PHARMACOVIGILANCE: FUTURE CHALLENGES AND OPPORTUNITIES

Transcription

1 French Pharmacovigilance Day Tuesday, November 20th, 2018 FUTURE CHALLENGES AND OPPORTUNITIES Paris, France Hilton Paris La Défense 2 Place de la Défense - Paris Sponsored by: Michela Rimondini e Monia Dardi Il Vaso di Fiori Taking part in the event, you support The Vase of Flowers project

2 French Pharmacovigilance Day FUTURE CHALLENGES AND OPPORTUNITIES ABOUT For the fourth consecutive year, Life Science Academy is organising a French Pharmacovigilance Day to be held in Paris on 20 November The day represents an opportunity to share experiences while presenting different points of view with experts in the life sciences field, coming from industries of different sizes; with health authority representatives; and with members of contract research organisations. The academy will provide participants with insights into the ever-growing complexities and challenges affecting safety and risk management. French Pharmacovigilance Day will also enable open discussion in interactive sessions, with a focus on recent changes in good pharmacovigilance practices that companies face in dealing with new artificial intelligence tools, combination drug medical devices, and the safety surveillance of complex clinical trials. In addition, the day will cover the impact of Brexit as well as the impact of enforcement of recently released Regulations (ie, the Clinical Trial Regulation, the Medical Device Regulation and the General Data Protection Regulation) on pharmacovigilance activities which enforcements are expected shortly. After the outstanding success of French Pharmacovigilance Day in 2017, which brought together professionals from France and the rest of Europe, it is indeed a pleasure to welcome everyone to 2018 s French Pharmacovigilance Day an opportunity for networking together with knowledge and experience sharing during this one Scientific Board Amir Lahouegue Head of Patient Safety, Medical Information & Neuroscience Therapeutic Area Medical Affairs at AstraZeneca Erick Gaussens Executive Advisor and Chief Scientific Officer at ProductLife Group Solange Rohou Sr. Director Regulatory Affairs & Policy, Europe at AstraZeneca 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 AGENDA French Pharmacovigilance Day FUTURE CHALLENGES AND OPPORTUNITIES 09:00-09:30 Registration and welcome coffee 09:30-09:40 Welcome from the Scientific Board Amir Lahouegue - Head of Patient Safety, Medical Information & Neuroscience Therapeutic Area Medical Affairs at AstraZeneca Erick Gaussens - Executive Advisor and Chief Scientific Officer at ProductLife Group Solange Rohou - Sr. Director Regulatory Affairs & Policy, Europe at AstraZeneca 09:40-10:10 Pharmacovigilance inspections: what are key regulators expectations? Virginie Bacquet - Regulatory Affairs and PhV Consultant 10:10-10:40 Pharmacovigilance Inspections An Industry view on readiness activities based on latest inspections findings trends and practical experience Sandrine Valiere - Global PV Audit/Inspection Readiness Head at Sanofi 10:40-10:50 Q&A Session 10:50-11:20 Coffee break 11:20-11:50 Brexit an MHRA perspective Phil Tregunno - Vigilance, Intelligence and Research Group Manager at MHRA The presentation will be in English 11:50-12:30 Key challenges and opportunities for pharmacovigilance with impact at local and global level for pharmaceutical industry Catherine Penfornis - Responsable Pharmacovigilance at Sanofi Amélie Prieur - Deputy QPPV at Sanofi 12:30-12:40 Q&A Session 12:40-13:40 Networking lunch 13:40-14:20 Pharmacovigilance in Low To Middle Income Countries: Inspiration, Challenge and Unity Jabeen Ahmad - Regional Pharmacovigilance Director, Eastern Europe, Middle East & Africa (EEMEA) at AbbVie 14:20-15:00 Do we really need AI? Regulators and Industry: the two sides of the issue Marco Anelli - Head of Medical Affairs and Pharmacovigilance Advisory Practice PLG (Product Life Group) Phil Tregunno - Vigilance, Intelligence and Research Group Manager at MHRA The presentation will be in English 15:00-15:10 Q&A Session 15:10-15:40 Coffee break 15:40-16:20 Regulation and Assessment of medical devices combined with medicinal products that they administer Yves Tillet - Director at WHITE-TILLET Consultants & Experts 16:20-16:50 French Local Literature Management for Pharmacovigilance Maxime Bittoun - Senior Sales Solution Manager at Elsevier 16:50-17:00 Q&A Session and Conclusion

4 HOW TO REACH THE CONFERENCE VENUE Hilton Paris La Défense 2 Place de la Défense - Paris Hilton Paris La Défense is located in Paris La Defense, and is the perfect base to explore Paris - Arc de Triomphe and Champs-Elysees are only a stop away by direct train. PEDESTRIAN ACCESS / PUBLIC TRANSPORTS Station stop La Défense Grande Arche by using: 1) Metro: Line N 1 2) RER: RER A 3) Tramway: T2 4) Train SNCF: From Saint-Lazare, Saint-Nom-la-Bretèche, Versailles-RD, Saint- Quentin-en-Yvelines or La Verrière 5) Buses: from Paris (N 73), from West Paris (141, 144, 159, 258, 262, 272, 275, 278, 360, 378) or from the North (161,174,178) CAR ACCESS From Charles de Gaulle Airport: Distance from Hotel: 35 km Drive Time: 40 min. From Paris Orly Airport Distance from Hotel: 43 km Drive Time: 40 min. 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. Download the Events Summary 2018 For further information Please visit the conference website or contact the organisational offices: Ilaria Butta Phone +39 (0) ilaria.butta@lsacademy.com

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 o fax please fill the registration form below for each attendee and send it by ilaria.butta@lsacademy.com or by fax : +39(0) In this case, you can pay by bank transfer. 655,00 Early Bird fee extended until November 9th, ,00 Ordinary fee (after November 9th, 2018) 570,00 Patronage members fee (Association ) 430,00 Academy, Public Administration, Freelance (please, specify ) 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. 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, Alzano Lombardo (Bergamo) VAT: IT BANCO BMP Filiale di Carobbio degli Angeli IBAN: IT81 F SWIFT Code: BAPPIT21AY5 For any additional information, please contact: Ilaria Butta ilaria.butta@lsacademy.com Phone: +39 (0) Surname Company Name Job title Address City Phone Post code Fax. Special Dietary Requests I wish that my data (name, surname, job position and company) are inserted in the list of attendees distributed the day of the event Yes No Invoicing details Company name Address Mail address (If different) Post code City VAT number Terms & Conditions Terms of payment The registration fee must be paid at the time of registration. Confirmation 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 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 (companies that sponsor the event, scientific board, speakers), 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. Date Signature