London, United Kingdom

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1 Sponsored by: UK Pharmacovigilance Day London, United Kingdom Tuesday, June 6th, 2017 Park Plaza Victoria London 239 Vauxhall Bridge Road - London

2 UK Pharmacovigilance Day The vote to leave the EU on 23rd June 2016 resulted in BREXIT becoming a major topic for pharmacovigilance in the UK. The political alignment of the MHRA and its future within the GVP framework remain somewhat of a mystery to UK PV professionals. We hope to shed some light in this area during our Hot Topics in Pharmacovigilance Day A number of key areas of interest will also be covered, including the impact of social media, drug-device vigilance and patient support programs. This year is expected to be an interesting one for professionals dealing with the drug safety, biologics and medical devices. With increasing regulatory expectations and innovative initiatives in place, the pharmacovigilance space in the EU is being watched by the whole world, more specifically the UK and its relationship with the EMA. At such a time, it becomes imperative to collate the thoughts of all stakeholders of pharmacovigilance on the same platform. As ever, the offering of the UK Pharmacovigilance Day 2017 conference looks forward to accomplishing this with a great deal of consideration and commitment to ensure your time spent with us adds value. The conference, invites you to hear expert speakers from the industry, regulatory agencies, research bodies, academia and healthcare delivery centres who will take you through the latest Hot Topics In in the discipline and deliberate on the challenges they face. Join us for an intriguing insight into the UK pharmacovigilance arena. Hear from the experts, share best practice and use this opportunity to network with fellow professionals within the pharmacovigilance sector. Chair: Dr J Vijay Venkatraman, Managing Director & CEO at Oviya MedSafe Co-Chair: Shirley-Ann van der Spuy, Managing Director & EU QPPV at Red Line Pharmacovigilance Offiicial language: English Who should attend? The seminar is ideally suited for employees of small-, middle- and large-sized companies in the pharmaceutical sector especially concerned with the implementation and/or maintenance of Pharmacovigilance/Vigilance Systems, with its critical processes and quality system. Participants may come from various departments involved in fulfilling Pharmacovigilance/Vigilance requirements as legal Medical Affairs and Regulatory Affairs.

3 UK Pharmacovigilance Day Agenda 09:00-09:30 Registration and welcome coffee 09:30-09:40 Welcome from the Scientific board 09:40-10:20 Phil Tregunno - Signal Management Unit Manager, and IMI WEB-RADR project lead at MHRA Mobile Technologies and Social Media in Pharmacovigilance a view from the WEB-RADR project 10:20-11:00 John Barber - Qualified Person for Pharmacovigilance and Director, Head of Pharmacovigilance, European Operations at Dr. Reddy's Laboratories UK Brexit is Brexit, but what about pharmacovigilance? 11:00-11:30 Coffee break 11:30-12:10 Michael Ramcharan - Managing Director at Reumat Consulting Ltd Inspection KPI MHRA Expectations 12:10-12:50 Shirley-Ann van der Spuy - Managing Director & EU QPPV at Red Line Pharmacovigilance PV Challenges for the SME 12:50-13:50 Networking lunch 13:50-14:30 Vivek Ahuja - Vice President, Global Pharmacovigilance at ArisGlobal Software Pvt. Limited Automation in Pharmacovigilance Data Processing do you trust Artificial Intelligence? 14:30-15:10 Daniela Di Cosmo - Pharmacovigilance Scientist at Aspen Pharma Trading Limited Patient view: the influence of real-time patient ratings and reviews of medicines and healthcare, and how this will shape the future of pharmacovigilance 15:10-15:40 Coffee break 15:40-16:20 Dr J Vijay Venkatraman - Managing Director & CEO at Oviya MedSafe Pharmacovigilance as a Value Addition to the Global Pharmaceutical Industry 16:20-16:50 Emilio Vandelli - Director at Arithmos Pharmacovigilance and enabling technologies: which business model in a fast changing world? 16:50-17:00 Conclusions

4 How to reach the conference venue Venue Park Plaza Victoria London Vauxhall Bridge Road - London, United Kingdom The Park Plaza Victoria London is centrally located just two minutes from Victoria Station, Gatwick Express and the National Rail station, with direct services to central London, Gatwick Airport and the South of England. Getting to Park Plaza Victoria London by Public Transport From London Heathrow Airport (approx 60 mins)* Take the London Underground, Travel Eastbound on the Piccadilly Line, Change at Hammersmith, Take the District Line to Victoria Station, Walk south on Wilton Road for 100 metres. Park Plaza Victoria London will be on your left From London Gatwick Airport (approx 35 mins)* Take the Gatwick Express train to London Victoria Station, Take exit by Platform 2, Turn right and continue to walk 100 metres. Park Plaza Victoria London will be on your left From London Stanstead Airport (approx 90 mins)* Take Stansted Express to Liverpool Street National Railway station, Change to London Underground and take the Circle Line to Victoria Station, Walk south on Wilton Road for 100 metres. Park Plaza Victoria London will be on your left From King s Cross & St. Pancras National Railway Station (approx 15 mins)* Take the London Underground, Take the Victoria Line southbound towards Brixton, Depart at Victoria, Walk south on Wilton Road for 100 metres. Park Plaza Victoria London will be on your left *Please note these are just sample travel directions. For travel directions from other locations to in London or alternative travel options please visit tfl.gov.uk. 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. 665,00 Early Bird fee until 6th May ,00 Ordinary fee (after 6th May 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: 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.