Tuesday, November 20th, 2018French Pharmacovigilance Day

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Paris, France

PHARMACOVIGILANCE: FUTURE CHALLENGES AND OPPORTUNITIES

Sponsored by:

Hilton Paris La Défense2 Place de la Défense - Paris

Il Vaso di FioriMichela Rimondini e Monia Dardi

Taking part in the event, you support

“The Vase of Flowers” project

French Pharmacovigilance Day

Scientific Board

ABOUT

www.pharmacovigilanceday.com

For the fourth consecutive year, Life Science Academy is organising a French Pharmacovigilance Day

to be held in Paris on 20 November 2018.

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 con-

tract 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 Fran-

ce 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

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:

in pharmaceutical and Biotech companies, Clinical Research Organizations (CROs) and publich health centers.

Clinical operation dept.

Statistic dept.

Medical Affairs dept.

Regulatory Affairs dept.

Quality & Compliance dept.

Pharmacovigilance dept.

Event managed by

PHARMACOVIGILANCE: FUTURE CHALLENGES AND OPPORTUNITIES

Amir Lahouegue Head of Patient Safety, Medical Information & Neuroscience Therapeutic Area Medical Affairs at AstraZeneca

Solange Rohou

Sr. Director Regulatory Affairs & Policy, Europe at AstraZeneca

Erick Gaussens

Executive Advisor and Chief Scientific Officer at ProductLife Group

AGENDA |

www.pharmacovigilanceday.com

Event managed by

PHARMACOVIGILANCE: FUTURE CHALLENGES AND OPPORTUNITIES

French Pharmacovigilance Day

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

www.pharmacovigilanceday.com

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HOW TO REACH THE CONFERENCE VENUE

2 Place de la Défense - Paris

Hilton Paris La Défense

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

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)

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

CAR ACCESS

From Paris Orly Airport

Distance from Hotel: 43 km Drive Time: 40 min.

Distance from Hotel: 35 km Drive Time: 40 min.

From Charles de Gaulle Airport:

Station stop “La Défense Grande Arche” by using:

Download the Events Summary 2018

Exclusive benefits and high impact branding

before, during and after the conference.

Sponsor the event and take the chance to network with all attendees!

SPONSORSHIP

OPPORTUNITIES

For further information

Please visit the conference website or contact the organisational offices:

Ilaria Butta Phone +39 (0)35.4123594 | ilaria.butta@LSacademy.com

Two ways to register

Date Signature

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.

€ 655,00 Early Bird fee extended until November 9th, 2018

€ 765,00 Ordinary fee (after November 9th, 2018)

€ 570,00 Patronage members fee (Association )

€ 430,00 Academy, Public Administration, Freelance

(please, specify )

For any additional information, please contact:

Ilaria Butta | ilaria.butta@LSacademy.com Phone: +39 (0)35.4123594

Online please register here https://frenchpharmacovigilanceday2018.lsacademyevents.it/orders/new In this case, you can choose to pay by credit card or by bank transfer

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

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