Structured Product Labels (SPLs), the package inserts that accompany drugs governed by the Food and Drugs Administration (FDA), hold information about Adverse Drug Reactions (ADRs) that exists associated with drugs post-market. This information is valuable for actors working in the field of pharmacovigilance aiming to improve the safety of drugs. One such actor is Uppsala Monitoring Centre (UMC), a non-profit conducting pharmacovigilance research. In order to access the valuable information of the package inserts, UMC have constructed an SPL mining pipeline in order to mine SPLs for ADRs. This project aims to investigate new approaches to the solution to the Scan problem, the part of the pipeline responsible for extracting mentions of ADRs. The Scan problem is solved by approaching the problem as a Named Entity Recognition task, a subtask of Natural Language Processing. By using the transformer-based deep learning model BERT, with domain-specific pre-training, an F1-score of 0.8220 was achieved. Furthermore, the chosen model was used in an iteration of Active Learning in order to efficiently extend the available data pool with the most informative examples. Active Learning improved the F1-score to 0.8337. However, the Active Learning was benchmarked against a data set extended with random examples, showing similar improved scores, therefore this application of Active Learning could not be determined to be effective in this project.

La tesi ha per oggetto l’autotutela amministrativa, specialmente quella c.d. decisoria “spontanea”, ovvero quell’insieme di poteri che consentono all’amministrazione di riesaminare i propri provvedimenti e di rimuoverli a vario titolo.
Di questi poteri si è indagato il fondamento dogmatico e positivo. La questione del fondamento è stata per lunghi anni affrontata dalla dottrina e dalla giurisprudenza in termini totalmente pre-critici e non problematici: l’esistenza di questi poteri era semplicemente scontata e le riflessioni sulla loro base giuridica si esaurivano perlopiù nella constatazione della loro necessità nell’immemore consenso circa la loro ammissibilità. Negli ultimi anni, invece, una parte degli Autori ha disconosciuto la natura implicita e per così dire “originaria” di questi poteri e ne ha perciò patrocinato la stretta riconduzione al principio di legalità: in altre parole, l’annullamento e la revoca non sarebbero affatto conseguenza della c.d. inesauribilità del potere amministrativo – negata da questa dottrina – e sarebbero perciò oggi ammissibili unicamente nei casi e nei modi disciplinati dalle due norme introdotte nella legge sul procedimento nel 2005. Ciò a garanzia della certezza dei rapporti giuridici e del legittimo affidamento dei destinatari dei provvedimenti ampliativi. Secondo un filone ricostruttivo in pare contrastante con il primo, altri Autori hanno inteso valorizzare gli elementi de iure condito a favore della obbligatorietà dell’avvio del procedimento di riesame, auspicandone contemporaneamente la generalizzazione, nell’ottica di una più complessiva trasformazione dell’annullamento d’ufficio in un nuovo istituto ibrido, rispondente alla funzione di alternative dispute risolution system o, se si vuole, di ricorso gerarchico. Per le stesse ragioni, l’istituto dovrebbe perdere il carattere ampiamente discrezionale, in favore di una vincolatezza totale o parziale. Questo secondo “fronte di attacco” alla ricostruzione tradizionale intende offrire soluzione al venir meno del sistema dei controlli di legalità sull’azione amministrativa. Lo studio ha sottoposto a verifica entrambi i filoni evolutivi richiamati, discostandosi dal secondo e, pur accogliendo parte delle argomentazioni ad esso sottostanti, anche dal primo. Quanto alla teoria dell’esauribilità del potere amministrativo, oggetto della prima linea evolutiva, si è ritenuto di condividere le considerazioni circa la tutela dell’affidamento degli interessati e della stabilità dei rapporti giuridici. È parsa tuttavia meglio rispondente alle categorie generali e alle esigenze del sistema (anche sulla base di una visione del diritto amministrativo quale “diritto dei terzi”, per natura volto alla tutela dell’interesse generale e non solo dell’interesse privato particolare coinvolto dall’esercizio del potere) la conservazione della tradizionale inesauribilità del potere, seppur assai mitigata, nella pratica, con riferimento all’esercizio dei poteri di ritiro degli atti favorevoli ai privati il cui affidamento sia concretamente meritevole di tutela. La natura discrezionale dell’annullamento d’ufficio (e della revoca), sottoposta a critica dalla seconda linea evolutiva, viene difesa sia sul piano del diritto positivo e pretorio (attraverso la riconduzione dei principali casi di annullamento c.d. doveroso al modello generale), sia sul piano delle categorie generali, a partire dalla natura dei poteri coinvolti e dall’analisi delle posizioni giuridiche dei soggetti interessati dai procedimenti di secondo grado. / The thesis focuses on the Italian system of so called autoprotection or selfprotection. This expression refers to the powers of public administration to revoke its own acts when deemed necessary to repair a vice of legitimacy or a vice of opportunity, without being bind to resort to the courts. Given the aim of this powers – the same of first grade powers plus a semi-judicial one – they are usually meant by judges and scholars as “widely discretionary”. Furthermore, it has always been believed that the choice to activate the correspondent proceeding is totally free for public administration; consequently, a demand of interested parties does not make binding the start of the procedure, opposite to what happens with administrative appeal proceedings. In recent years ECJ, ECHR and national case law has emboldened the limits to selfredress, making clear that legitimate expectations and the public interest to legal certainty must be taken into consideration and given sufficient protection. Lately, also the Legislator followed, making the annulment and the revocation harder to be put in effect when the first act is favorable to the addressed subject. In such cases, the revocation cannot be ordered for a mere reconsideration of already known circumstances (ius poenitendi) but only if new ones show up. At the same time, ex officio annulment is precluded after 18 months from the issuing of the first act, instead of the previous general limit of a “reasonable time”. On the other hand, the case law has apparently pointed out some hypothesis of mandatory annulment, such as for “anticomunitarian acts” and cost-producing acts. Based on these two orientation, some scholars suggested a global rethinking of the self-protection, its bases and its rules. The study analyzes the case law and the latest legislative reforms, proving that no mandatory annulment exists in the Italian legal system. Therefore, nor the ECJ principle of equivalence nor other principles require that selfredress become generally obliged. The thesis also aims to prove that selfprotection remains a discretionary power, in order to ensure that the contrasting needs (the rule of law on the one hand, and the legal certainty and legitimate expectation on the other hand) can be properly balanced in every decision, according to the Constitutional provision of article 97, which requires that both impartiality and good administration are pursued.

隨著知識經濟的發展，專利成為企業的重要資產，專利訴訟更成為企業經營管理必修顯學。專利之高度技術內容及其商業化本質，使得專利訴訟成為技巧最複雜、成本最高昂、耗費時間也最冗長的救濟程序，終而引發各界對於專利訴訟制度之反思，開始強調應循公平、合理、迅速、經濟、專業之糾紛解決程序來排解專利糾紛。美國於1982年制訂專利法第294條開放專利有效性及專利侵權爭議得由當事人自願提付仲裁，聯合國國際貿易委員會於1985年制訂國際商務仲裁模範法（UNCITRAL Model Law on International Commercial Arbitration），作為各會員國仲裁法制之參考藍本，世界智慧財產權組織（World Intellectual Property Organization，WIPO）亦於1994年成立「仲裁與調解中心」為智慧財產案件提供專業性及跨國性之糾紛解決服務。上開仲裁立法及機構設置均顯示專利仲裁制度之發展與成長。 專利是一種權利保護期間短暫、權利範圍不明確、保護客體高度技術化，且集結科技、法律、管理三大專業於一身之權利，其糾紛解決對於迅速性、專業性、經濟性、秘密性、靈活性、和諧性、跨國性及風險控制性之需求，正係仲裁程序所能提供之優點。惟專利權與仲裁程序仍有本質上之互斥，包括：專利權之獨佔性及其背後蘊含之龐大商機，吸引專利權人寧願循訴訟途徑奮戰到底；專利糾紛當事人之實力差距，使得雙方難以達成仲裁協議；專利糾紛對於調查證據之強烈需求，與仲裁程序強調之迅速、經濟致生衝突；專利判決的不確定性，以致專利案件約有50％的上訴成功率，此亦促使當事人欲循訴訟程序爭取由上訴審法官重新審視案件，而不願意循仲裁程序「一戰定江山」。 經本文就我國企業專利糾紛循仲裁程序解決進行分析，發現有下列幾點之限制：一、我國企業客觀實力不足，主觀心態復趨於保守，導致企業之糾紛程序選擇權受到一定的限制。二、仲裁程序以當事人合意為前提，雙方就現在之爭議欲達成仲裁協議，本即有一定之難度。三、我國仲裁法未開放專利有效性糾紛之仲裁容許性，權利有效性問題仍待行政法院認定，致生程序切割及審理時程延宕之不利益。四、我國仲裁制度因仲裁人之公正、獨立性有待加強、證據法則規範不夠完整且未能落實，導致程序正義不彰，當事人對仲裁制度信賴感普遍不足。五、我國仲裁法未明文賦予仲裁人核准保全程序之權限，當事人仍須向法院聲請假扣押、假處分裁定，不但緩不濟急，法官對於應否進行保全程序及核准為何種保全措施，其掌握度亦不如仲裁人。六、我國非紐約公約簽約國，以致於我國仲裁判斷面臨難以於外國獲得承認及執行之困境。上述幾點，都是我國企業專利糾紛欲循仲裁程序解決所面臨之限制因素。 有鑑於專利仲裁於我國企業之主要活躍領域，即美國與中國，已逐步成熟發展，本文謹建議我國企業面臨專利糾紛程序選擇時，應考量糾紛之目的及類型，以決定是否適用仲裁程序。若適用之，則需作好仲裁策略規劃，對於仲裁協議、仲裁地、仲裁機構、仲裁人、仲裁程序均應為適當之安排，以爭取最有利之仲裁判斷。 本文最末則自短程及長程觀點，對我國專利仲裁之發展提出建議。短程而言，我國企業就單純的法律解釋爭議、訟爭性不高或彼此間存有持續性合作關係之專利契約，宜約定仲裁條款；就專利侵權糾紛則得透過互相退讓之方式，約定就專利有效性爭議不為爭執，或同意被告之損害賠償上限，以換取適用仲裁之空間。長程而言，於仲裁立法面，我國應於仲裁法或專利法明文開放專利糾紛之仲裁容許性、增訂仲裁程序之調查證據規範、明文立法賦予仲裁庭核准保全程序之權限；於仲裁制度面，應提升仲裁人之公正性、獨立性及自律性、加強仲裁人之專業及制訂專業之專利仲裁規則；於企業策略面，建議企業應依專利糾紛之目的及類型為適當之程序選擇，如適用仲裁程序，則應妥善配置仲裁要素，規劃出最有利之仲裁程序。 / As the knowledge-based economy rapidly grows today, patent rights has become one of the most valuable assets of corporation. Patent litigation becomes the most important commercial method to generate massive revenue in nowadays. Patents usually involve complicated technology and commercial elements and patent litigation procedure is usually complicated, time consuming and mostly very expensive. Hence, new solutions, which are more fair, reasonable, rapid, economic and professional, are proposed to replace litigations. In the U.S., the Congress approved 35 U.S.C. 294 in 1982 to regulate rules allowing dispute parties may voluntary initiate binding arbitration procedure in regard with patent validity and infringement issues. The UNCITRAL Model Law on International Commercial Arbitration enacted in 1985 offered as prototype of arbitration legislation for UN members. In 1994, the WIPO Arbitration and Mediation Center was established to offer professional and cross-broader Alternative Dispute Resolution (ADR) options for the resolution of intellectual property disputes between private parties. All these reforms show the development and growth of patent arbitration. Patent are characterized with limitations on period of protection, scope of claim and advanced technology. It involves with the knowledge of law, technology and commerce. Thus it will be required to deal with patent dispute with efficiency, profession, confidentiality, economic, flexibility, multi-nation and risk control when one decides which dispute resolution method to adopt, and arbitration is exactly the ADR method that satisfies all the requirements. Nevertheless, the exclusivity and the great commercial interests inherent behind patent litigation attract patentees to enforce their patent rights through courts regime. The difference in financial strength and interest leads to a difficulty for different parties to achieve an agreement. Extensive discovery procedure is almost compulsory in patent infringement litigation so that information between parties can be fully disclosed through the process. On the other hand, information disclosure is limited in arbitration proceedings. Also the parties may appeal a patent case in court, and it has an approximately 50% win rate in such attempt. All these factors decrease the parties’ intention to settle their case by arbitration. Through the case study and analysis of the Taiwan companies on patent litigation and arbitration history, it is not difficult to discover the deficiency of Taiwan’s current arbitration regime. The shortage in resource and unwillingness to take arbitral procedure restricts Taiwan companies to exercise they right to select dispute resolution procedure. Mutual consensus is the key priority for arbitration, but this could be extremely difficult to achieve on given patent dispute. Patent validity cannot be determined through the arbitration under current Taiwan Arbitration Law and needs to be determined by court, which prolongs the arbitral proceedings. Moreover, the professional ability of Taiwan’s arbitration remains in doubt, in terms of lack of fairness, independence and evidence rules, led the untrustworthiness of our arbitration regime. The arbitral tribunal has no authority to order interim measures, such as provisional seizure and preliminary injunction and Taiwan is not a signature party of New York Convention are also the factors that weaken the value of arbitration procedure in Taiwan. In comparison with the system in Taiwan, China and the U.S. patent arbitration are more systematized and are still increasing in numbers in both China and the United States. This thesis shall point out the factors for parties to consider adopting arbitration as patent dispute resolution, and assist parties to plan arbitration strategies. Lastly, this thesis will give suggestions on Taiwan’s patent arbitration regime development in both short and long terms. In short term, the public should be more aware the benefits by adopting arbitration clause in contract, when argument and disagreement might exist merely on obvious legal definition or less argument presented or when collaboration still exist between parties. This will encourage parties to agree to solve their dispute through arbitration in advance. In long term, legislators should regulate more detailed rules on arbitration procedure, evidence rules, and judicial support. Arbitration institutions should increase the training, improve the quality of arbitrators and develop more conscientious procedure rules. Corporation should have the concepts to learn and understand more about arbitration, and takes arbitration into consideration as commerce strategy in advance.

公共工程案件在適用政府採購法時，因其契約型態、性質與工程特性，往往容易產生諸多爭議，本文除了討論公共工程履約爭議的類型之外，同時也分析常見的爭議處理方法，也特別對於ADR等各種爭議救濟途徑的程序及效果進行比較。此外，對於日本的工程爭議處理機制也加以研究，介紹其法源、處理程序及法律效果等，並與我國履約爭議處理制度做一差異比較。 政府採購法於民國96年7月，政府採購法第85條之1修正實施，原條文第2項條文修正為「前項調解屬廠商申請者，機關不得拒絕；工程採購經採購申訴審議委員會（下稱申訴會）提出調解建議或調解方案，因機關不同意致調解不成立者，廠商提付仲裁，機關不得拒絕。」使得採購機關不得拒絕廠商提出仲裁的後續救濟途徑，強化採購申訴會調解建議或調解方案之地位。此舉促使採購機關在面對政府採購案件爭議調解不成立時，廠商得以選擇較為快速解決爭端的仲裁方式，不必進入冗長的訴訟程序，耗損不必要之程序上金錢及時間花費，亦有助紛爭提早解決。該條文的修正實施，開啟了先調後仲的強制仲裁機制，可以說是我國在公共工程爭議解決政策上的重大變革。不僅重新強化仲裁的爭議解決機制，同時也節省爭議處理的時間成本，不至於浪費社會資源。 惟新法的先調後仲制度實施至今，固然促使許多機關及廠商積極促成調解成立，但是在實務的操作上亦出現了許多的問題。本文從各種層面進行分析，探討各項實務上所可能面臨之問題作為討論重點，以期作為機關相關承辦人員及廠商之參考。 關鍵字：政府採購法第85條之1、先調後仲、公共工程履約爭議、工程爭議、工程契約、調解、仲裁、ADR、工程爭議處理機制。

Arbitration proceedings as a means of dispute resolution in international law with regard to the recognition and enforcement of foreign arbitral awards Resumé Arbitration as a method of settlement of disputes settlement has enjoyed growing popularity in recent several years. Arbitration stands between other alternative means of dispute settlement and the common court trial as a alternative dispute resolution. Although negotiation, good offices, mediation, conciliation, inquiry, mini-trial, medarb or meadaloa are often used forms of the dispute settlement their awards cannot be enforced by the state authority. Those means are popular mainly in the business field where the parties are interested in the cooperation and where they aim to clear up some misunderstanding or technical problems rather than solve major disputes between them. While the dispute should be solved by the binding way the parties would choose the arbitration as a legally framed procedure. Arbitral awards are then able to be enforced and the parties also have more exact boundaries for the whole procedure. However, there is no unified definition of the arbitration, it could be described as a legal technique where the parties bring claim before one or more neutral persons (arbiters or arbitral tribunal) by whose award the parties agree to be...

Cette thèse doctorale a pour objet l’étude et en particulier l’influence qu’a pu avoir, et qu’ont toujours, les puissances européennes sur la résolution des conflits en Afrique de l’Ouest et ainsi déterminer s'il existe une culture juridique « africaine ». / This thesis is devoted to the study the influence of the European powers on past and present dispute resolution in West African legal systems and thereby to determine whether an "African legal culture" exists.

Traditionnellement, le droit des entreprises en difficulté recourt à l’autorité judiciaire pour la mise en oeuvre de ses dispositions et la réalisation de ses finalités. Toutefois, considérant l’évolution de ce droit, le traitement « tout judiciaire » des difficultés des entreprises est remis en cause. En effet, il ne s’agit plus seulement de sanctionner, mais davantage de prévenir les difficultés et de sauvegarder les entreprises, ce qui dénature l’office juridictionnel. De plus, les commerçants ne sont plus les seuls concernés par ce droit, ce qui aboutit à l’éclatement de la compétence juridictionnelle. Il y aurait lieu d’envisager d’autres modes de traitement. Prenant en compte l’existence d’un traitement administratif, connu du surendettement, mais, aussi, des entreprises, et favorisant le règlement alternatif des difficultés, une autre voie peut être proposée pour la prise en charge de l’impossibilité économique d’exécuter. La légitimité du juge, dont les interventions seraient recentrées et la compétence spécialisée, en ressortirait renforcée pour le traitement des entreprises en difficulté. / Traditionally, insolvency law appeals to the judicial authority to apply its provisions and to carry out its aims. However, regarding the evolution of this law, the exclusive judicial treatment of the difficulties is challenged. Indeed, it is no longer only to punish but more to prevent difficulties and safeguard businesses, which distorts the judicial office of the judge. In addition, traders are not the only ones affected by this law, leading to the outbreak of jurisdiction. Subsequently, there is a need to consider other modes of treatment. Taking into account the existence of an administrative process, known by over-indebtedness, but also by businesses, and promoting alternative dispute resolution of difficulties, another path can be proposed for the management of the economic impossibility of performance. The legitimacy of the judge, whose interventions would be refocused and skills specialised, would be strengthened in relation to the treatment of undertakings facing difficulties

The diploma thesis is focused on alternative dispute resolution (ADR) in business relationships. The goal of thesis is to determine the term of alternative dispute resolution and to compare different approaches to regulation of mini-trial and mediation. The first part of thesis presents the term ADR and identifies its key characteristics. It points out the advantages and disadvantages of ADR and introduces institutions which concern with ADR. The attention is also aimed on arbitration and its relation to ADR. The second part of thesis deals with mini-trial. The description of its features is based on comparison of model rules provided by institutions which concern with ADR. The third part of thesis is focused on the most expanded method of ADR -- mediation. The attention is aimed at regulation trend within the European Union, legislation in the Czech Republic and Mediation Act Proposal. Closing part compares regulation of mini-trial and mediation and points out some of the debatable provisions of the Mediation Act Proposal.

Le travail réalisé a pris en considération en premier lieu le droit international privé de l'UE, puis des aspects plus à proprement parler de « droit international procédural », en se concrétisant par une « systémisation » et une cartographie des voies de recours proposées au consommateur par le droit européen pour les litiges transfrontaliers. La première partie, concernant la loi applicable aux contrats internationaux du consommateur et le tribunal compétent dans le droit international privé de l'Union européenne, permit d'identifier les problématiques de droit international privé sous-jacentes aux contrats et aux litiges internationaux en matière de consommation, qui sont exacerbées dans le domaine du commerce électronique. La thèse traite deuxièmement la protection du consommateur par l'assouplissement et la simplification des procédures ordinaires et la protection du consommateur par des procédures collectives transfrontalières. Enfin, la thèse concerne la protection du consommateur par les procédures alternatives au contentieux ordinaire. / The thesis analyzes, under various aspects related to private international law and international civil procedure of the European Union, the status of the protection offered to the European consumers in their international contracts, in particular in relation to the objectives and in the context of the single market. The thesis is divided into three chapters. The first chapter deals with consumer protection in the international private law of European Union (regulation (UE) 1215/2012 and regulation (CE) 593/2008). The second chapter deals with the protection offered to consumers by european international civil procedure with reference to individual and collective litigations. The third chapter deals with alternative dispute resolution (ADR) and with on-line dispute resolution (ODR) and analyzes EU directive 2013/11/UE and regulation (EU) 524/2013. / La tesi analizza, sotto vari aspetti relativi al diritto internazionale privato e processuale dell’Unione Europea, lo stato della protezione offerta al consumatore europeo nei contratti e nelle controversie internazionali, con uno specifico riguardo alle tutele di carattere processuale e giurisdizionale. La tesi si articola in tre capitoli, che investono gli ambiti in cui tale tutela può esplicarsi, ovvero, l’individuazione di un foro e di una legge applicabile favorevoli agli interessi del consumatore, la semplificazione delle regole di procedura nelle controversie individuali internazionali, la possibilità di dare luogo a procedimenti transfrontalieri collettivi e la creazione di un sistema efficace di risoluzione delle controversie internazionali in via stragiudiziale anche on-line. Il primo capitolo ricostruisce dapprima il sistema di diritto internazionale privatodell'Unione europea in materia di contratti di consumo, dando conto del contesto politico ed economico in cui si inserisce ed alla cui luce devono esserne letti gli obiettivi. Vengono quindi individuati i principi e gli obiettivi che fondano le norme di diritto internazionale privato in materia di contratti internazionali del consumatore, le quali si caratterizzano per l’essere ispirate a finalità materiali, ovvero, volte a permettere di individuare un foro competente ed una legge applicabile che siano in grado di bilanciare tra loro le esigenze dei consumatori e degli operatori del mercato, con la conseguenza di favorire l’esplicarsi degli scambi commerciali e della concorrenza nel mercato unico. Ciò avviene garantendo al consumatore l’applicazione della legge e la competenza del foro a lui più prossimi, ovvero quelli del suo paese di residenza abituale (la cui coincidenza permette peraltro una riduzione dei costi delle liti transfrontaliere) e la prevedibilità delle soluzioni agli operatori del mercato.Il capitolo traccia quindi lo sviluppo normativo e giurisprudenziale delle norme di diritto internazionale privato europee in materia di contratti del consumatore, prendendo in particolare in considerazione le più recenti sentenze della Corte di Giustizia che, dal 2010 ad oggi, hanno ridefinito l’ambito di applicazione delle norme contenute nel regolamento (CE) 44/2001 (Bruxelles I), oggi rifuso nel regolamento (UE) 1215/2012 (Bruxelles I-bis), e nel regolamento (CE) 593/2008 (Roma I), insistendo sulla definizione del concetto, volutamente aleatorio, di “attività diretta” e sul suo ruolo di preminenza nel connettere la fattispecie contrattuale allo Stato della residenza del consumatore per permetterne la competenza dei giudici e l’applicabilità della relativa legge. Viene svolta infine una analisi critica sull’interpretazione fornita dalla Corte di Giustizia che rischia, nel concreto, di rendere le norme in oggetto applicabili in maniera variabile dai giudici nazionali, garantendo alle volte una tutela troppo estesa o troppo ristretta al consumatore, senza riguardo per l’esigenza di certezza giuridica degli operatori del mercato.

Qualified persons in the field of occupational risks Abstract Qualified persons in the field of occupational risks are persons dealing with different levels of risk, different extent and type of risks. In this set is not only the person for health and safety, but there are other qualified persons as well. For example, a qualified person who provides and performs the ccupational health services, a qualified person for fire protection, a construction safety coordinator, as well as an inspection technician of dedicated technical equipment, etc. A key qualified person in occupational risk and health and safety prevention is a person who assist employers in occupational risk prevention by managing risk identification, providing risk assesments, identification of source and risks causes and incidents. This person takes care about risk factors on worplaces such as microclima, chemical and biological hazards, noise, ergonomy and many others risks and continuosly advises employers of identificated risk on workplaces. He leads as a expert in health and safety, but not responsible, for applying right and effective principles of work safety and accident prevention and provide high qualified consultating job for employers. As well as is need to be noticed that employers has a legal obligation to have minimum one these...