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Event Managed by www.pharmacovigilanceday.com Renaissance Paris La Defense Hotel Monday, November 27th, 2017 60, Jardin de Valmy, La Defense Paris, France French Pharmacovigilance Day Pharmacovigilance at Horizon 2020 Sponsored by:

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Page 1: French Pharmacovigilance Dayeasy-b.it/documents/Brochure_French PV Day_2017.pdf · French Pharmacovigilance Day Pharmacovigilance at Horizon 2020 Sponsored by: Event Managed by For

Event Managed by

www.pharmacovigilanceday.com

Renaissance Paris La Defense HotelMonday, November 27th, 2017

60, Jardin de Valmy, La Defense

Paris, France

French Pharmacovigilance DayPharmacovigilance at Horizon 2020

Sponsored by:

Page 2: French Pharmacovigilance Dayeasy-b.it/documents/Brochure_French PV Day_2017.pdf · French Pharmacovigilance Day Pharmacovigilance at Horizon 2020 Sponsored by: Event Managed by For

Event Managed bywww.pharmacovigilanceday.com

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 2020.

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.

Who should attend?

Official language: French

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

French Pharmacovigilance Day

Pharmacovigilance at Horizon 2020

Page 3: French Pharmacovigilance Dayeasy-b.it/documents/Brochure_French PV Day_2017.pdf · French Pharmacovigilance Day Pharmacovigilance at Horizon 2020 Sponsored by: Event Managed by For

Agenda

Event Managed bywww.pharmacovigilanceday.com

French Pharmacovigilance Day

Pharmacovigilance at Horizon 2020

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 | Pharmacovigilance at Horizon 2020 - 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

Page 4: French Pharmacovigilance Dayeasy-b.it/documents/Brochure_French PV Day_2017.pdf · French Pharmacovigilance Day Pharmacovigilance at Horizon 2020 Sponsored by: Event Managed by For

How to reach the conference venue

Event Managed bywww.pharmacovigilanceday.com

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

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

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

Page 5: French Pharmacovigilance Dayeasy-b.it/documents/Brochure_French PV Day_2017.pdf · French Pharmacovigilance Day Pharmacovigilance at Horizon 2020 Sponsored by: Event Managed by For

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.

Surname

Company

Address

City

Phone

E-mail

Special Dietary Requests

Name

Job title

Post code

Fax.

Company name

Address

Mail address (If different)

City

VAT number

Post code

TWO WAYS TO REGISTER:

Event Managed by

Date Signature

Online: please register here https://frenchpharmacovigilanceday2017.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)

€ 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

[email protected]

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

INVOICING DETAILS