Working in study start-up units for several years and several clients.

Focused on Ethics Committee in Competent Authority submission

Currently working in the Regulatory Affairs department of Biotech companies, providing Regulatory expertise for EU countries (includes CTA submissions in all of EU countries)

Therapeutic areas include (DRUG STUDIES):

• Oncology (SCLC, NSCLC, Breast Cancer, Pleural Mesothelioma, Pancreatic Cancer, Prostate Cancer, Ovarian Cancer, Colorectal Cancer)
• Hematology (FL, CLL, MDS, ALL, AML, Richter's Syndrome)
• Cardiovascular (Familial Hypercholesterolemia,  Anticoagulation in stroke prevention)
• Neurovascular (Stroke)
• Allergy (Peanut allergy)
• Anti-infectives (Complicated Intra-Abdominal Infections, Tuberculosis)
• Central Nervous System (Parkinson's disease, Multiple Sclerosis)
• Endocrinology (Diabetes, GHD, Turner's Syndrome)
• Genitourinary and urology (Urine incontinence, uterine myomas, erectyle dysfunction)
• Surgery (Intra-abdominal infections, Hip replacement)
• Gastrointestinal (Ulcertative Colitis)
• Others: Pancreatitis, Ulcerative Colitis, Rare Diseases

Therapeutic areas include (MEDICAL DEVICES STUDIES):

• Traumatology (Synthetic bone graft)
• Cardiovascular (Aortic Valve replacement)
• Neurovascular (Mechanical thrombus removal)
• Interventional Cardiology (Renal Denervation)
• Pneuomology (In-Vitro Diagnostic Test)

Phase I to IV clinical trials

Medical Devices studies

Pediatric studies

Non-Interventional studies, Registries

Non-drug Interventional studies

Nutritional supplements

Experienced in eCRF (Medrio, InForm, Medidata Rave, eMerge, IBM eClinical Oracle, Timaeus, Clindex, CatchTrial, SMS, and others) and Electronic Data Management Systems