Wednesday, May 31 st, Implementation of Clinical Trial Regulation EU 536/2014 and National adoption. Copenhagen, Denmark

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1 Sponsored by: Implementation of Clinical Trial Regulation EU 536/2014 and National adoption Wednesday, May 31 st, 2017 Copenhagen, Denmark Park Inn by Radisson Copenhagen Airport Hotel Engvej Copenhagen

2 Implementation of Clinical Trial Regulation EU 536/2014 and National adoption All professionals involved in the clinical research process are focusing their attention on the forthcoming entry into force of the new European Regulation 536/2014 on clinical trials on medicinal products for human use, scheduled for October The new regulation demand substantial and important changes in the methods for conducting clinical trials and in the relationships between Sponsors, Ethics Committees, Regulatory Agencies and Researchers. The Regulation 536/2014 (Clinical Trial Regulation) is more than an incremental advance on the previous legislation. This is a major revision that will take considerable adjustment in both clinical operations and in the supporting structures. The aim of the new legislation is to streamline the bureaucratic aspects, through a simple authorization process, which provides a centralized procedure with a consistent approach in all Member States. The administrative management of clinical studies should also be easier through the use of a new EU portal. Other important new features include low level intervention clinical trials; compensation for damage (with a proportionate approach to risk); the concept of co-sponsorship; new guidance on informed consent; eligibility of the experimental sites; guidance on trials in vulnerable populations and in emergency situations; new opportunities for more transparency and dissemination of information on clinical trials; the role of ECs; the certification for independent research and risk based monitoring. Janet Fernihough, PhD MBA, Senior Consultant at Navitas Life Sciences, and Christina Songhurst, Director of Project Management at PPD, scientific board of the event, will lead a panel of experts in order to share best practices, knowledge and experience in this field. Who should attend? The conference is aimed at all Clinical Research Professionals, belonging to the following departments: Research & Development Clinical Operations Regulatory Quality Assurance Pharmacovigilance Statistics and Data Management Medical Affairs Information Technology from Pharmaceutical and Biotechnology companies, Clinical Research Organizations, Academic Centers, Hospital Centers, and Clinical Technology companies.

3 Implementation of Clinical Trial Regulation EU 536/2014 and National adoption 09:00-09:30 Registration and Welcome Coffee 09:30-09:50 Welcome from the Chair Janet Fernihough - PhD MBA, Senior Consultant at Navitas Life Sciences Christina Songhurst - Director, Project Management General Medicine - Immunology at PPD 09:50-10:50 Karen Kiilerich - Special Legal Consultant at The Danish Council on Ethics and National Committee on Health Research Ethics Lene Grejs Petersen - M.Sc.Pharm, Senior Adviser at Danish Medicines Agency, Medicines Licensing & Availability, Clinical Trials Danish regulations and considerations toward the Implementation of the Clinical Trial Regulation 10:50-11:20 Coffee break 11:20-12:00 Ingvild Aaløkken - Head of Unit, section for preclinical assessment and clinical trials - Department for Medicinal Product Assessment at Norwegian Medicines Agency Implementation of the Clinical Trial Regulation in Norway 12:00-12:40 Gunilla Andrew-Nielsen - Head of Department of Clinical Trials and Special Permissions at Medical Products Agency (MPA) Swedish Clinical Trial Regulation implementation status 12:40-13:20 Niels Buch Leander - Managing Consultant, Ph.D. - Global Regulatory Affairs Lead Life Sciences at NNIT Gitte Holm Rove - Advanced Consultant at NNIT Ensuring a swift and timely transition to compliance with Clinical Trial Regulation 13:20-14:20 Networking Lunch 14:20-15:00 Leona Fitzgerald - Senior Director Regulatory Affairs at PPD Clinical Trial Regulation EU 536/2014, implications for submissions and start-up. Evolution of the sponsor/cro relationship 15:00-15:40 Janet Fernihough - PhD MBA, Senior Consultant at Navitas Life Sciences Risk based approach to clinical trial management 15:40-16:10 Coffee break 16:10-16:50 Timo Minssen - Professor of Life Science Law at University of Copenhagen Legal clashes between the Transparency provisions in Regulation 536/2014 and the new EU rules on Trade Secrets & Data Protection 16:50-17:10 Panel Discussion 17:10-17:15 Conclusions

4 How to reach the conference venue Venue Park Inn by Radisson Copenhagen Airport Hotel Engvej Copenhagen, Denmark Situated near both the Copenhagen Airport and the city centre, the Park Inn is an ideal place to stay while traveling for business and leisure. If you arrive by car, this hotel s location in Copenhagen, Denmark provides free parking. The nearby metro and train stations are convenient for cyclists and guests without cars. Transport options Metro station Femøren (two stops to airport and six to city centre) - beside hotel Copenhagen International Airport - 3 km (5 min by metro) Copenhagen Central Station - 7 km (10-15 min by car) For further information please visit the conference website or contact the organization offices: Stefania Sarga Phone. +39 (0) stefania.sarga@lsacademy.it Sponsorship opportunities Sponsor the event and take the chance to network with all attendees. Exclusive benefits and high impact branding before, during and after the conference. If you are interested in sponsoring the event, please write an to events@lsacademy.it or call us: +39(0) Download the Events Summary 2017

5 TWO WAYS TO REGISTER: Online: please register here In this case, you can choose to pay by credit card or by bank transfer. By or fax: please fill the registration form below for each attendee and send it by or by fax: +39(0) In this case, you can pay by bank transfer. 595,00 Early Bird fee extended until May 11th, ,00 Ordinary fee (after May 11th, 2017) 590,00 Patronage members fee (Association ) 390,00 for Academy, Public Administration, Freelance (please, specify ) Payment by bank transfer The full amount must be paid on registration to EasyB S.r.l by bank transfer. If you pay by bank transfer, please attach proof of payment to the registration form. Bank transfer payable to: The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, welcome coffee, networking lunch, coffee break, organisational office assistance, certificate of attendance. For any additional information, please contact: Stefania Sarga stefania.sarga@lsacademy.it Phone +39 (0) Fax: EasyB S.r.l. Via Roma, Alzano Lombardo (Bergamo) VAT: IT Banco Popolare Società Cooperativa Filiale di Carobbio degli Angeli IBAN: IT81 F SWIFT Code: BAPPIT21AY5 Surname Company Name Job title Address City Phone Post code Fax. Special Dietary Requests INVOICING DETAILS Company name Address Mail address (If different) Post code City VAT number Date Signature Terms of payment The registration fee must be paid at the time of registration. Confermation of event 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 or registrations of roles that are not included in the target of the event. 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 event date. Cancellations will only be valid if made in writing (by ). 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. Information collection and use Participants information is collected and utilised by EasyB S.r.l. and sponsor companies in accordance with Italian Legislative Decree 196/2003. Data collected will be used and communicated to third parties for the purposes of event organisation and may be used to communicate future similar initiatives. Participants may at any time verify the accuracy of the information and request changes or deletion. During the event, the LS Academy Staff may take pictures, that could be shared on our Social Media pages.