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www.pharmacovigilanceday.com

UK Pharmacovigilance DayHot Topics in Pharmacovigilance 2017

London, United KingdomTuesday, June 6th, 2017

Sponsored by:

Park Plaza Victoria London 239 Vauxhall Bridge Road - London

Event Managed bywww.pharmacovigilanceday.com

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 2017. 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.

Who should attend?

Offiicial language: English

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 require-ments as legal Medical Affairs and Regulatory Affairs.

UK Pharmacovigilance Day

Hot Topics in Pharmacovigilance 2017

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

Agenda

Event Managed bywww.pharmacovigilanceday.com

UK Pharmacovigilance Day

Hot Topics in Pharmacovigilance 2017

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

Venue

How to reach the conference venue

Event Managed bywww.pharmacovigilanceday.com

Ilaria Butta Phone: +39 (0)35.4123594 Mail: ilaria.butta@LSacademy.it

Park Plaza Victoria London - 239 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.

*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.

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 events@LSacademy.it or call us: +39(0)35.515684

Download the Events Summary 2017

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 Vic-

toria 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

For further information please visit the conference website or contact the organization offices:

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://ukpharmacovigilanceday2017.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:

ilaria.butta@LSacademy.it or by fax: +39(0)35.4501262 In this case, you can pay by bank transfer.

€ 665,00 Early Bird fee until 6th May 2017

€ 756,00 Ordinary fee (after 6th May 2017)

€ 590,00 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

ilaria.butta@LSacademy.it

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)

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