Tuesday, November 28 th, 2017

Transcription

1 Sponsored by: New Clinical Trial Regulation, EU 536/2014 and national adoptions: challenge or opportunity? All you need to know on the changing face of clinical drug development in Europe Tuesday, November 28 th, 2017 Renaissance Paris La Defense Hotel 60, Jardin de Valmy, La Defense - Paris, France

2 New Clinical Trial Regulation, EU 536/2014 and national adoptions: challenge or opportunity? All you need to know on the changing face of clinical drug development in Europe The new Regulation, that will come into application during 2019, marks substantial and important changes in the processes, procedures and documentation necessary for management of clinical trials and relationships between Sponsors, Ethics Committees, Regulatory Agencies and Researchers. The aim of the new legislation is to streamline bureaucratic aspects through a simple and harmonized authorization process, involving a centralization of the procedures and consistent involvement of all Member States. What are the potential impacts for involved parties? The French e-pharma Day will examine implications of the new Regulation from different viewpoints with a special focus on the national adoption. Participants will gain an understanding of both fundamental and practical considerations impacting on drug development strategies, management of clinical trials as well as corporate governance related to implementation of the new Regulation. Speakers from regulatory Authorities, Ethics Committees, pharmaceutical industry and associations as well as representatives from CROs will be involved. The Scientific Board here below presented, will lead a panel of prestigious experts to share best practices, knowledge, and experience in this field: Anna Cali, Head of DCV Medical Affair, Sanofi Japan Erick Gaussens, Executive Advisor and Chief Scientific Officer, ProductLife Group Bertrand Sohier, Global Head, Respiratory, Critical Care, Cardiovascular and endocrinology Therapeutic Areas, PAREXEL Official Language: French Who should attend? Representatives of Pharmaceutical and Biotechnology companies, Clinical Research Organizations, Academic centers, Hospital Centers, and Clinical Technology companies. Especially Clinical Research Professionals, belonging to the following departments: Research & Development Clinical Operations Regulatory Quality Assurance Pharmacovigilance Statistics and Data Management Medical Affairs Information Technology

3 Agenda Official Language: French *Please note PPD and Allen & Overy LLP presentations will be in English 09:00-09:30 Registration and welcome coffee 09:30-09:40 Welcome from the Scientific board Anna Cali - Head of DCV Medical Affair at Sanofi Japan Erick Gaussens - Executive Advisor and Chief Scientific Officer at ProductLife Group Bertrand Sohier - Global Head, Respiratory, Critical Care, Cardiovascular and endocrinology Therapeutic Areas at PAREXEL 09:40-10:20 Emmanuel Prades - Director of Clinical Operations at VCLS EU 536/2014: impact on Regulatory Framework for Clinical Trial Applications within the European Union 10:20-11:00 Leona Fitzgerald - Senior Director Regulatory Affairs at PPD EU 536/2014, implications for submissions and start-up; consequences on the sponsor/cro relationship* 11:00-11:30 Coffee break 11:30-12:10 Marco de Morpurgo - Associate at Allen & Overy LLP Eveline Van Keymeulen - Counsel at Allen & Overy LLP EU 536/2014: how to prepare implementation?* 12:10-12:50 Marine Rubat du Merac - Senior lawyer at FIDAL law firm Clinical Research: the national legal perspective and consistency with EU 536/ :50-13:50 Networking lunch 13:50-14:30 Sylvie Hansel-Esteller - Consultant EU 536/2014: Impact on Research Ethical Committees / Comité de Protection des Personnes 14:30-15:10 Fatma Hindi - Country Project Manager at OPIS France Inspections with the new EU 536/2014: Prepare for the unexpected! 15:10-15:40 Coffee break 15:40-16:20 Jacques Demotes - MD, PhD, Director General at ECRIN Implementing the EU Clinical Trials Regulation - an Academia Perspective 16:20-17:00 Patrick Maury - Regulatory Affairs / Head Clinical Trial Coordination at Sanofi How are companies working to be ready? Will there be an impact on the companies organization? - Sanofi view 17:00-17:20 Conclusive panel discussion - EU 536/2014: hell, heaven or purgatory? Marco de Morpurgo - Associate at Allen & Overy LLP Leona Fitzgerald - Senior Director Regulatory Affairs at PPD Sylvie Hansel-Esteller - Consultant Fatma Hindi - Country Project Manager at OPIS France Emmanuel Prades - Director of Clinical Operations at VCLS Marine Rubat du Merac - Senior lawyer at FIDAL law firm Eveline Van Keymeulen - Counsel at Allen & Overy LLP 17:20-17:30 Conclusions

4 How to reach the conference venue Venue Renaissance Paris La Defense Hotel - 60, Jardin de Valmy, La Defense - Paris, France Renaissance Paris La Defense Hotel is situated in the heart of the La Défense business district, just 400 m from La Défense Metro and RER Train Station. Public Transportation Subway station: Metro line 1 - La Defense Grande Arche, EXIT B Left Tramway 2 - direct to Porte de Versailles Bus station: La Defense Grande Arche Train Station: Gare du Nord (Eurostar Connection) RER A - La Defense Grande Arche, EXIT B Left From the Airport From Charles de Gaulle Airport - 25 km: Bus service, fee: 15.6 EUR (one way), Subway service, fee: 10.2 EUR (one way) Estimated taxi fare: 50 EUR (one way), Navigation: if using a GPS to drive to the hotel, please use the following coordinates: Rue Jules Ferry, Puteaux, longitude latitude From Orly Airport - 21 km: Bus service, fee: EUR (one way), Subway service, fee: 13.5 EUR (one way) Estimated taxi fare: 35 EUR (one way), Navigation: if using a GPS to drive to the hotel, please use the following coordinates: Rue Jules Ferry, Puteaux, longitude latitude For further information please visit the conference website or contact the organization offices: Ilaria Butta Phone: +39 (0) Mail: ilaria.butta@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

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 10th November ,00 Ordinary fee (after 10th November 2017) 540,00 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: Ilaria Butta ilaria.butta@lsacademy.it Phone +39(0) 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.