLaboratory testingInformed Consent ProcessPharmacokineticsPreclinical developmentActions and modes of action of drugs in the human species Animal modelsScientific methodologyMarketing Authorisation Application (MAA)New Drug Application (NDA)Drug regulatory authoritiesKnowledge of the drug development processUnderstanding of regulatory guidelinesVaccinesLifesciencesBiotechnologyMedical DevicesActions and modes of action of human physiologyPharmacodynamicsPrinciples and ethics of clinical researchoncologyBiopharmaceuticalsGene therapyIn vivo modelsPhases of clinical development (phase I to IV)Clinical trial designInfectious diseasesSearch literature on clinical trialsInterpret clinical trial resultsDrug development processPulmonary diseasesInflammationGood Clinical Practice (GCP)ICH GCP guidelinesEarly development stageRegulatory StrategiesCTAEMABiomarkersLife SciencesCell TherapyCell-based assays and drug discoveryICH-GCPRegulatory submissionsDiagnosticsMicrobiologyCancerImmunohistochemistry (IHC)Scientific WritingPulmonary InfectionsImmunologyProtocolMedical writingmolecular biologyMedical affairsGMOEthics submission and approval processCell biology R&DAnimal ModelsELISAEnglishFlow CytometryIn VivoLaboratoryMedical consultingMicrosoft ExcelMolecular & Cellular BiologyPCRPowerPointPre-clinical researchQuantitative PCR (qPCR)R&DRT-PCRSDS-PAGESerious Adverse Event (SAE)SOPTechnical reportsVirologyWestern BlottingAssay developmentProof of concept (POC)Laboratory testingPreclinical development Animal models
Skills and Expertise
Analytical skills Gene therapyassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.collaborate in research projects at universitiesCollaborate with project teamCommunicative skillsConduct university research Creates a collaborative team environmentGuide staffLiaise with research teamlifesciencePlan work to meet objectives and deadlinesPublication of articlesResearch at universitiesSolve problemsWork collaboratively with the other members of the clinical research team
Interact with pre-clinical scientistsprepare study-related documentation; Prepare sound articles for publicationPrepare required regulatory documentsEthics committee submissionsManuscript preparation and reviewCreates a collaborative team environment Molecular DiagnosticsBiomarker ResearchR&DWork with the PI to manage the day-to-day activities of the study including problem solving and protocol management.Work collaboratively with the other members of the clinical research team Understand and react to the internal politics and demands of the companyPrepare regulatory documentation packets Execute scientific projectsDesign studiesMolecular DiagnosticsFluorescence Activated Cell Sorting (FACS)Design preclinical experimentsIn vivo studiesRegulatory documentationattend Investigator meetings requiring travel and report pertinent information back to research team members.collaborate in research projects at universitiesConduct literature searches.Conduct research at universitiesCoordinate with the ethics committeeCreate Standard Operating Procedures for each study or clinical trial.Develop protocolsDesign the studyDevelop regulatory strategiesDirect co-workers to achieve resultApprove suitability of patient information and consent documentsPlan work to meet objectives and deadlinesPrepare medical reportswrite an understandable and appropriate subject consent form and information leafletWrite final medical reports based on the physician's evaluationWrite protocolsPublish scientific projectsAttend seminars, courses and meetings within and outside the companyAssemble regulatory applicationsDiscuss the results of testing with medical statisticiansGenerate regulatory submissions Writing regulatory documentsPrepare regulatory documentsEscalate compliance and study issues to Director, Study ManagementEvaluate, review and assess protocols and amendments for feasibility generate Clinical Trial Report and manuscript for publicationGenerate regulatory submissions through written reports, summaries or evaluationsInteract with physiciansInteract with regulatory agenciesInteract with statisticiansInterpret dataLiaise with professionals in other divisions of the company as requiredLiaise with research team in order to accurately collect and record dataPerform investigative site file reconciliation: requests any new and updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements.perform regulatory authority application and approvalsEnsure consistency between the protocol and CRFEnsure all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs execute and publish scientific projects (in biology)Teachingput together a succesful ethics committee applicationRead medical literature to maintain current awareness and knowledgeReport conclusions to stakeholders and other interested partiesReview the interpretation of dataSubmit regulatory applicationsSupport oral and written presentations of clinical results by study investigators.take responsibility for completing all study specific procedures according to the study protocol.take responsibility for reviewing inclusion and exclusion criteria for the PI.lifescience
Ph.D. in Biological Sciences from Université libre de Bruxelles in 2001
Licence Speciale in Molecular Biology and Biotechnology from Université libre de Bruxelles in 1994
Licence en Sciences (Bachelor of Sciences) in Animal Biology from Faculty of Sciences, Sidi Mohammad Ben Abdallah University in 1989
Training and Certification
Regulatory Affairs Training in 2013 Training
Stem Cell, Regenerative Medicine and Clinical Trials in 2013 Training
Clinical Study Expert (CLINET) in 2012 Certification
WIPO Certificate (General Course on Intellectual Property) in 2012 Certification
FELASA C Certificate (Federation of Laboratory Animal Science Associations) in 2006 Certification
Certificate in Enterprise Management in 2005 Certification
Expert has 12 publications (Will be avalible with full profile)