From Concept to a Published Paper - a guide to excellence in Medical Research.

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1 The Course Directors of the New Frontiers in Interventional Cardiology (NFIC), Krakow Cardiovascular Research Institute (KCRI) and Proper Medical Writing (PMW) would like to welcome you to the seminar: From Concept to a Published Paper - a guide to excellence in Medical Research. The seminar will take place on the 3rd of December 2014 between and and will be followed by Publish or Perish - A Truth or a Myth?, a 90 minutes open session with editors of cardiology journals. The open session will be held during the 7th European Interventional Cardiology Fellows Course. Speakers Rosemary Bischoff, MSc Thomas F. Lüscher, MD, FACC, FESC, FRCP Zbigniew Siudak MD, PhD Meeting facilitators Grzegorz L. Kałuża, MD, PhD Łukasz Partyka, MD, PhD Łukasz Kołtowski, MD, PhD

2 Participant Profile and Objective This interactive symposium is aimed at clinicians, scientists and investigators who have already become familiar with the complexities of medical research and publishing, and who would like to deepen their understanding of the processes especially in the field of cardiology. Participants will be asked to provide questions beforehand reflecting their specific interests. List of topics The seminar will be tailored to the interest of the participants. The most frequently asked questions (see above), will guide the specific content. The questions should come from the following areas: Selecting a type of clinical trial and the consequence for publication: registry vs. RCT, superiority vs. non-inferiority, placebo as comparator, hard endpoints vs. short surrogate endpoints, defining the study population (inclusion & exclusion criteria) and consequences of these criteria for the generalizability of the study. Statistical techniques and the consequence for publishing: sample size calculation, systematic review and metaanalysis [characteristics of good systematic review and metaanalysis and their place in the hierarchy of medical evidence (EBM)]. The critical review of scientific papers: the speakers will select 3 typical cardiology publications and point out the strengths and weaknesses of the papers and the trials they describe. Guiding principles for publication: good practice in manuscript preparation (including data presentation) for journals and congress presentations, strategy of publication (topic selection, selection of journal), how to recognize a good journal - is it only impact factors (IF) that matters? The seminar will be held in English. All participants will receive a certificate of attendance and will be awarded CME credits. Proper Medical Writing Sp. z o.o. Nowy Świat 35/2a Warszawa

3 Programme Registration and morning coffee Welcome Planning a clinical trial Rosemary Bischoff, M.Sc.; Lunch Guiding principles for publication Thomas F. Lüscher, MD FACC, FEST, FRCP The critical review of scientific papers Rosemary Bischoff, M.Sc.; ; Zbigniew Siudak MD, PhD Venue ICE Krakow (17 Konopnickiej St, Krakow) Price 100 EURO or 400 PLN Payment details provided at registration site Registration For the seminar From Concept to a Published Paper a Guide to Excellence in Medical Research go to: registration.nfic.pl The number of participants is limited.

4 Speakers Rosemary Bischoff, M.Sc. Rosemary Bischoff has been in the pharmaceutical industry since 1974, firstly, as a clinical project leader at Schering AG in Berlin where she was responsible for the design, conduct, reporting and publishing of numerous clinical studies. In 1998 she started her own medical writing business, ClinWrite. She also teaches Good Study Design, both as a regular workshop leader for EMWA as well as in customized workshops. Zbigniew Siudak MD, PhD Zbigniew Siudak MD, PhD is an interventional cardiologist working at the University Hospital and Institute of Cardiology Jagiellonian University Medical College in Krakow, Poland. He graduated from Medical Faculty in Krakow in 2004 and defended PhD thesis in He has co-authored over 70 research papers in respected cardiovascular journals and has been an active speaker and panelist at EuroPCR, TCT, ESC and NFIC congresses. In 2008 he worked in the Heart Center in Linköping, Sweden as a part of his specialist training. He served as a member of Scientific Programme Committee EAPCI ESC from 2009 to He is Editor-in-Chief of Cardio.pl, Co-Director of NFIC and an experienced lecturer in medical statistics and EBM. Adam is an experienced medical writer and statistician. Before setting up Dianthus Medical in 1999, he worked as a medical writer for both a small contract research organisation and a large medical communication agency. Adam has a PhD in organic chemistry from the University of Cambridge and an MSc in medical statistics from the London School of Hygiene and Tropical Medicine. He takes an active role in the European Medical Writers Association (EMWA), and was president of the association in In 2003, he set up EMWA s ghostwriting task force, as a result of which he was co- -author of EMWA s guidelines on the role of medical writers in peer-reviewed publications. He is a regular workshop leader for EMWA s training workshops and a columnist in their journal, The Write Stuff, and was among the first few people to be awarded EMWA s advanced professional development certificate. He is also a fellow of the Institute of Clinical Research and a Chartered Scientist. Proper Medical Writing Sp. z o.o. Nowy Świat 35/2a Warszawa

5 in particular in patients with hypertension, hyperlipidemia, coronary artery disease, chronic inflammatory diseases, acute coronary syndromes and heart failure. Thomas F. Lüscher, MD, FACC, FESC, FRCP Professor and Chairman of Cardiology and Director, Center for Molecular Cardiology, University Hospital and University of Zurich, Zurich, Switzerland Dr. Lüscher studied medicine at the University of Zurich and obtained a board certification of internal medicine as well as cardiology. He trained in cardiovascular research as well as in echocardiography at the Mayo Clinic in Rochester, MN, USA and was Professor of Pharmacotherapy at the University of Basel, then Professor of Cardiology at the University of Berne, before assuming his current position as Professor and Chairman of Cardiology at the University Hospital Zurich. In addition to his clinical and administrative responsibilities as Head of Cardiology, Professor Lüscher is Director of the Center of Cardiovascular Molecular Cardiology, Schlieren Campus, Institute of Physiology, University of Zurich, Switzerland. Since 2014 he leads the University Heart Center in Zurich together with his surgical colleague. Professor Lüscher has published extensively, authoring or co-authoring a large number original research articles and review articles including the ESC Textbook of Cardiovascular Medicine. By the Institute for Scientific Information he has been rated as one of the 0.5% most cited scientists worldwide. He has obtained awards of the European Society for Clinical Investigation, the Swiss Society of Cardiology, the Swiss Society of Internal Medicine, the World Congress of Cardiology and the Mayo Alumni Association and he is member of many editorial boards and was Associate Editor Europe of Circulation and currently is editor-in-chief of the European Heart Journal. Professor Lüscher s research interests focus on the role of endothelium-derived mediators in the regulation of vascular tone, platelet-vessel wall interaction, and coagulation as well as vascular structure in aging, hypertension, hyperlipidemia, and atherosclerosis. The mission of his clinical research focuses is the translation of basic research to humans,

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