For Contact point use only

Guidelines

Please fill in all sections of the Nomination Form as required: • Mandatory fields for Experts are indicated with • After completion click , type in the To: field the e-mail address of your Contact Point • Click to keep a record of this form

City:

Title: 1. Last Name:

2. First Name:

5. Business Tel: 6. Business Fax:

7. Business E-mail:

3. National of: 8. Qualifications - Degrees, Diplomas and Professional Affiliations [i]:

9. Present position and time in current assignment [ii]:

Nomination Form for European ExpertsThis form requires Adobe Acrobat Reader version 7.0

10. General Category of Activities

Medicines EvaluationBiologicals/Biotechnology

products:Chemicals:

Herbal/Traditional Products:Inspections:Pharmacovigilance:Regulatory Affairs:

Yes

Yes

Yes

Are you a member of staff of the competent authority?

Are you an external expert (e.g. University, hospital, member of staff of another Organisation, etc)? [v]

H [iii]

V [iv]

Male Female Gender:

4. Professional Address

Address:

Postal code:

Country:

Organisation Name:

11. Specific Functional Expertise [vi]

Quality

Biotechnology products:

Vaccines:Immunologicals/Biologicals:

Blood products:Chemicals:

Immunologicals/Biologicals:

H [vii]

V [viii]

Safety

Chemicals:Environmental Risk Assessment

Genetically Modified Organisms:

Immunologicals/Biologicals:Clinical

Chemicals:Pharmacovigilance and Risk Management

Laboratory Procedures:Inspections

GMP:GCP:GLP:

12. Availability

Dossier EvaluationScientific Advice

Other Specify:

13. Languages knowledge

Please specify level,R W S

R: Read, W: Write, S: Spoken, P: Poor, A: Average, G: Good, E: Excellent

Name of Head of Competent Authority:

Signature of Head of Competent Authority:

Competent Authority in Member State:

Date:

Please use for signature purposes the Nomination Form that will be generated by the Experts database at the end of the Request creation process. Sign below only when the Database is not available.

Are you a member of a Patient Organisation / Interest group / Charity?

15. Detailed Areas of Expertise (Please select main areas only)

15.a QualityChemicals: Biotechnology products: Risk Assessment of

GMOs:

Manufacturing Process, Development and Validations:

Analytical chemistrySynthetic chemistryDevelopment pharmaceuticsStabilityPhytochemistryRadiopharmaceuticalsPremixes for medicated feed productionDrug/Device combinationsPackagingManufacture of medicinesPeptide chemistryMedicinal gassesStructural similarity

Development geneticsGenetic engineering: expression factorCell culture - FermentationProtein purification

Protein analysis - characterisation; purity testing; biological assay

Virology: validation of inactivation/removal steps; cell blank qualification; choice of virusesMicrobiological testingMonoclonal antibodiesBlood productsAllergensVaccinesGene therapyCell therapyTissue engineeringPlant biotechnologyNanobiotechnology

VaccinesGene therapy/ biotechnologyTransgenic plant

Blood products

Biological productsBiotechnology productsVaccinesCell therapy

15.b Pre-ClinicalToxicology

General toxicology:Acute/chronic toxicity, etc

Special toxicology:In vitro toxicology

ImmunotoxicityReproduction toxicity

Genetic toxicityCarcinogenicity

ToxicokineticsPharmacology in laboratory and target animalsPharmacodynamicsPharmacokineticsPathology

Environmental Risk AssessmentResidue safety assessmentBehavioural toxicologyOccupational toxicologyMicrobiology:

BacteriologyParasitology

MycologyVirology

Safety Pharmacology

15.c Clinical (Please select 2-3 areas only)

AIDS

Genetics:Pharmacogenetics

Clinical Genetics GeriatricsGynaecology/obstetricsHaematologyHepatologyImmunology:

BiologicalClinical

Infectious diseases:MicrobiologyBacteriology Parasitology

Mycology Virology

AnaesthesiologyBiostatisticsCardiologyDermatologyEndocrinologyGastroenterology

Intensive careInternal medicineMetabolic medicineNephrology

Oncology:Blood

Breast

Gastro-intestinalGynaecological

Head & NeckLung

Renal

CNS

Other (please specify):

OphthalmologyOrgan transplantationOrthopaedic SurgeryOtorhinolaryngologyOther (e.g. reare disease), please specify:

General pathologyChemical pathology

Haematology

PainPaediatricsPharmaceutical MedicinePharmacologyPharmacokineticsPathology:

Histopathology

Plastic SurgeryPneumology / RespiratoryProctologyPsychiatryPublic HealthRadiologyRheumatologyStomatologyUrologyVaccines:

MicrobiologyParasitology

Mycology Virology

NeurologyNuclear medicine

15.d Target Species15.e Pharmacovigilance and Risk

Management

Food producing animals:HorsesCattle

PigsPoultry

FishBees

Rabbits

Goats & sheep

(Other) minor speciesPet animalsWild (zoo) animals

Spontaneous reporting systems and databasesPhase IV and PMS SurveillancePhase I-III Safety SurveillancePharmacoepidemiologyEpidemiology

Drug utilisationStatisticsTerminology & codingRisk CommunicationSafety of Viral VectorsAtypical Infections/ZoonosesVaccine SafetyRisk Management

15.f Control/Inspections GMP/GLP/GCP

Chemical

Laboratory procedures:

BiologicalBiotechnologyImmunologicals VaccinesImmunologicals - OthersRadiopharmaceuticalsOther (please specify):

Active SubstancesOther Starting MaterialsFinished ProductMarket SurveillanceOfficial Batch

GMP:

Active SubstancesOther Starting MaterialsFinished ProductControl LaboratoriesDistributorsOther (please specify):

GLP:

Quality Systems/AssuranceDocumentationJoint Visits/Self AuditingOther (please specify):

GCP:

Quality Systems (sponsor)Trial SiteStatisticsComputer SystemsDocumentationOther (please specify):

15.g Patient / Consumer Representation

AdvocacyCommunicationPolicy issuesConsumersPatients *

Medicines' Safety

Other (please specify):

Social Sciences

* If you have patients experience in a specific therapeutic area, please indicate in section 15.c Clinical

i Please give a brief description of your qualification (e.g. MD, Phd and your specialisation). A Curriculum Vitae (CV) must be attached. Do not refer to your CV in this box. Your main areas of expertise are to be addressed in section 15. ii Please give a brief description of your current job position and indicate the year that you started your current assignment. iii Human domain iv Veterinary domain v If you are an external expert, please continue to section 11 and tick the appropriate box(es), and subsequently indicate your detailed expertise by ticking the appropriate box(es) in section 15. vi Please note that you should indicate your detailed area(s) of expertise in section 15 by ticking the appropriate box(es). vii Human domain viii Veterinary domain ix This form is used to send the expert details to the contact point. After the contact point imports the details in the Experts database, he will be issued a nomination form that has to be signed by the Head of the Competent Authority (National Competent Authority or the EMA)