Physician and and Pharmaceutical Expert: Pharmacovigilance With Focus on Drug Safety, Evaluation and International Regulations

Technical Consultant #1525

Central cholinergic mechanisms (nucleocortical and septohippocampal pathways) related to the learning process and short-term memory in normal and aged brains.
Experimental models and tests of acetylcholine as a neurotransmitter in learning and memory loss.
Screening of compounds (such as pyroglutamic acid, oxiracetam, aniracetam and pramiracetam) with the potential of use in humans for Alzheimer's disease and other age-associated memory impairments.
Expertise in European pharmaceutical research and development and common technical documents.
Managing and monitoring Phase 1 and 2 clinical trials.
Safety evaluation of drugs and API compounds in the field of cardiovascular, hypo- cholesterolemic, analgesic and antifungal drugs.
Qualified person for pharmacovigilance.
Drug registration through European regulatory authorities.
Writing of expert reports on selected pharmaceutical technical issues.
Skilled working with AIFA, Italian Medicines Agency and the European Medicine Agency (EMEA.)

Independent Consultant and Researcher, 1997 - Present

Provided clinical research services for pharmaceuticals, biotech products, medical devices and nutritional supplements.
Writing of expert reports both in the NTA and CTD clinical trials (Phase II and III) medical writing and drug registration through the European Regulatory Authorities covering the areas of:
- Cardiovascular Diseases
- Dermatology
- Gastroenterology
- Oncology
- Pain
- Pediatrics
- Plastic Surgery
- Rheumatology
- Venous Microcirculation

SmithKilne Beecham (SB) Group, Research and Development Director, 1984 - 1996

Safety evaluation and pharmacology of compounds in the field of cardiovascular (platelet aggregation inhibitory agents, hypocholesterolemic, analgesic and antifungal drugs.
The pharmacological or toxicological studies (acute toxicity, subacute and chronic toxicity, reproductive toxicology, mutagenesis, carcinogenesis, special toxicity) carried out in-house and with contracted research organizations (Huntington, Inveresk, RBM, etc) or international academic institutions.
Managed several clinical trials with antirheumatic and analgesic drugs in rheumatology and sportive traumatology, hypocholestolemic, antiobesity, platelet aggregation inhibitory, cognition enhancing, and antifungal drugs.

University of Messina, Pharmacology, Professor of Cellular Pharmacology, Italy, 1993 - 1995

Activity focussed on entral cholinergic mechanisms (nucleocortical and septohippocampal pathways) in the cognitive processes, such as learning and short-term memory, in normal and aged brains.
Experimental models of amnesia (f.i., amnesia induced by scopolamine, ECS and the N-methyl-D-aspartate receptor antagonist amino phosphonovalerate) were used to investigate the role of acetylcholine as a neurotransmitter in learning and memory.
Developed model to screen compounds with potential of use in humans for Alzheimer's disease and other age-associated memory impairments, such as pyroglutamic acid, oxiracetam, aniracetam and pramiracetam.
Studied the in vitro binding of nootropic drugs with several neurotransmitters receptors.

Publications