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Event Managed by
Renaissance Paris La Defense Hotel
Tuesday, November 28th, 2017
Sponsored by:
60, Jardin de Valmy, La Defense - Paris, France
New Clinical Trial Regulation, EU 536/2014and national adoptions: challenge or opportunity?All you need to know on the changing face of clinical drug development in Europe
Event Managed bywww.epharmaday.org
Who should attend?
All you need to know on the changing face of clinical drug development in Europe
Official Language: French
New Clinical Trial Regulation, EU 536/2014 and national adoptions: challenge or opportunity?
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 deve-lopment 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 repre-sentatives 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
Representatives of Pharmaceutical and Biotechnology companies, Clinical Research Organizations, Academic cen-ters, 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
Agenda
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*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 536/2014
12:50 - 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
Official Language: French
www.epharmaday.org Event Managed by
How to reach the conference venue
Ilaria Butta Phone: +39 (0)35.4123594 Mail: [email protected]
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.
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 email to [email protected] or call us: +39(0)35.515684
Download the Events Summary 2017
For further information please visit the conference website or contact the organization offices:
Venue Renaissance Paris La Defense Hotel - 60, Jardin de Valmy, La Defense - Paris, France
From Orly Airport - 21 km: Bus service, fee: 10.25 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 2.234057 - latitude 48.892591
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 2.234057 - latitude 48.892591
Terms of paymentThe 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 email).
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.
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TWO WAYS TO REGISTER:
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Online: please register here https://frenchepharmaday2017.eventify.it/orders/newIn this case, you can choose to pay by credit card or by bank transfer.
By email or fax: please fill the registration form below for each attendee and send it by email:
[email protected] or by fax: +39(0)35.4501262 In this case, you can pay by bank transfer.
€ 595,00 Early Bird fee extended until 10th November 2017
€ 710,00 Ordinary fee (after 10th November 2017)
€ 540,00 Patronage members fee (Association )
€ 390,00 for Academy, Public Administration, Freelance (please, specify )
The fee includes: seat at the conference, copy of presentations of Speakers who allow the di-stribution, 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
Phone +39(0)35.4123594
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:
EasyB S.r.l.
Via Roma, 20 - 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
Banco Popolare Società Cooperativa – Filiale di
Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT Code: BAPPIT21AY5
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