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Summary

during the last 17 year set- up and monitoring of more than 50 efficacy and mode of action trials for registration purposes was my main occupation. those studies were set up in broilers, layers, pigs, turkey, dairy cattle and calves, with Veterinary and feed additives. the products investigated covered a wide range namely probiotics, ecto- and endo- parasiticides, coccidiostats, antibiotics, organic acids and electrolytes. further a resistance study monitoring streptococcus faecium & streptococcus faecalis sensitivity in pigs and poultry was initiated in feed stability trials and carcass quality trials served an european registration. Market research studies for coccidiostats and antibiotics were completed. assessment of Veterinary registration files and an efficacy Expert opinion used in a registration dossier for efsa were made. further i was Expert for application on efficacy for feed additives. Expert Food Safety 5th and 6 th e.u. framework programme. project technical assistant for 5th e.u. framework programme.

Experiences

Current Experience

  • owner

    Sint-Gillis-Waas, België
    Since October 2014

    -advise a Veterinary phamaceutical company on 1) possible experts for the completion of a dossier 2) the market for pre and probiotics in poultry for fattening product positioning possibilities. 3) desinfectants

    -Expert opinion on a registration dossier for pigeons

    -advise for the set up of eu Efficacy trials for a probiotic in dogs: gestating and lactating bitches, pups, adult dogs. write up of protocols. 

    -consultation on the different legislation eu / us for the use and authorisation of micro-organisms in feed  

     

    -Advise a veterinary phamaceutical company on 1) possible experts for the completion of a dossier 2) The market for pre and probiotics in poultry for fattening product positioning possibilities. 3) desinfectants

    -Expert opinion on a registration dossier for pigeons

    -Advise for the set up of EU efficacy trials for a probiotic in dogs: gestating and lactating bitches, pups, adult dogs. write up of protocols. 

    -Consultation on the different legislation EU / US for the use and authorisation of micro-organisms in feed  

     

Past Experience

  • owner

    January 1998 --- September 2014

     

     1) completeness check of a Veterinary registration dossier based upon Publications. task: litterature search for efficacy data, compilation and evaluation of data.

    2) market investigation for the use of a probiotic in preventing necrotic enteritis in broilers together with limited field investigation (trial science)" rel="nofollow">Protocol)

    3) compilation of 2 dossiers for re-authorization of 2 vitamin preparations including identification, properties, assay, safety, post Marketing authorisation.

    4) incidence of diseases in poultry needing Veterinary Treatment: compilation of data, interpretation, Statistics and presentation.

    5) field trial investigation on two pigfarms comparing 2 Veterinary products in staphylococcus hyicus infections: search for suitable farms, write up of the farm specific science)" rel="nofollow">Protocol, trial monitoring and reporting.

    6) monitoring of 6 floorpen trials on the efficacy of an antibiotic in a challenged Respiratory disease in turkeys for fattening.

    7)efficacy evaluation of a probiotic in lactating dairy cows at 3 different locations within the eu: science)" rel="nofollow">Protocol development, search for suitable trial sites, (spain, italy and the netherlands) and monitoring. co-author of the reports

    8) eu re-authorisation of a coccidiostat in broilers: write up of the master science)" rel="nofollow">Protocol search for battery and floor pen trial sites, co-ordination  of the tasks inoculum, assay, necropsy, lesion scoring etc, monitoring the trial sites, co-author of the reports 

     

  • Regional Manager

    September 1985 --- March 1999
    regional Sales Manager for the benelux, france, germany, switzerland, austria, spain, austria, italy, portugal, greece, north and central africa and the middle-east for albac (zinc bacitracin). this was followed by the development of a worldwide technical service providing material for sales support through manyfold contacts with the feedindustry agricultural institutes. help was provided in registration by setting up Efficacy trials in pigs broilers, calves and layers

  • Regional technical manager

    January 1981 --- August 1985
    -help in the development of safe and effective therapeutics. by drawing, monitoring and following up, registration and Research directed trials throughout europe for individual Veterinary Applications such as anti-mastitis, partus induction, systemic antibiotics as well as mass medication through feed and water. - follow- up of possible claims - co-ordination of technical service activities throughout europe

  • Veterinary adviser

    March 1975 --- December 1980
    - set-up trial in broilers, calves, pigs and cattle with feed additives such as coccidiostats, growth promoters and medicated feed in the benelux - author and co-author of 20 floor pen trials in broilers, 5 field trials in pigs, 1 in calves and 4 in cattle (internal reports). - draft of 3 technical manuals : elancoban, tylan and romensin - technical service activities: Sales support, complaint handling, customer Presentations (feed industry)

Personality

BrightOwl Assessment :
DependabilityOrganizationDiligenceAuthenticityInterest in knowledgeCuriosityPerspectiveResiliencyOptimism
Self Assessment :
EfficiencyAdaptabilityOptimismCreative thinkingInterest in knowledgeIndependence

Knowledge

BrightOwl Assessment :
EnglishFrenchProject ManagementClinical trial designMonitoring Study ProgressUnderstand how results translate to practiceUnderstand levels of research evidencedutch
Self Assessment :
RespiratoryInfectious diseasesUnderstand levels of research evidenceEnglishPatient Screening and RecruitmentProject ManagementPhase IVPhase IIIClinical trial budgetingMonitoring Study ProgressICH GCP guidelinesEfficacy trialsDeveloping Clinical Trial ProtocolsClinical trial designRandomization and blindingUnderstand how results translate to practiceInterpret clinical trial resultsSearch literature on clinical trials
LinkedIn Assessment :
efficacy trials in animalsSales ManagementRegistrationVeterinaryAnimal HealthPoultryFood SafetyRegulatory affairsAgricultureR&DAnimal NutritionAnimalsDogsscienceSwineBiotechnologyVeterinary MedicinePharmaceutical IndustryToxicologymolecular biologyFEEDIngredientsPetsInfectious diseasesClient EducationFood IndustryVaccinesEfficacyVirologyAnimal WelfareAnimal WorkImmunologyPharmaceutical salesLaboratoryPlant BreedingCattleGood Laboratory Practice (GLP)Regulatory submissionsPharmacokineticsAgribusinessClinical researchLifesciencesDrug DevelopmentClinical DevelopmentMarket researchAnimal HusbandryAnimal BehaviorEpidemiologyPharmacovigilanceClinical trials

Skills and Expertise

BrightOwl Assessment :
Interpret datalifescienceCreates a collaborative team environmentExecute scientific projectscoordinating research projectsCoach staffDirect co-workersGuide staffLiaise with research teamSolve problemsCollaboration
Self Assessment :
Act as the main line of communication between the sponsor and the investigatorAdminister, maintain and co-ordinate the logistical aspects of clinical trialsArchive trial documentation and correspondence.Assemble regulatory applicationsAttend at steering committee meetingsAttend seminars, courses and meetings within and outside the companyCollect data as required by the protocol and complete case report forms and reviews for completeness.Conduct literature searches.Design the studyDiscuss the results of testing with medical statisticiansDevelop protocolsDirect co-workers to achieve resultEnsure all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPsgenerate Clinical Trial Report and manuscript for publicationmarketingSupervise and/or distribute trial supplies, including the trial drug

Education

  • Dr.Med.Vet & Lic Zootechnie in Veterinary Sciences/Veterinary Clinical Sciences, General from Universiteit Gent in 1981
  • Dr.med.vet in veterinary medicine from Universiteit Gent in 1973

Training and Certification

  • expert EFSA in 2012 Certification
  • expert FAVV in 2006 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Professional Proficiency
French
Professional Proficiency
German
Professional Proficiency

Work Preferences

  • Notice Period:
    4 weeks
  • Work From Home:
    Yes, 1 to 3 days per week
  • Work Regime:
    BrightOwl freelancer :    32 Hours per week
  • International:
    Yes

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

De Klinge

Others

Driving License
  • Yes

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