...UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2009 TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE EXCHANGE ACT For the transition period from to Commission File No. 0-28882 WORLD HEART CORPORATION Delaware (State or other Jurisdiction of Incorporation or Organization) 4750 Wiley Post Way, Suite 120 Salt Lake City, Utah USA (Address of Principal Executive Office) (801) 355-6255 (Registrant’s Telephone Number) Securities registered pursuant to Section 12(b) of the Exchange Act: Title of each class Name of each exchange on which registered 52-2247240 (I.R.S. Employer Identification No.) 84116 (Zip Code) Common Stock, $0.001 par value NASDAQ Capital Market Securities registered pursuant to Section 12(g) of the Exchange Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes No Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. Yes No Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements...
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...Question 1: Considering both economic and ethical aspects, is it appropriate for companies like Novo Nordisk to conduct clinical trials in, for example, India, and if so under what conditions? What exactly are the principles that should guide such a decision? 1. Ethical aspect. Nordisk’s implementation of clinical trials in India is appropriate. The appropriateness is expressed through the following guidelines: • Novo Nordisk’s trials seriously comply with medical ethics (Hippocrates’s oath) through its particular attention to individual patients joining any of its trials. • Novo Nordisk has applied all the guidelines and global recommendations from specialized agencies and has adopted its policies on clinical trials. Accordingly: o Clinical trials sponsored by the company always comply with Helsinki Declaration, listing the rights of patients enrolled in clinical trials, and the global ethical principles like Nuremberd rules, and Belmont report, CIOMMS and the principles of the International Conference of Harmonization on Current Clinical Practice (CGCP) o Countries where Novo Nordisk conducts trials will be ensured to have a proper internal organization and proper legal environment. o No testing activities are conducted before permitted by the ethics review board and the health authorities. o The safety information of Novo Nordisk’s trials will be continuously monitored and appropriate actions will be taken if risks of the tried medicine outweigh the...
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...Question 1: Considering both economic and ethical aspects, is it appropriate for companies like Novo Nordisk to conduct clinical trials in, for example, India, and if so under what conditions? What exactly are the principles that should guide such a decision? 1. Ethical aspect. Nordisk’s implementation of clinical trials in India is appropriate. The appropriateness is expressed through the following guidelines: • Novo Nordisk’s trials seriously comply with medical ethics (Hippocrates’s oath) through its particular attention to individual patients joining any of its trials. • Novo Nordisk has applied all the guidelines and global recommendations from specialized agencies and has adopted its policies on clinical trials. Accordingly: o Clinical trials sponsored by the company always comply with Helsinki Declaration, listing the rights of patients enrolled in clinical trials, and the global ethical principles like Nuremberd rules, and Belmont report, CIOMMS and the principles of the International Conference of Harmonization on Current Clinical Practice (CGCP) o Countries where Novo Nordisk conducts trials will be ensured to have a proper internal organization and proper legal environment. o No testing activities are conducted before permitted by the ethics review board and the health authorities. o The safety information of Novo Nordisk’s trials will be continuously monitored and appropriate actions will be taken if risks of the tried medicine outweigh the benefits it brings...
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...required of me and my investigators? ▪ The OHSRP website: https://federation.nih.gov/ohsr/nih/investigator-training.php, divides training by type of research conducted. Training curricula are specified as Clinical Research, Epidemiological and Social Behavioral Research, and Basic Science Research. ▪ Each type has a link associated with it that when accessed, instructions are given, required courses and Just-in-Time/optional courses are listed, and the training links to each course are provided. ▪ Just-in-Time CITI courses may be required by the IRB or PI if an investigator is conducting research involving certain specialized areas, but are otherwise optional (e.g. GCP courses are optional, for research staff who do not conduct FDA-regulated research.) IRBs or PIs may also require Key Research Personnel to complete these courses. . How do I choose between the CRT, CITI Biomedical and the NIH CC Ethics course? ▪ CITI courses offer a “test-out” option. If you achieve a score of 80%, you will not be required to take the full course. ▪ CITI also offers the option to take the full course with CMEs (fee required). ▪ The NIH CRT can be accessed without an NIH login. ▪ The Ethical and Regulatory Aspects of Clinical Research course is an in-person course offered annually by the CC Bioethics Department. It can be taken as the primary training course, as well as a refresher course in place of the CRT or the CITI Biomedical course...
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...required of me and my investigators? ▪ The OHSRP website: https://federation.nih.gov/ohsr/nih/investigator-training.php, divides training by type of research conducted. Training curricula are specified as Clinical Research, Epidemiological and Social Behavioral Research, and Basic Science Research. ▪ Each type has a link associated with it that when accessed, instructions are given, required courses and Just-in-Time/optional courses are listed, and the training links to each course are provided. ▪ Just-in-Time CITI courses may be required by the IRB or PI if an investigator is conducting research involving certain specialized areas, but are otherwise optional (e.g. GCP courses are optional, for research staff who do not conduct FDA-regulated research.) IRBs or PIs may also require Key Research Personnel to complete these courses. . How do I choose between the CRT, CITI Biomedical and the NIH CC Ethics course? ▪ CITI courses offer a “test-out” option. If you achieve a score of 80%, you will not be required to take the full course. ▪ CITI also offers the option to take the full course with CMEs (fee required). ▪ The NIH CRT can be accessed without an NIH login. ▪ The Ethical and Regulatory Aspects of Clinical Research course is an in-person course offered annually by the CC Bioethics Department. It can be taken as the primary training course, as well as a refresher course in place of the CRT or the CITI Biomedical course...
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...7/1/2011 Contents Introduction 2 What is clinical research? 2 The state of health in India 2 Clinical Research Market in India 3 Factors that Continue to Make India Attractive for Future Clinical Trial Outsourcing: 4 Challenges for the Indian Clinical Research Industry 6 Cinical research profession 7 Conclusion 8 Introduction Successful persons in business are noted to be blessed with innovation, perseverance and a broad vision. Its critical to have the “big picture” in mind while we want to position and well-establish the smallest things, after all the intensity of effect that something can cause cannot be under-estimated. A tiny sim-card that provides enormous data and communication coverage, an atom bomb which caused ruthless destruction in Japan, a small silicon chip that provides powerful processing speed in our computers, a tablet of aspirin that at times saves life; none can be ignored. It is important, thus, to identify the patterns, the trends, the relationships between smaller items in the “big picture” to channelize our efforts towards a unique direction. Behind every innovation lies a unique idea, and behind every successful idea lies the large audience it will cater to. Clinical research is one such area that can help a large population with some of their grave needs through small yet life-changing discoveries. What is clinical research? As per wikipedia.com, “Clinical research is a branch of medical science that determines the...
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...Key Personnel Group 3: IRB Member module. This course consists of 4 subparts on IRB membership for current IRB members. This course should not be attempted until a Basic Human Subjects Course is completed. Choose this learner group and follow the link to the Basic Course. Good Clinical Practice and ICH: This course consists of 13 modules on GCP and ICH E6 for invetigators. This Basic GCP course should not be attempted until the Basic Human Subjects Course is completed. Choose this learner group and follow the link to the Basic Course. Lab Animal Welfare: Select this response to bypass the Human Subjects Course Go to Question 3 for the Lab Animal Course and select the appropriate response. 2. CITI HUMAN SUBJECTS (REFRESHER) Select the group for which you have previously completed an institutionally approved Basic Course in the Protection of Human Research Subjects. https://www.citiprogram.org/dev/enroll/selectgroups.asp?strKeyID=3FE2B565-AC6F-40C... 2/28/2008 Select Curriculum Page 2 of 3 Choose one answer Group 1.: Biomedical Research Investigators and Key Personnel. Group 2.: Social / Behavioral Research Investigators and Key Personnel Good Clinical Practice and ICH: This course consists of 13 modules on GCP and ICH E6 for invetigators. This Basic GCP course should not be attempted until the...
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...ADVANCED WORKSHOP : REVIEW OF DRUG DEVELOPMENT IN CLINICAL TRIALS BANGKOK, 2-6 FEB 2009 Opening and Welcome Speech Mrs Werawan Tangkeo The Deputy Secretary General of Thai Food and Drug Administration @ The Siam City Hotel, Bangkok 2-6 February 2009 Dr Viner, Dr Stevens, Dr Sato, and Dr Sudhichai, Distinguished participants, Ladies and Gentlemen: It gives me a great pleasure to welcome all of you and chair the Opening Ceremony this morning to the “Advanced Workshop: Review of Drug Development in Clinical Trials” jointly organized by Asia Pacific Economic Co-operation and Food and Drug Administration, Thailand. The significance of Drug Clinical Trials and Capacity Building for Drug Regulatory Agencies are well noticed by several international networks including ASEAN or Association of South East Asian Nations, APEC or Asia Pacific Economic Cooperation, and ICH Global Cooperation Group. This project has been endorsed by ASEAN Working Group on Technical Cooperation in Pharmaceutical (AWGTCP), APEC Life Sciences Innovation Forum (LSIF) and ICH Global Cooperation Group (GCG) since the year 2002, 2006 and 2007, respectively. By the listed international cooperation, indeed, we have received technical, financial, and moral supports. Please allow me to recall the last year achievement of hosting 2 training workshops in Thailand, those are “Preliminary Workshop : Review of Drug Development in Clinical Trials” and “Basic Workshop on GCP/ Clinical Research Inspection”. The accomplishments of...
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...Clinical supervision continues to be a term evident in everyday language in nursing and definitions of the term are variable. Definitions suggest it has a broad purpose in nursing and can appear to have a lack of accord and focus. Jones (1999) suggests that clinical supervision offers nurses guidance, support and education and is concerned with quality, safety and protection of clients which reflects the Department of Health ‘Vision for the Future’ (1993) interpretation of clinical supervision as a: ‘formal process of professional support and learning which enables individual practitioners to develop knowledge and competence, assume responsibility for their own practice and enhance consumer protection and safety of care in complex situations. It is central to the process of learning and to the scope of the expansion of practice and should be seen as a means of encouraging self assessment and analytical and reflective skills.’ The following assignment aims to demonstrate a critical appraisal of the concept of clinical supervision, critique the process and the outcomes of clinical supervision and review contemporary research that directly informs understanding and application of clinical supervision to practice. It will also reflect on personal knowledge, skills and attributes required for effective clinical supervision and evaluate the impact that clinical supervision has on health and social care practice with the emphasis on my professional discipline of nursing/ mental...
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...This assignment will evaluate and explore the experience of mentoring a student in practice, critically analysing topics that will reflect on the role of the mentor, within the context of the nursing profession. The placement area concerned is a 14 bedded acute elderly assessment ward, which caters for both male and female patients. Several students have been placed on our ward over the years, it is the mentors responsibility to provide students with appropriate support, guidance and supervision within the clinical environment, Myall 2008. One of the key issues that need to be considered in preparation for an effective learning environment would be making sure the student is aware of the situations that could arise on the ward, discussing typical events that could happen on a daily basis. clinical experience can be a stressful part of the nursing program, working in a unfamiliar area, working with difficult patients and the fear of making mistakes. Hutchinson (2003) believes that a teacher should aim to provide an environment in which learners feel safe to experiment, voice their concerns, identify their lack of knowledge and stretch their limits. One of the major factors affecting learning is the environment in which it takes place. It is the responsibility of professional staff to create and develop an environment conductive to learning (Price, 2004). This implies that the environment should be continually monitored...
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...This essay will discuss a clinical skill in which I have become competent in practicing. I will use a reflective model to discuss how I have achieved the necessary level of competence in my nurse training programme. The reflective model I have chosen to use is Gibbs model (Gibbs 1988). Gibbs model of reflection incorporates the following: description, feelings, evaluation, analysis, conclusion and an action plan (Gibbs 1988). The model will be applied to the essay to facilitate critical thought, relating theory to practice where the model allows. Discussion will include the knowledge underpinning practice and the evidence base for the clinical skill. A conclusion to the essay will then be given which will discuss my reflection skills, acknowledge my competence and show my personal and professional development. The clinical skill I have chosen to reflect on within this essay is the administration of Intramuscular (IM) injections. I have chosen this as within my first clinical placement this was a widely used method of drug administration and I became involved in the process of IM injections. I therefore researched the topic of IM injections and my knowledge within this area developed. The first stage of Gibbs (1988) model of reflection requires a description of events. I was asked to administer a drug to a patient via IM injection. I had observed this clinical skill on a variety of occasions and had previously administered an IM injection under supervision. On this occasion I...
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...practice is possibly the most important element of Personal Mastery since this self-motivational ability will be an fundamental driving force. Clinical Leadership within the Trust to sustain clinicians in both clinical practice and education/training settings is presently provided through clinical supervision and mentorship by the Clinical Directorate Team. This team will have need of further development of their own leadership skills, mostly to support the newly qualified graduate paramedics and nurses entering clinical practice. An added tier to the leadership umbrella will be the clinical team leader role. These individuals will offer a key function through the monitoring and obedience to protocols and routine clinical performance indicators...
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...MENTORING IN PRACTICE MODULE CODE: MOD001840 SID NO : 0711950 WORDS : 2,000 SUBMISSION DATE: 10TH OF MAY 2013 The purpose of this essay is to provide a reflective account of mentoring a pre-registration nursing student in practice. A reflective model (Gibbs 1988, appendix 1) I will analyse the experience between myself as a mentor and the student under the supervision of a qualified mentor. The learning styles, The name of individuals involved shall not be mentioned in order to protect confidentiality in accordance to the Nursing and Midwifery Council (NMC, 2008) Emphasis will be put on how an environment may be created to foster a long life learning and teaching and the learning strategies that were utilised, coupled with principles of assessment and the assessment tools that were used. The role of a mentor in facilitating learning will also be appraised. What is reflection? According to, Taylor (2000), “reflection means the throwing back of thoughts and memories in cognitive act such as thinking, contemplation, meditation and any other form of attentive consideration in order to make sense of them, and to make contextually appropriate changes if they are required”. The purpose of reflection as stated by John (1999) is to promote desirable practice through the practitioner's understanding and learning about their lived experiences. John (1999) mentorship reflection. This mentorship encourages practitioners to work through a series of reflective...
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...This assignment will evaluate and explore the experience of mentoring a student in practice, critically analysing topics that will reflect on the role of the mentor, within the context of the nursing profession. The placement area concerned is a 14 bedded acute elderly assessment ward, which caters for both male and female patients. Several students have been placed on our ward over the years, it is the mentors responsibility to provide students with appropriate support, guidance and supervision within the clinical environment, Myall 2008. One of the key issues that need to be considered in preparation for an effective learning environment would be making sure the student is aware of the situations that could arise on the ward, discussing typical events that could happen on a daily basis. clinical experience can be a stressful part of the nursing program, working in a unfamiliar area, working with difficult patients and the fear of making mistakes. Hutchinson (2003) believes that a teacher should aim to provide an environment in which learners feel safe to experiment, voice their concerns, identify their lack of knowledge and stretch their limits. One of the major factors affecting learning is the environment in which it takes place. It is the responsibility of professional staff to create and develop an environment conductive to learning (Price, 2004). This implies that the environment should be continually monitored...
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...the teaching, training and mentoring of adults occur. The essay will explore the writer’s understanding regarding the role of a mentor within the workplace and the theoretical ties surrounding mentorship and how these are linked into the writer’s role of a mentor. Any names or areas of work mentioned in the essay have been changed in order to maintain confidentiality, clause five of the Nursing and Midwifery Council (NMC) Code of Professional Conduct: Standards for Conduct, Performance and Ethics (NMC 2004). The term ‘mentor’ is defined by the English National Board (ENB) and the Department of Health (DOH) to “denote the role of the nurse, midwife or health visitor who facilitates learning and supervises and assesses students in their practice setting” (ENB & DOH 2001a P6). Nicklin and Kenworthy (2000) define a mentor as someone who by example and facilitation guides, assists, and supports the student in learning new skills, adopting new behaviour and acquiring new skills. Quinn (2000 P.427) furthers this definition by pointing out the fact that a mentor is someone who “enters into a formal arrangement to provide education and personal support to a student throughout the period of the placement.” This denotes the level of responsibility and commitment required by the mentor, as an agreement is established. Within that agreement a contract of...
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