A Global Pharmacovigilance Network:

Opportunities and Challenges

Il Vaso di FioriMichela Rimondini e Monia Dardi

A portion of the proceeds from

this event are donated to the

“Vase of Flowers” project.

International Pharmacovigilance Day

2nd

20

20

Event managed by

MadridSpain

2020

14 September 2020 15 September 2020

13.15 - 17.50 09.00 - 17.00

Sponsor

ABOUTInternational Pharmacovigilance Day

LS Academy is delighted to welcome you to the 2nd International Pharmacovigilance Day conference to be held on

13th & 14th May 2020 in Madrid, Spain. The pharmacovigilance world is undergoing a phase of rapid change with new

technologies, dynamic regulations and increasing complexity in data sources.

This one-and-a-half-day event will showcase renowned international speakers addressing hot topics in pharmacovigi-

lance and highlighting the opportunities and challenges in managing them. Among the main topics of the day:

• Dynamic international PV legislation: what’s hot right now

• Regulatory Authority viewpoint: the new inspection mood

• New Safety regulations affecting device-drug and drug-device combination products

• New PRAC strategy for impact assessment of pharmacovigilance

• Digital Health: New initiatives, new information sources, big data and social media

• Handling safety information received via digital health apps

• WEB-RADR & new technologies

• Electronic Product Information & creating a product e-label

• Developing effective global PV systems

• Pharmacovigilance in first-in-human trials & monitoring

• ePatient involvement

And much more!

A pool of exceptional international experts addresses and compares on the hot topics that arise on a daily basis and

on an international scale.

Participants will have the opportunity to take part in up-to-date discussions and to share their own experiences within

greatly qualified international expertise.

The International PV Day attractive traits include:

• A Scientific Committee guaranteeing updated and strictly scientific topics, quality discussions

and absence of any commercial presentations.

• Different international perspectives presented over the event: regulatory authorities, industry, CROs

• Open discussions and group working sessions.

• Notable networking opportunities.

• An easy to access venue and friendly environment.

A Global Pharmacovigilance Network: Opportunities and Challenges

www.lsacademy.com

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This conference is designed to benefit functional/technical professionals working in the pharmaceutical and health

care area dealing with the Pharmacovigilance system, such as:

• Safety and Pharmacovigilance dept.

• Clinical operation dept.

• Statistic dept.

• Medical Affairs dept.

• Medical Information dept.

• Regulatory Affairs dept.

• Quality and Compliance

Also, Directors/Seniors Directors/Executive Directors and Vice Presidents /Senior Vice Presidents/Executive Vice Pre-

sidents and Heads/Leaders/Partners of: CROs and CMOs, Clinical Research Sites, Pharma, Biotech and Medical Devi-

ces Industries.

Scientific Board

Who should attend?

Independent Pharmacovigilance Adviser

Founder of Unique Advice

Independent Pharmacovigilance

Consultant

Director of Pharmacovigilance

Quality Assurance

at AbbVie

QPPV Office Vice President

at Novo Nordisk A/S

Irene Doris Stenver

Jabeen Ahmad Rebecca Webb

Pilar Carrero

ABOUTThe event is fully designed for professionals involved in medicines or device safety, pharmacovigilance, digital heal-

thcare, clinical research, development and management of pharmaceutical and combination products.

LS Academy, leader in the field of scientific continuing education, welcomes you to an outstanding International Phar-

macovigilance event for constant professional development and up-to-date discussions in this extremely relevant

scientific area.

www.lsacademy.com

• Legal dept.

• Software Developing dept.

• Medical Devices Manifacuring Companies

• University Faculties scientists who are related to clinical and

medical research (Senior, Associate and Assistant Professors,

Research Scholars, Phd students)

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Further information will be available soon.

Official Language: English

A Global Pharmacovigilance Network: Opportunities and Challenges

International Pharmacovigilance Day AGENDA

www.lsacademy.com

Confirmed Speakers

Medical Devices: new combination products in the pipeline and a new legislation

Jan Bart Hak – Head Medical Device Team at ProPharma Group

Prac insights and strategy to measure impact of pharmacovigalance

Doris Stenver – Independent Pharmacovigilance Adviser, Founder of Unique Advice

An industry appoach on handling safety information received viadigital health apps

Birgitte Scharling – Pharmacovigilance Policy Expert at Novo Nordisk

The Future of the drug safety professional

Pilar Carrero – QPPV Office Vice President at Novo Nordisk

The E-Label: Case Studies on Doing a Great e-label

Rüdiger Faust – Head Telematics & Digital Solutions at Grünenthal GmbH

Contribution of the industry to the development of effective global and national pharmacovigilance

system - EFPIA LATAM initiative to evaluate the divergence of pc requirements in the region

Santiago Schiaffino – Regional PV Head EM LATAM at Boehringer-Ingelheim

How are inspection and audit programmes adjusting to changes in the pv landscape?

Current trends and reflections

Rebecca Webb – Director of Pharmacovigilance Quality Assurance at AbbVie

Opportunities arising from WEB-RADR for digitisation of vigilance activities

Phil Tregunno – Vigilance, Intelligence and Research Group Manager at MHRA

Digitial Health: Data Management, AI and New information Sources

Nikolai Constantin Brun – Director of Division, Medical Evaluation & Biostatistics, CMO at Danish Medicines Agency

Effective PV System Development: An overview of EFPIA IPVG Consensus Paper

Jabeen Ahmad – Independent Pharmacovigilance Consultant

Pharmacovigilance Inspections by the spanish medicines and medical devices agency:

trends and analysis of common findings

Ernesto Vera Sanchez – Head of GCP and PHV Inspectorate at AEMPS - Spanish Medicines and Medical Devices Agency

Real life experience on an acute treatment, a chronic treatment and a clinical trial setting:

how can we incorporate the patients’ voice & perspectives into the pharmacovigilance

system in order to bring safety to patient?

Sandrine Lavallé – EUPATI Luxembourg representative

Mitchell Silva – CEO at Esperity

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www.lsacademy.com

S P O N S O R

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Our medical literature monitoring solution can make your drug safety reporting process more cost-effective,

efficient and compliant. Here’s how:

• We have the industry’s only truly end-to-end approachto literature monitoring, covering every aspect of thedrug safety monitoring process

• Our fully-validated drug safety monitoring tool, DrugSafety Triager, eliminates duplicated content, reducesthe volume of literature for review and automaticallyoutputs relevant patient safety references

• Our workflow provides instant reports for monitoringKPIs and for vendor oversight

• We use machine learning to identify ICSRs inliterature, speeding up the process and reducing errors

• Our solution offers an inspection-ready audit trail,supporting compliance across the entire process

Get in touch with us today to understand how we can help improve

your medical literature monitoring:

sales@dialog.com

dialog.com/contact-us

Your global pharma service provider

Formulation development

Clinical & Pre-clinical

Regulatory affairs / Dossier development & publishing

Full pharmacovigilance services

Medical translations

Medical devices

Visit our website: www.elc-group.com

Europe ⦁ CIS ⦁ South East Asia ⦁ North America ⦁ South America

ELC Group is a fully-fledged global regulatory partner, working with major

pharmaceutical stakeholders for over a decade.

From the development stage through to the implementation of clinical trials, completion

of product registration, and successful marketing of the product, ELC Group aligns itself

as a strategic partner to help pharmaceutical companies achieve their goals.

For Further information

Please visit the conference page on the website or contact the organisational offices:

Francesca Archetti Phone +39 (0)35.4123594 | francesca.archetti@lsacademy.com

HOW TO REACH THE CONFERENCE VENUE

Download the Events Summary 2020

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

www.lsacademy.com

Venue

Hotel VP Jardin Metropolitano

Av. Reina Victoria, 12 28003 Madrid

The hotel is located next to Cuatro Caminos Square, close to Azca business area, Nuevos

Ministerios, the Santiago Bernabéu stadium and the university campus. This hotel’s interior

is decorated with plants and palm trees.

Transport options

BUS STATION

Cuatro Caminos 40 mt

SUBWAY STATION

Cuatro Caminos 100 mt

TRAIN STATION

Nuevos Ministerios 1,5 km

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How to register

*For Italian companies: + 22% VAT

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.

€ 940,00* Super Early Bird fee until 14th June 2020

€ 1.090,00* Early Bird fee until 14th August 2020

€ 1.250,00* Ordinary fee (after 14th August 2020)

€ 730,00* Academy, Public Administration, Freelance

(please, specify )

By email o fax

please fill the registration form below for each attendee and send it by

email: francesca.archetti@lsacademy.com or by fax: +39(0)35.4501262

In this case, you can pay by bank transfer.

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 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 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,

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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

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Terms & Conditions

For any additional information, please contact:

Francesca Archetti | francesca.archetti@LSacademy.com | Phone: +39 (0)35.4123594

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