Renaissance Paris La Defense Hotel. French Pharmacovigilance Day. Pharmacovigilance at Horizon Monday, November 27th, 2017.

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1 Sponsored by: French Pharmacovigilance Day Renaissance Paris La Defense Hotel Monday, November 27th, , Jardin de Valmy, La Defense Paris, France

2 French Pharmacovigilance Day For the third consecutive year, we will organise the French Pharmacovigilance Day to reflect on hot topics with PV specialists and explore what could be foreseen at Horizon Patients involvement in Pharmacovigilance, impact of Brexit, signal detection and medication errors are some of the topics among others, currently under consideration by the organising committee. Interactions will provide attendees with regulatory references and best practices to meet regulator s standards and expectations. Experience from last year meeting and attendees feedback will be taken into consideration to make of this third French Pharmacovigilance Day a successful and useful meeting. The Scientific board: Françoise de Crémiers, Founder and President at FdC Consulting Solange Rohou, Senior Director at AstraZeneca will lead a panel of experts to share best practices, knowledge and experience in this field. Official language: French Who should attend? This one-day conference is designed to benefit functional/technical professionals working in the pharmaceutical and health care system dealing with the Pharmacovigilance system, such as: Pharmacovigilance dept. Clinical operation dept. Statistic dept. Medical Affairs dept. Regulatory Affairs dept. Quality & Compliance dept. in pharmaceutical and Biotech companies, Clinical Research Organizations (CROs) and publich health centers

3 French Pharmacovigilance Day Agenda Official language: French *Please note MHRA presentations will be in English 08:30-09:00 Registration and welcome coffee 09:00-09:15 Françoise de Crémiers - Founder and President at FdC Consulting Welcoming remarks - General introduction & aim of the day SESSION 1 - Setting the scene Chair: Françoise de Crémiers - Founder and President at FdC Consulting 09:15-09:45 Véronique Lamarque-Garnier - President at Éval'Santé Keynote: time to evaluate the real impact of the Pharmaceutical Legislation and improve quality of data and processes 09:45-10:00 Q&A session 10:00-10:30 Coffee break SESSION 2 PV practical aspects Chair: Anne Castot Villepelet - Pharmacologist and Specialised in public health PV practical aspects 10:30-11:00 Evelyne Pierron - Consultant Pharmacovigilance Senior and Owner at Evelyne Pierron Consultants Practical aspects in implementing the updated GVPs (revised Module V) 11:00-11:40 Amir Lahouegue - Head of Patient Safety, Medical Information & Neuroscience Therapeutic Area Medical Affairs at AstraZeneca French specificities - What s new? Including materiovigilance. Specific issues and how to overcome them with practical examples. 11:40-12:00 Phil Tregunno - Signal Management Unit Manager, and IMI WEB-RADR project lead at MHRA Signal detection - Impact on the PV system: the agency s perspective* 12:00-12:10 Q&A session 12:10-13:10 Networking lunch SESSION 3 Impact of Brexit on EU PV Chair: Solange Rohou - Senior Director at AstraZeneca 13:10-13:35 Phil Tregunno - Signal Management Unit Manager, and IMI WEB-RADR project lead at MHRA BREXIT the agency s view point* 13:35-14:00 Martine Jager-Morali - Director Drug Safety at Celgene France Impact of Brexit on Pharmacovigilance: a company view point 14:00-14:10 Q&A session SESSION 4 Practical aspects Chair: Véronique Lamarque-Garnier - President at Éval Santé 14:10-14:40 Diane Farkas - Pharmacovigilance Senior medical Advisor at Sanofi Medication error: the guideline implementation from the MAH perspective 14:40-15:10 Francois Meyer - Advisor to the President, International Affairs at HAUTE AUTORITE DE SANTE PASS/PAES & Registries - where are we? 15:10-15:25 Q&A session 15:25-15:55 Coffee break SESSION 5 Patient Engagement in PV Chair: Solange Rohou - Senior Director at AstraZeneca and François Houÿez - Treatment Information and Access Director / Health Policy Advisor at European Organisation for Rare Diseases (Eurordis) 15:55-16:15 Solange Rohou - Senior Director at AstraZeneca Setting the scene 16:15-16:45 François Houÿez - Treatment Information and Access Director / Health Policy Advisor at European Organisation for Rare Diseases (Eurordis) Patients involved in Pharmacovigilance, from reporting to the decision-making and communication 16:45-17:00 Q&A session and Concluding remarks

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 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 10th November ,00 Ordinary fee (after 10th November) 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.