S.Amara
Profile Last Update: 2021-10-08 18:04:32
Auditor Profile
S.Amara
Country
Belgium
Education
Highest Educational Qualification
Doctorate/PhD
Doctorate/PhD
Language(s)
FrenchProfessional
EnglishProfessional
ArabicNative
DutchIntermediate
Regulatory Framework
EU Regulation | |
US Regulation | |
Japanese Regulation | |
Rest of the World |
Auditing Experience
2 Years
Availability Time
Not Available for Hire
Number of Audits performed in the Last 3 Years
As Lead AuditorUp to 15
As Co-AuditorUp to 15
Number of Audits per Category performed in the Last 3 Years
Investigator Sites | 2 | 18.18% |
Sponsor System or Process Audits | 2 | 18.18% |
Clinical Laboratory Audits (Central/Safety) | 2 | 18.18% |
Clinical Laboratory Audits (Biomarker, PK/PD) | 1 | 9.09% |
Investigational Medicinal Product Audit (GMP for IMP) | 0 | 0% |
Electronic Systems Provider Audit (e.g. eCRF Provider, IVRS/IWRS Provider) | 2 | 18.18% |
Vendor/CRO (Full or Part service) | 2 | 18.18% |
For Cause Audits | 0 | 0% |
Pharmaceutical Product: Chemical | Current Practice |
Pharmaceutical Product: Biological | Current Practice |
Adv. Therapy Medicinal Products | Previous History |
Medical Devices | Not Applicable |
Consumer Products | Not Applicable |
Cosmetic Products | Not Applicable |
Food Stuffs | Not Applicable |
Industrial Chemicals | Not Applicable |
Investigator Site Audits | Previous History |
Sponsor System or Process Audits | Previous History |
Clinical Laboratory Audits (Central/Safety) | Previous History |
Clinical Laboratory Audit (Biomarker, PK/PD) | Not Applicable |
Investigational Medicinal Product Audit (GMP for IMP) | Subject Matter Expert |
Electronic Systems Provider Audit (eCRF, IVRS/IWRS,...) | Subject Matter Expert |
Vendor/CRO (Full or Part Services) | Previous History |
Due Diligence/For Cause Audit | Not Applicable |