KIEV CLINICAL RESEARCH FORUM 2017

About [/#sp-about-wrapper] Speakers Venue Event location Sponsors & Partners Schedule Organisers Sponsorship opportunities Register Contact us Kiev Clinical Research Forum The global discussing platform for the clinical research industry in Eastern Europe November 9 -10, 2017 Kiev, Ukraine Time passed: 1 1 0 0 9 9 5 5 Days 0 0 6 6 Hours 0 0 7 7 Minutes 2 2 2 2 Seconds WHO SHOULD ATTEND • Sponsors, CROs and Clinical Trial Vendors • R&D • Clinical Operations • Scientific & Medical Affairs • Regulatory Specialists • Clinical Purchasing & Outsourcing • Clinical Quality Assurance & Compliance • Clinical Trials Vendors • CRO Business Development The conference will be considering the topics: • ICH-GCP: Implementation roadmap for ICH E6 (R2) • Risk Based approaches in clinical trials: risk based monitoring, quality tolerance limits, e-health records in the context of risk based monitoring • Clinical trial regulations: the EU, Ukraine • Site management: success story of the leading Ukrainian oncology site • Regional focus on emerging markets: Ukraine, Albania • Clinical Operations: overcoming challenges in CNS, Paediatric, Cardiovascular and Orphan Diseases trials • Medical affairs: DSMB practices, craft of art in medical monitoring • The new patient advocacy and recruitment: the social media blueprint • Outsourcing strategies: metrics in collaboration between Sponsor and CRO; virtual CRO model; qualification of clinical trial vendors • Technologies: innovative solutions that will transform clinical trial arena KEY NOTE Mr. Amer Alghabban The industry’s fundamental challenges. The “best” times & the “worst” times. Basic facts. Socio-economic trends shaping the pharma marketplace. Issues that will have a major bearing on the industry over the next 10 years. Opportunities for Future Value . Amer is helping pharmaceutical companies to achieve compliance with GCP, GVP and GLP. Prior to that, he held a number of high ranking positions including Vice President at Karyopharm Therapeutics, Global Director, Head of Quality Assurance at Merck Serono. And he was the first Pharmacovigilance Compliance Officer of the MHRA. Mr. Alghabban was the Assistant Editor for 11 medical journals. Mr. Alghabban has published 2 reference books, The Pharmaceutical Medicine Dictionary and The Dictionary of Pharmacovigilance. He has been an invited speaker at over 102 international congresses, universities and the UN. ABOUT THE FORUM The 1st Kiev Clinical Forum is a global clinical research event in Eastern Europe combining the global vision on pharmaceutical and medical devices industries and the regional focus on emerging markets. This event aims to bring together international experts from industry, regulatory agencies, academia and non-profit boards to share views and knowledge on clinical research among all the participants, providing networking opportunities and adequate discussion between speakers and audience. WHY ATTEND • 300 delegates from the US, the EU, Ukraine, Turkey and Switzerland • Very affordable registration fee for this high level of the event • Excellent networking in the friendly atmosphere • Meaningful presentations from the best industry experts • Interactive roundtable discussions on the actual topics • Forum’s speakers are thoroughly selected and featured as most brilliant experts and pioneers in their particular fields. Being full of passion for clinical research, they are the individuals who add the drive that is immanent to the clinical research industry. All speakers are committed to be generous in communications to share their exciting experiences with the conference attendees. • Organiser warrants to refund the registration fees to all the delegates who will not find the attendance of the conference helpful for the lack of meaningful sessions and poor networking. Register Now Contact Us 1147 PARTICIPANTS 47 PRESENTATIONS 37 PANEL DISCUSSIONS 44 SPEAKERS FEATURED SPEAKERS Liudmyla Kovtun Deputy Director of State Expert Centre on Clinical trials of Ministry of Health (Ukarine) PhD, 60 published works. One of the key policy makers of clinical trial regulatory environment in ... Liudmyla Kovtun Deputy Director of The State Expert Center of the Ministry of Health of Ukraine on Clinical Trials (Ukraine) PhD, 60 published works. One of the key policy makers of clinical trial regulatory environment in Ukraine. Professional activities: expert evaluation of preclinical and clinical studies, development of clinical trial regulations at the national level. Martine Dehlinger-Kremer EUCROF President (Germany) Dr. Martine Dehlinger-Kremer is President of EUCROF , the European CRO Federation; Vice President, Global Medical and Regulatory Affairs at SynteractHCR , a CRO with headquarters in California and 11 other offices internationally. ... Martine Dehlinger-Kremer Dr. Martine Dehlinger-Kremer is President of EUCROF , the European CRO Federation; Vice President, Global Medical and Regulatory Affairs at SynteractHCR , a CRO with headquarters in California and 11 other offices internationally. She is also a Board member of EFGCP (European Forum for GCP). Dr. Dehlinger-Kremer has 30 years of experience in the clinical research industry, including more than 27 years of progressively higher levels of Regulatory and Medical Affairs leadership responsibility. Dr. Dehlinger-Kremer has contributed to the global development of numerous products, including orphan drugs and biosimilars. She has participated in more than 100 New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs) globally and in numerous clinical studies across all phases. Dr. Dehlinger-Kremer has served as Chair of the Paediatric Working Group of EUCROF since 2008 and has influenced the standards, protocols and number of trials conducted for drugs being administered to children. Dr. Dehlinger-Kremer is chair of the EFGCP Children Medicines Working Party. Dr. Dehlinger-Kremer is also Member of Working Parties of Enpr-EMA, the European Network of Paediatric Research at the European Medicines Agency. Dr Dehlinger-Kremer was Named One of PharmaVOICE 100’s Most Inspiring People in Life Sciences (Industry leader recognized for impact, experience and advocacy in clinical research) in August 2015. Marcin Stefanowicz Medical and technology innovator and clinical trial professional Currently joined with leading biopharmaceutical company Roche and leads Regional Study Manager ... Marcin Stefanowicz Medical and technology innovator and clinical trial professional. Currently joined with leading biopharmaceutical company Roche and leads Regional Study Manager position for Central and Eastern Europe. Solely responsible for several international clinical trials from Western to Eastern Europe in several therapeutic areas: inflammatory, immunology, arthritis, oncology (many indications), neurology (adult and paediatric population), cardiology (medical device) dermatology. As medical technology passionate leads some innovation ideas and project in Europe at IDEA Network Group at Roche. As Ambassador role of this IDEA Roche group, responsible for new technological innovation implementation around the patient-centricity approach and innovation thinker and promoter of the great idea about process, procedures and medication development optimization approach at clinical operational level. Jeffrey T. Apter President of Global Clinical Trials LLC (USA) Jeffrey T. Apter, M.D., President of Global Clinical Trials LLC, President and Medical Director of Princeton Medical Institute and Global Medical Institutes LLC, directs clinical trials in the areas of CNS and especially Alzheimer’s ... Jeffrey T. Apter Jeffrey T. Apter, M.D., President of Global Clinical Trials LLC, President and Medical Director of Princeton Medical Institute and Global Medical Institutes LLC, directs clinical trials in the areas of CNS and especially Alzheimer’s disease. Dr. Apter has been the Principal Investigator for over 100 trials in Depression, Anxiety disorders, Bipolar Disorder, Schizophrenia and Alzheimer’s Disease. Dr. Apter, a nationally renowned psychopharmacologist, is a senior attending physician at the University Medical Center at Princeton and a research collaborator in the Department of Psychology at Princeton University. Dr Apter has been actively involved in the Alzheimer Association as is a member of the NJ Alzheimer Association Scientific Advisory Board. Donato Bonifazi CEO, Consorzio per Valutazioni Biologiche e Farmacologiche (Italy) Economist specialised in European Project Management, Project Manager of the EU-funded Projects involving a number of partners from Europe, North America and North Africa. e. F Donato Bonifazi Economist specialised in European Project Management, Project Manager of the EU-funded Projects involving a number of partners from Europe, North America and North Africa. Acting as non-profit Sponsor, he is strongly involved in the enhancement of paediatric research. He is member of the Paediatric Working Group of the EUCROF and coordinator of the TEDDY - European Network of Excellence for Paediatric Clinical Research, an independent Research Network (category 1 network member of Enpr-EMA, the European Network of Paediatric Research at the European Medicines Agency), composed by 48 partners from 19 EU and non-EU countries aimed at facilitating the performance of good quality paediatric studies and research. Donato Bonifazi is involved in the PedCRIN (Paediatric Clinical Research Infrastructure Network - GA 731046, INFRADEV-3-2016) project as WP3 Leader, dedicated to the development of tools to facilitate paediatric clinical trials. The PedCRIN Project is very important, as it represents the first step in the design of the new European Paediatric Research Infrastructure. Dagmar Chase CEO, Clinrex (Germany) Dagmar Chase graduated in Computer Science with a secondary focus on Theoretical Medicine from the Technical University in Munich and has a PhD in Human Biology from the Medical Faculty of the University in Ulm, Germany ... Dagmar Chase Dagmar Chase graduated in Computer Science with a secondary focus on Theoretical Medicine from the Technical University in Munich and has a PhD in Human Biology from the Medical Faculty of the University in Ulm, Germany. Dagmar Chase co-founded the company GMI, a full service CRO, in 1983. Besides developing GMI into one of the largest CROs in Germany, she concentrated on Quality Management as well as the development of training programs for the pharmaceutical industry. Dagmar Chase was instrumental in the merger of GMI with the US-based CRO Kendle International Inc in 1997 (now INC Research), holding the position of vice president until 2004. In 2004, Dagmar Chase started up Clinrex, a consultancy firm for clinical research. Besides providing training, she focuses on Quality Management of clinical trials with a special focus on GCP gap analyses, inspection readiness, investigator initiated trials and working with CROs. She also manages the interface to DSMBs/DMCs. Dagmar Chase is a co-founder of the German CRO association BVMA, which was established in 1991. She is the president of the BVMA since 2001. In addition, she is a co-founder of EUCROF, the EU CRO Federation, which was established in 2005 and for which she held the position of vice-president over a period of 10 years. Philippe VAN DER HOFSTADT EU President, CSM (Belgium) Entrepreneur, service provider and advisor to the Biotech and Pharmaceutical Industry. Pioneer of cost-efficient, innovative and integrated Clinical Research ... Philippe VAN DER HOFSTADT Networker through Customers, Colleagues, Professional Associations and Conferences. Jerome Chiaro Vice-President, StudyKIK (USA) Jerome is Vice President of Clinical Site Operations at StudyKIK and regularly presents workshops for a non-profit, SCORE in Orange County, CA. Jerome Chiaro Jerome is Vice President of Clinical Site Operations at StudyKIK and regularly presents workshops for a non-profit, SCORE in Orange County, CA. Previous to the clinical trial industry, Jerome was a social media consultant for businesses across the US and he has published multiple e-books and video training series' on the topic of social media marketing. His professional passion is the use of Social Media as a new highly innovative and disruptive technology to clinical trials; the latest techniques for patient recruitment, retention and advocacy across the new and old platforms including: Snapchat, Instagram and Facebook. © Free Joomla! 3 Modules - by VinaGecko.com SEE ALL FEATURED SPEAKERS Venue/Accomodation Beautiful Joomla 3 Templates To Finish In Record Time! Beautiful Joomla 3 Templates To Finish In Record Time! 0 1 President Hotel address 12, Hospitalna street, Kyiv, 01023, Ukraine phone +38 (044) 256 - 3256, 256 – 3857 email info@presidenthotel.com.ua Web www.presidenthotel.com.ua The event will be held at President Hotel which is located in the downtown of Kyiv. It has a great territory and extensive service infrastructure. The hotel is situated 39 kilometres from international airport Borispol. It will take you 15 minutes walk to the main square of Kyiv – Maidan Nezalezhnosti. Accomodation is not included in the registration fee. The rooms at President Hotel are available at the discount rate of €100. Please mention the promo code “pharmasich conference” to obtain the discount making your reservation online or by phone. Alternative Accomodation Premier Hotel Rus Address: 4 Hospitalna St., Kyiv 01601, Ukraine Тel.: +38 (044) 256 40 00 Fax: +38 (044) 289 43 96 Viber: +38 044 256 40 20 Web: www.hotelrus.phnr.com Е-mail: info@hotelrus.kiev.ua Three-star Pemier Hotel Rus is located just 100 meters from the conference venue. It is large and comfortable but at the same time reasonably priced hotel offering the rooms from €60 per night. The reservation can be made online or by phone. Transportation/ Business Services Transfer from their airport can be requested at the hotel. The approximate cost is €25. The nearest “Palats Sportu” metro station is located near-by, just 8 minutes to walk. Computers, printers and copiers are available in the business centers of President Hotel and Premier Palace Rus. Transportation/Lodging Issues If you have a question or problem with your accommodation/accommodation the hotel cannot resolve or you have special needs, please contact us at phone +380504185120, emails smyronenko@pharmasich.com , info@pharmasich.com EVENT LOCATION President Hotel 12, Hospitalna street, Kyiv, 01023, Ukraine +38 (044) 256 - 3256, 256 – 3857 info@presidenthotel.com.ua Get Direction Get Direction Event Partners & Sponsors Event organiser Event patronage Pharmaceutical industry review Information partner Russia’s fastest CRO Globally Harmonized Lab Data Commitment to Excellence Dedicated Research Centre in Ukraine Clinical Trials Insurance www.clinerion.com Russia’s fastest CRO Patient travels solutions Clinical Research Middle East Global Reach Local Talent Easy EDC solution We excel for excellence Site management & research solutions Clinical trials in Poland Prev Next Become Become a sponsor EVENT SCHEDULE Dowload Download Schedule Day One 9th November, 2017 Day Two 10th November, 2017 Key note Day One ICH-GCP E6 (R2) Clinical Operations --- Risk Based Approaches in Clinical Trials Medical Affairs & Clinical Development --- Bioequivalence/Early Phases Studies THE END Regulatory Day Two Outsourcing in Clinical Trials Special Topics --- Regional Focus: Emerging Markets Medical Devices Trials - Organisers Organisers The Forum is organized by PharmaSich – the leading CRO in Eastern Europe headquartered in Kiev, Ukraine. PharmaSich was founded in 2012 by the group of Ukrainian pharma industry professionals to satisfy the clinical research needs of pharmaceutical and medical devices companies and to promote Ukraine internationally as a good place for R&D, manufacturing and marketing of pharmaceuticals and medical devices. PharmaSich has been representing Ukraine in the European CRO Federation (EUCROF) and in TEDDY - European Network of Excellence for Paediatric Clinical Research, an independent Research Network (category 1 network member of Enpr-EMA). Contacts: Sergii Myronenko, Chief Executive Officer Paris Komuna Str. 5, Kotsubynske, Kiev Region, 08298, Ukraine Email: info@pharmasich.com ; smyronenko@pharmasich.com Web: http://pharmasich.com Patronage The conference is held under the patronage of the European CRO Federation, EUCROF. Founded in 2005, EUCROF is the largest European non-profit CRO association. .. It aims at promoting clinical research and at supporting close relationship and exchange of information between member associations. The Federation develops training and educational programmes for clinical research and shares information on developments in clinical research with health care professionals at international level. EUCROF consists of members and associate members from 19 countries (Belgium, Czech Republic, France, Germany, Greece, Italy, Slovak Republic, Spain, Sweden, the Netherlands, Turkey, UK; Austria, Bulgaria, Denmark, Portugal, Serbia, Switzerland, Ukraine) and stands for over 320 member CROs and over 20.000 employees. Contacts: EUCROF Secretariat Assia Rosati- EUCROF - Via Bassano del Grappa, 4 - 00195 Rome (Italy) Email: info@eucrof.eu Web: www.eucrof.eu Organising Committee Chairman Sergii Myronenko, MD (Ukraine) Clinical Research Professional with strong medical background: board certified anesthesiologist; 4.5 years experience as an ICU physician. Left Readmore Right Chairman 13 years experience within the clinical research industry in various roles (QA, PM, Medical Reviewer, Start Up, Business Development). Dr.Myronenko is a key founder and CEO of PharmaSich CRO. Professional interests: clinical trials in Eastern Europe; models of the collaboration between niche CROs. Key Advisor of the Conference Dr. Martine Dehlinger-Kremer (Germany), EUCROF President Dr. Martine Dehlinger-Kremer is President of EUCROF, the European CRO Federation; Vice President, Global Medical and Regulatory Affairs at SynteractHCR Left Readmore Right Key Advisor of the Conference , a CRO with headquarters in California and 11 other offices internationally. She is also a Board member of EFGCP (European Forum for GCP). Dr. Dehlinger-Kremer has 30 years of experience in the clinical research industry, including more than 27 years of progressively higher levels of Regulatory and Medical Affairs leadership responsibility. Dr. Dehlinger-Kremer has contributed to the global development of numerous products, including orphan drugs and biosimilars. She has participated in more than 100 New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs) globally and in numerous clinical studies across all phases. Dr. Dehlinger-Kremer has served as Chair of the Paediatric Working Group of EUCROF since 2008 and has influenced the standards, protocols and number of trials conducted for drugs being administered to children. Dr. Dehlinger-Kremer is chair of the EFGCP Children Medicines Working Party. Dr. Dehlinger-Kremer is also Member of Working Parties of Enpr-EMA, the European Network of Paediatric Research at the European Medicines Agency. Dr Dehlinger-Kremer was Named One of PharmaVOICE 100’s Most Inspiring People in Life Sciences (Industry leader recognized for impact, experience and advocacy in clinical research) in August 2015. © Free Joomla! 3 Modules - by VinaGecko.com Sponsorship Opportunities Dear CROs and Clinical Trial Vendors, Sponsoring and taking part in the exhibition of the 1st Kiev Clinical Research Forum is an excellent opportunity to increase visibility of your organization. The following Sponsor packages are available: Silver Sponsor € 800 check Participant’s passes: 2 check Exhibition Booth Gold Sponsor € 1200 check Participant’s passes: 3 check Exhibition Booth check Logo, the link to the corporate website and the short description of the company’s specialty in conference promo materials check Printed leaflets included in the participant’s materials check Other Marketing Activities as required by Sponsor We invite you to become a Sponsor of the 1st Kiev Clinical Forum. Please send your requests to info@pharmasich.com or give a call at +380504185120 to discuss the sponsorship opportunities. Organisational Committee of 1st Kiev Clinical Research Forum. REGISTER Thank you for your interest in our conference. You need to complete online registration to attend. Your registration is not complete until we receive the payment. If you need to request your management for the conference attendance, you can customize Request to Attend Kiev Clinical Forum Form and send it to your manager. The completed registration means that you accept Terms & Conditions of Attendance. For assistance or questions, please contact us at email info@pharmasich.com , tel. +380504185120. The Early Bird Discount is still effective! Please register today and attend the conference just for €200. In order to promote the professional knowledge of clinical trials, young professionals (in the age of under 30) can attend the conference sessions free of charge. Please refer to Attendance by Young Professionals to find out how to apply Please complete all required fields! Invalid Input Invalid Input Invalid Input Invalid Input Invalid Input Invalid Input Choose your payment method Credit card Bank transfer Invalid Input Register Now HOT TOPIC Start up Planning of Multinational Studies. What are the benefits of having clinical sites in the CEE. Dr. Julian Platon (Switzerland) Dr. Julian V. Platon has been born in Bucharest, Romania in 1963. After his A Level in Bucharest he relocated to Germany in 1983 where he obtained the German Matura and studied Medicine in Cologne, London and Beer-Sheva. In parallel to his Conferral of Doctorate in Surgery he worked as a physician in the Department of Internal Medicine in Cologne, Germany. Since 1994 Dr. Platon had different national and international, operational and executive medical positions in the Pharmaceutical, Medical Devices and Clinical Research Organization industry in Germany, USA and Switzerland. A special focus was addressed to Medical Affairs, Clinical Development & Operations and Pharmacovigilance (incl. QPPV). Stations of his professional life were Schwarz Pharma, Hoffmann-La Roche, Abbott, PharmaPart, Solvay and Alexion. Since 2016 he is providing advice and operational services to biopharmaceutical and medical devices companies and CROs on international clinical development.harmaceuticals. Contact Us Please complete all required fields! Error Name Error Email Send Message Sergii Myronenko, MD Chairman of Kiev Clinical Research Forum a +380504185120 a smyronenko@pharmasich.com Dmytro Razborov, MD Member of Organising Committee of Kiev Clinical Research Forum a +38067 353 23 23 a drazborov@pharmasich.com Goto Top © 2017 KIEV CLINICAL RESEARCH FORUM . 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