Real World Data Generation: Methods, Strategy & Design

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1 A two-day intensive course to explore the methodological and technical connections between RWD and observational methods and to learn the most critical and successful factors for designing researches to generate Real World Evidence. 210 Early Bird discount for enrolment by 06 th November 2018 [NEW FORMAT] Course Language: English Copenhagen Marriott Hotel Kalvebod Brygge 5, 1560, Copenhagen V, Denmark Tuesday 27 and Wednesday 28 November :00-17:30 Taking part in our training courses, Michela Rimondini e Monia Dardi Il Vaso di Fiori you support "The Vase of Flowers" project For additional information: +39 (0)

2 Introduction Nowadays, Real World Data (RWD) is a fundamental tool for the development & value s demonstration of new health technologies, through the evaluation of what happens in actual clinical practice. Methods to generate Real World Evidence by means of RWD are extremely heterogeneous since they include many different types of study design, study typologies and data sources. However, all types of RWD collections, with the only exception of the Pragmatic Trials, share the same common methodology: the observational method. As a consequence, in order to design and successfully execute a RWD collection, it is essential to handle the principles of epidemiology and outcome research and to have a very good knowledge of observational methods. Moreover, since this type of research activity is only partially regulated, both at local and international level, it is also required a basic knowledge of certain legal constraints. Finally, from an operational point of view, it is important to be aware that the use of the traditional operative models borrowed from classical clinical studies is not the right solution. The aim of this two-day intensive course is to explore the methodological and technical connections between RWD and observational methods and to share the most critical and successful factors for designing researches to generate Real World Evidence. Using very interactive methods, including some class exercises, the participants will learn how to successfully conduct a RWD collection, starting from the definition of a well-defined research question, followed by the design of a research model which will focus on the product s business strategy, legal & ethical constraints and the methodological standards. Who should attend? The course is aimed at everyone who works in Life Science industry, such as pharmaceutical, medical devices companies and biotech, and needs to design and/or execute a Real World Data collection based on observational methods aimed to define or secure the product value in a pre and/or post marketing phase of the product life cycle. Attendees experience Experience in Medical Affairs and/or Clinical Development. Specialists from Clinical Operations, Market Access, Health Economics and Outcome Research (HEOR) are also welcomed.

3 Teaching methods Interactive lessons with case studies and classroom exercises. Course subjects: 27 November: Definitions, applications and regulations Course language: English Real World Data (RWD) and the need of Real World Evidence Methodological background of RWD and Outcome Research (OR): the observational methods RWD/OR in Pre Marketing phase (burden of disease, epidemiology, patients journey, etc.) RWD/OR in Post Marketing phase (PASS/PAES, DUS, CER, etc.) Regulations and international standards impacting RWD/OR using observational methods Course subjects: 28 November: How to design a study? Strategic approaches to Real World Data How to define the "Research Question" Advantages and Disadvantages of the main Study Designs How to deal with Confounders Communication of the results Agenda Day 1 Day 2 9:00-9:30 Participants registration 9:00 Course commences 9:30 Course commences 11:00-11:15 11:00-11:15 12:30-13:30 Lunch 12:45-13:45 Lunch 15:30-15:45 15:30-15:45 17:00 Q&A and Conclusion 17:30 End of day 1

4 At the end of the training, you will be able to:...identify the key successful factors that characterize the design of a real world data collection based on observational methods. Lecturer's Bio Simona Sgarbi - Senior Real World Evidence Lead Lundbeck Simona holds a MS in Biophysics. Since 2002 (when she joined Medineos-an IQ- VIA company), she has been working in Real World Evidence research focusing on methodology and laws/regulations within the pharmaceutical and medical device fields. This has involved the project management of complex multinational peri- and post-approval studies. She is highly skilled in connecting the product development strategy with the design of observational studies (including prospective and retrospective cohort studies, case control, cross sectional) and various typology (such as epidemiological studies, patient registries, PASS/PAES, MCR, etc.). She has authored several scientific publications in peer-reviewed scientific journals and presented lectures for both national and international congresses. She is an active member of international scientific associations, including ISPOR (International Society of Pharmaco-economics and Outcomes Research). Recently, she has joined Lundbeck as Senior RWE Lead within the HEOR & RWE Medical Affairs Department, based in Copenhagen.

5 TO REGISTER FOR THE COURSE YOU CAN FILL IN AND SEND THE REGISTRATION FORM OR DIRECTLY REGISTER ONLINE: REGISTRATION FEES: Methods of payment Early bird: 1570,00 until 06/11/2018 Ordinary: 1780,00 Freelance Academy Public Administration: 890,00 The full amount must be paid on registration to EasyB s.r.l by bank transfer or by credit card. If paying by bank transfer please attach proof of payment to the registration form. Bank transfer payable to: EasyB S.r.l. Via Roma, Alzano Lombardo (BG) The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. P. IVA Banco BPM - Filiale di Carobbio Degli Angeli IBAN: IT81 F SWIFT CODE: BAPPIT21AY5 For additional information: Secretarial office Phone Fax Mail LS Academy +39 (0) Please fill in and send: (+39) Surname Company Address City Tel. Special Dietary Requests Invoicing details Company name Address Mail address (If different) City VAT number Terms & conditions Name Job title Post code Fax. Post code or register online. Terms of payment The registration fee must be paid at the time of registration. Confirmation of course admission will be given on receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants. Cancellation Please note that refunds (70% refund of the registration fee) will only be given if cancellation is received at least one week before the course date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, or hostilities. LS Academy reserves the right not to accept registrations not compatible with the event s target audience. The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course. In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT ) will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for sending newsletters, for marketing purposes (sending advertising material, market research and commercial communication) and for communication purposes to third parties (lecturers), also for marketing goals. You can read the complete information, including your rights and the procedures for the exercise of the same, following this link. LSACADEMY.com Date Signature