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Programa / Program ABSTRACTS / RESÚMENES LUNES 13 DE DICIEMBRE / MONDAY, DECEMBER 13 INAUGURAL PLENARY LECTURES / CONFERENCIAS PLENARIAS INAUGURALES PL-01 THE CONCURRENT CHALLENGES OF EFFECTIVENESS RESEARCH AND INDIVIDUALIZED THERAPEUTIC STRATEGIES Gianni Tognoni South Institute for Pharmacological Research, Santa María Imbaro, Chiety, Italy. email: [email protected] The proposal of focusing the attention on the two apparent extremes of care (on one side the public health relevance and transferability of the paradygm of EBM, on the other side one of the expected clinical yields of genomic-translational research) aims to underline and exemplify the strict complementarity of the two scenarios. Methodologically and operationally, both approaches do propose a very promising future for the development of pharmacological research, with closer links to the highly productive area of outcomes- oriented epidemiology and with the most advanced sector of basic sciences. It seems specifically important that the two areas could be developed in close interaction, possibly within the same department(s), to assure a productive interplay of competences in the collaboration with clinical care, as well as in the training of the new generations of pharmacologists, pharmacists, clinicians. PL-02 BASIC PERIPHERAL MOLECULAR COMPONENTS OF INFLAMMATORY PAIN H Ferreira School of Medicine of Ribeirão Preto. Department of Pharmacology, Campus USP, Ribeirão Preto, SP. Brazil. email: [email protected] When non steroidal anti-inflammatory drugs mechanism of action was discovered, I proposed that their analgesic effect resulted from the prevention of the nociceptor sensitization by prostaglandins. Thus, pain in an inflammatory process results from an action of mechanical, thermal or chemical stimuli upon sensitized nociceptors (hiperalgesia, hypernociception-HPr). A tissue noxious stimulus triggers an array of inflammatory HPr tissue events like the release of bradykinin and C5A complement factor and of a cascade of cytokines. This cascade is initiated by TNF-α and culminates with the release of IL-1 that activates tissue and neuronal cyclo-oxigenases with subsequent release of prostaglandins. Thus, the inhibition of any point of this cascade, causes analgesia by nociceptor sensitization prevention. The molecular mechanism of HPr involves the stimulation of cAMP pathway with subsequent a) activation TTX resistant sodium channel, lowering neuronal threshold and facilitating neuronal membrane conduction and b) an increase in cytosolic K+ and Ca++ causing a variation of the resting potential which also facilitates nociceptor activation c) activation of “ganglionar retrograde sensitization” which maintains HPr. There are drugs like dipyrone, diclofenac, keterolak, bremazocine, peripheral opiate analgesics that cause analgesia by opening K+ channels ATP sensitive, thus restoring normal resting potential. This effect is dependent of the activation of the arginine/NO/cGMP pathway. PL-03 CUBAN SCIENTIFIC DEVELOPMENT TODAY: IMPACT OF THE BIOTECHNOLOGY IN THE PHARMACOLOGICALS SCIENCES DEVELOPMENT Luis Herrera Martínez Director of the Center for Genetic Engineering and Biotechnology, La Habana, Cuba email: [email protected] Cuba is an example of the much a small country with very limited resources can do in the field of sciences. Cuban biotechnology has the special characteristic of being a forerunner, beginning at the precise moment this science was taking its first steps in the United States and the world. Other distinctive features of Cuban biotechnology are the implementation, from the beginning, of the concept that all workplaces involved had to complete the research, technological development, production and commercial cycle, integrating cooperation among them, and achieving results of great impact on the national health care system. Several of the Cuban biotech products are unique, such as the meningitis B vaccine, the Heberprot-P (innovative product indicated to treat diabetic foot ulcers), the PPG anti-cholesterol pill, vaccine against Haemophilus influenzae type b (the first worldwide synthetic vaccine), in addition to monoclonal antibodies and vaccines for the treatment of 77 VacciMonitor 2010, Vol. 19 Suppl. 2 cancer, together with agro-biotech products. Today, Cuban scientists are working in the development of new projects of therapeutic vaccines, some of which are in very advanced evaluation stages, for instance, therapeutic vaccines against Hepatitis B, Hepatitis C and prostate cancer. Health impact is evident at population level in many fields: Haemophilus influenzae type b epidemics have disappeared; hepatitis-B is about to disappear in the infant population. The Cuban population under 29 years of age is immunized against hepatitis B, whose incidence is the lowest in the world. In Cuba the available production capacities have been able to supply goods for Cuban needs and for export, achieving regulatory standards according to current Good Manufacturing Practices (GMP). For example, the facilities of the Centre for Genetic Engineering and Biotechnology and those of Biocen for the production of Hepatitis-B vaccine have been inspected and received certification of the World Health Organization (WHO), becoming a UN prequalified vaccine to be used by the UN purchasing agencies. The impact of the Cuban biopharmaceutical sector on improving health is undoubtedly larger because there is extensive cooperation between the research institutions and hospitals, when developing the biopharmaceutical products. Certainly, to our knowledge, no scientific, social and economic phenomenon of this nature has occurred in any other developing country. MARTES 14 DE DICIEMBRE / TUESDAY, DECEMBER 14. PLENARY LECTURES (PL) / CONFERENCIAS PLENARIAS PL-04 NEW LEGISLATION IMPROVING PHARMACOVIGILANCE IN EUROPE: NEWS ARISING FROM THE RECENT EUROPEAN LEGISLATIVE CHANGES Mariano Madurga Jefe del Área de coordinación del SEFV-H. División de Farmacoepidemiología y Farmacovigilancia. Agencia Española de Medicamentos y Productos Sanitarios. The new European legislation in pharmacovigilance aims to streamline and strengthen pharmacovigilance activities and will require joint action the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) and the Spanish Pharmacovigilance Regional Centers for commissioning, development and implementation. The following are the changes most relevant to the operation of European and Spanish regulation: 1. Individual notifications of suspected adverse reaction • The SEFV-H will record the suspected adverse reactions arising from any use of medication including, therefore, overdose, mis-administration / misuse, abuse of drugs and medication errors. Computer systems must be prepared for them and identify them once incorporated into the database. • Establish the necessary mechanisms to enable the direct notification of patients and users. In this sense, the more efficient approach would be a web portal to facilitate this notification to citizens who, in turn, must be integrated with database (as FEDRA) to redirect cases to the Regional Centre respective. It is estimated that this could be a 20% increase in the number of ADR reports received today. • It should be made publicly available database of suspected adverse reactions (as the Spanish FEDRA), with different levels of access depending on whether it is a health professional, a patient or pharmaceutical companies. • You must record and process notifications of suspected non-serious adverse reactions received from pharmaceutical companies (so far only sent the cases severe) in prescribed time periods. • It should promote electronic reporting, the health authorities must provide electronic access via websites, for the reporting of suspected ADRs by healthcare professionals and patients and users. 2. Moving to a more proactive pharmacovigilance It will need to manage clinical information sources and pharmacological (BIFAP, etc.) that enable epidemiological studies in the new framework of a proactive pharmacovigilance. 3. Enhance Transparency It should enhance transparency and disclosure. Programs also should be made to enhance communication of suspected adverse reactions to both health professionals and patients, even for different consumer groups. 4. Continuous monitoring of the Benefit / Risk The competent authority shall conduct a continuous monitoring of FEDRA database to identify potential security problems that can lead to changes in the benefit / risk of medicines. 5. Audit The Competent authorities on pharmacovigilance will be audited by the European Commission every two years to ensure compliance with these tasks and ensure the quality of the data. VacciMonitor 2010, Vol. 19 Suppl. 2 78 6. Pharmacovigilance Risk Assessment Committee (PRAC) Currently, the Pharmacovigilance Working Party is a working group of the Committee of Medicinal Products for Human Use (CHMP). New legislation will change it: an assessment committee composed of one member by each Member State, six members of relevant experts (incl. clinical pharmacology, pharmacoepidemiology), one member from healthcare professionals, and one member from patient associations. The mandate of the PRAC shall cover all aspects of the risk management of the use of medicinal products including detection, assessment, minimisation and communication related to the risk having due regard to the therapeutic effect of the medicinal product, the design and evaluation of post-authorisation safety studies and pharmacovigilance audit. PL-05 PHARMACOVIGILANCE
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