4^th International Conference and Exhibition on Pharmacovigilance & Clinical Trials August 10-12, 2015 London, UK

2015 PhD at the Faculty of Biology, University of BucharestrnPresentation2014 :rn1.Fungal infectionprevalencein humans and animals, methodsof diagnosis and treatmentofhydro-alcoholextractofplants. International Symposium of Academy sciences of Moldova.rn2.Methods for restorimg wooden monuments altered under the action of fungus. rn3.Treatment of wood objects using compouds from plant extracts with antifungal effect.International Symposium of Drobeta.rnPublications of Nature Sciencesjournal Drobeta,2015:rn1.Bioresonance- a method for infectious furnace volume location.rn2. The enzymatic activity of fungi. The mycoparasitic effect of the Trichoderma strains has ecological implications since. rn3. Natural colors painter wood.rnrn

Despite the development of the pharmaceutical industry, currently at least 30 000 people die every year in Europe due to infections caused by antibiotic-resistant microorganisms: Entercoccus spp. vancomycin-resistant (VRE), Enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae) resistant to cephalosporins, third generation Enterobacteriaceae (K. pneumoniae) carbapenems-resistant and non-enteric (Pseudomonas aeruginosa) resistant to carbapenems. For now almost every existing antibiotic, bacteria have developed a resistance factor that protects them from the action. For each resistance factor, pharmaceutical companies have developed a stronger antibiotic - until today. In the battle between bacteria and antibiotics begin to tilt the balance of victory by these microorganisms. In these circumstances, return to traditional medicine seems to be the solution. In order to determine the antibacterial activity of the compounds of Syzygium aromaticum buds extract against bacteria isolated from nosocomial infections MDR, we used the disc-diffusion method and inoculation of 96-well plate BHI. Screening of genes coding β- lactam antibiotics resistance was performed by PCR. The active compounds of the ethanol extracts and essential oil of S. aromaticum were determined by HPTLC, respectively by GC. Gram positive and Gram negative strains isolated from nosocomial infections showed genotypic resistance characteristics lactam antibiotics. Hydroalcoholic extracts and essential oil of S. aromaticum were active against all MDR bacteria. Eugenol is the main component of the extract of E. caryophyllata. In conclusion, the extracts of S. aromaticum can successfully replace antibiotics whose action against MDR bacteria proved to be ineffective.

Javeria Fazal will complete her Master’s Program in coming July (2015) at the age of 28 years from University of Calabria,Italy.She has successfully completed Pharm D (Doctor of Pharmacy) from Pakistan.After it she was entitled as a Quality Control Assistant leading to Quality Control Manager in Pharmaceutical firm and also performed duties of Hospital Pharmacist in hospital.In 2013 she came to Italy with great ambition of Clinical findings so this is her first research throughout her academic career and she wants to proceed it to her PhD Program. rnrn

The aim of the study was to investigate if the average Pakistanis and average Italian kidney post transplanted patients have same episodes of adverse events after intake of cyclosporine, tacrolimus and corticosteroids and also to green light the safest as well as hazardous drug among these three and to explain the appropriate reasons for effectiveness and ineffectiveness of the respective drug. The subjects were randomly selected including 706 Pakistani and 568 Italian patients both male and female with inclusion criteria of teen age and geriatric patients as well to estimate the clinical response. Blood sample was taken from each subject in order to determine the amount of creatinine, glucose, hemoglobin and cholesterol which are ultimate parameters for cardiovascular and cerebrovascular accidents..Urine sample was also taken in order to determine level of protein. Also DFG (Delayed Graft Function) was observed in these subjects. Thirty one percent of Italian men and 26% of Italian women (out of 568 Italian patients) suffered from hypercreatininemia and hyperproteinuria including hemoglobinemia and hypercholesterolemia and only a minority of sample population was subjected to hyperglycemia whereas 22% of Pakistani men experienced from same adverse effect but for Pakistani women the percentage was 21.50 (out of 706 Pakistani patients). The sample was selected from different age groups but it was observed that majority of adverse effects were found between age group 46-55 and the percentage of occurrence of adverse effects was found to be least between age group 17-25. It was observed that for immuno-compromised patients DGF, mortality rate and risk of transplant failure has been shown minimum for corticosteroids, intermediate for tacrolimus and maximum for cyclosporine and for immuno-competent patients, tacrolimus was effective drug. Abnormal kidney function gives favourable place for growth of many bacteria and ultimately level of protein become raise and there will start competitive binding between these proteins and cyclosporine as cyclosporine itself is composed of 11-amino acids so those having same ‘R’ functionality with the attaching side of cyclosporine will compete and finally cyclosporine will not be available to bind with its receptor and will give rise to series of adverse events. Also it was observed that patient’s adherence was maximum with corticosteroids as they produce synergistic effect with adrenal glands steroid production thereby suppressing immune system with diminished adverse effects and was gradually decreasing as we move from tacrolimus to cyclosporine. These data suggest that immuno-suppressant drugs should be monitored with special care depending upon the immune status of the patient.

Julia Laín-Abril is a PharmD student graduated in CEU San Pablo University in Spain, currently finishing her MSc in Drug Discovery and Pharma Management at the School of Pharmacy from University College London; she is also trained in Clinical Trials Management and Regulatory Compliance at University of Chicago. She has participated in the X National Undergraduate Congress in Health Sciences in Spain to present her work on “Current status of the ethical codes in the Official Schools of Pharmacists of Spain”. Today she works as a Product Stewardship and Regulatory Affairs Scientist in London

Counterfeit drugs are a worldwide issue and its impact on public health is very well documented, being responsible for not only resistance to medicines but also patient deaths. Regulatory authorities are responsible for ensuring patients’ safety through the establishment of regulations that protect the four basic bioethical principles (autonomy, beneficence, non-maleficence and justice) and fighting against the counterfeit market. It is a fact that Internet has increased the breaches in the supply chains of highly regulated markets through online pharmacies that may be illicit or poorly regulated. The WHO states that medicines obtained from illegal Internet sites that obscure their physical address are counterfeit in more than 50% of cases. After studying the measures taken by regulatory authorities to ensure the safety of medicines and carefully analysing the current bioethical situation of the online market, it has been observed that Internet does not have an ethical code and most anti-counterfeit actions taken are focused on increasing the awareness of the consumer, reassuring the principle of autonomy. However, there are no actions detected to protect the principles of beneficence, non-maleficence and justice. It is suggested that further online anti-counterfeit measures focus on avoiding the reach of counterfeits to the online market instead of solely warning the consumers to prevent the purchase. For this, it will be necessary the collaboration of different parties -police, customs, government, pharmaceutical companies, regulatory authorities and healthcare professionals and patients- as well as a stronger will to promote an ethical online behaviour.

Ciuca Alina Maria is a student at the Faculty of Medicine Carol Davila Bucharest. In 2014 she participated in numerous national conferences and 3 international symposia.

Antibiotics are the only \"weapon\" against bacterial infections. However, with the advent of penicillin in 1941, bacteria have developed new resistance mechanisms, increasing with the advent of new classes of antibiotce. Due to the development of new mechanisms of membrane resistance by efflux of antibiotics and remarkable tendency to alter resistance gene expression by β-lactamase enzyme producing extended spectrum (ESBLs), carbapenemases, aminoglycosides blockers, Gram-negative is a global threat. Since the usefulness of antibiotics appears to be insufficient, finding ways antibacterial therapy is becoming increasingly important. Thus medicinal plants whose utility is known for thousands of years, can bring many benefits to the alternative therapy of infections in particular from immunocompromised patients hospitalized. The plants in this study were selected according to their action against parasites and bacteria. After drying under latest generation technology, we obtained hydroalcoholic extracts in ratio 1/2/5. Bactericidal compounds were identified and separated by HPLC.Gram negative strains from patients hospitalized, were identified by Vitek2 Compact. We used of arbitrarily primer PCR to evaluate the genetic relatedness of ESBL-producing strains. The results obtained invitro separate action extracts of J.nigra, E.cariphillataandA.absinthe and synergistic with different antibiotics on a gar medium seeded with isolates from immuno compromised patients hospitalized with null response to antibiotic treatment classic, we can supplyprospects in the discovery of new classes of antibiotics without side effects.

Princy Louis Palatty completed Post-graduation in Goa Medical College. He did PhD in Bioethics, Colombo University in 2014. Presently he is a Professor of Pharmacology at Father Muller Medical College, Visiting Professor of Bioethics at SRM Medical College, Chennai, Head of South India Unit, UNESCO Chair Bioethics at Father Muller Medical College Mangalore. He is an academician, researcher, bioethicist has over 50 research papers and reviewed 1 textbook and 22 textbook chapters.

In the collected data of ADR reporting among ‘in’ and ‘out’ patient, in the Pediatric department, the statistics showed low frequency of ADR reporting; (23) spontaneous and (79) tracked ADR reporting. This tertiary care centre caters to a wide variety of regions and heterogeneous composition ethnicity and genealogy. The attitude of patient and pediatrician have a tendency for claiming Dermatological Reactions, as ADR which were the commonest among spontaneous reporting, while tracked reporting showed an equal preponderance of gastrointestinal and central nervous system based reactions. ADR reflected the drug necessary to treat the prevailing illness of the population. The debatable issue of focused leading questions to elicit ADR over period of time complements ADR reporting. Various factors can modify the trend of ADR reporting. Constant surveillance of ADR would indicate vantage points for interventions and optimize therapy.

Virginia is a PhD candidate at the University of South Carolina in Clinical Pharmacy and Outcomes Sciences. She joined SONAR last year and contributed to several of their publications over the past year.\r\nCharles L. Bennett, M.D., Ph.D., M.P.P., is a hematologist and oncologist whose research focuses on preventing adverse drug events and improving drug safety. An international expert in his field, Bennett was recruited in Spring 2010 as the new endowed chair of the South Carolina Center for Economic Excellence (CoEE) in Medication Safety and Efficacy. Since then, he established SONAR to continue his work in drug safety.\r\n

Natalizumab is an effective immunosuppressive therapy for multiple sclerosis that received its initial FDA approval in 2004. Its most notable toxicity is progressive multifocal leukoencephalopathy (PML), an opportunistic infection that is the focus of an FDA mandated Registry (the Tysabri Outreach Commitment to Health (TOUCH) Outcomes Registry. The Southern Network on Adverse Reactions identified a fatal case of Natalizumab associated urethral melanoma and undertook an extensive evaluation of all cases of Natalizumab-associated melanoma included in the FDA’s Adverse Event Reporting System (FAERS) (between 2005 and 2014). Characteristics of these patients and report quality were analyzed. Report quality was based on a 15 point scale of various components. The mean patient age at the time of diagnosis of melanoma was 46 (s.d. 11). Seventeen patients were diagnosed with cutaneous melanoma developing in non-sun-exposed areas. We found that cases reported through the TOUCH registry were of lower quality (mean score 7.7) compared to others that reported outside of the USA (mean score 8.5, p<.008). Our findings suggest that in the United States, the TOUCH Registry should be expanded to require clinicians to report details of Natalizumab-associated melanoma, an opportunistic illness that frequently develops in immunocompromised persons. Also, the FDA-approved product label for Natalizumab should be revised to include information on occurrences of melanoma among Natalizumab-treated MS patients, particularly those who have cutaneous nevi prior to Natalizumab initiation. Natalizumab-treated MS patients and their physicians should be vigilant for changes in nevi appearances and development of new cutaneous lesions (particularly in non-sun-exposed cutaneous areas).