Comparison of Pharmacovigilance

in the US, Europe and Latin America

Rachael
DiSantostefano
DanielLindwall
Director/Benefit Risk,
Vice
President
Epidemiology

MilbhorDSilva

JohnSullivan

Vice President & Head,

Safety Science

15+ Experience Based

Case Studies

Therapeutic Area Head,

Inflammation and Nephrology
Safety

AndersLindholm
VP, Head of Drug Safety
Therapeutic
Area - Inflammation &
Immunology

10+ One to One

Networking Hours

Impact of artificial Intelligence

ICSRs VOLUME: Learn how to deal with increasing volume of ICSRs

INTEGRATION OF DATABASES: Globalization of Pharmacovigilance

and integration of Databases

CIOMS/WHO GUIDE: Updates in CIOMS/WHO Guide for Active Vaccine

Safety Surveillance

PV PROCESSES: Compare the current Pharmacovigilance Processes in the

US, Europe and Latin America

BIG DATA AND PV: How to use Evidence from Big Data to assess potential

Gold Sponsors

Silver Sponsor

Global Pharmacovigilance,
Head TA Oncology - ICSR
Processing

2,5 Full Day with

Presentations

ARTIFICIAL INTELLIGENCE: The Future of Pharmacovigilance and the

Safety Concerns during the pre-approval

AlexanderKluczka

Walter Straus

Associate Vice President,

Therapeutic Area Head, Clinical
Safety & Risk Management

3 Interactive
Group Discussions

EVENT
DESIGNED FOR
Members of board, C-level, Senior Vice
Presidents, Vice Presidents, Directors,
QPPVs and Heads of departments from
pharmaceutical industry involved in:
Pharmacovigilance
Drug Safety
Safety & Risk Management
Signal Detection
Benefit-Risk Assessment
Safety Evaluation
Regulatory Affairs,
Pharmacovigilance
PV Governance
Safety Surveillance
Pharmacovigilance Operations
PV Inspection and Audit Readiness
Patient Support Programs
Market Research Programs
Clinical Safety
Medical Safety
ICSR
Medical Information
Pharmacoepidemiology

www.pharmacovigilancesummit.com

CASE STUDIES PRESENTED BY

John Sullivan

Walter Straus

Therapeutic Area Head, Inflammation and

Nephrology Safety

Associate Vice President, Therapeutic Area Head,

Clinical Safety & Risk Management

Amgen

Merck

Sharon Donatucci

Frank Hong

Chief Pharmacovigilance Sciences Office

Executive Director

Ashfield Pharmacovigilance

Novartis

Milbhor DSilva

Mirza Rahman

Vice President & Head, Safety Science

Vice President,Global Head of Pharmacovigilance

& Medical Affairs

Astellas

Otsuka

Alexander Kluczka

Global Pharmacovigilance,
Head TA Oncology - ICSR Processing

Saeed Amin

Bayer

Otsuka

Director, Global Head of Safety Data Management

Anders Lindholm

Roy Mansfield

VP, Head of Drug Safety Therapeutic

Area - Inflammation & Immunology

Senior Director - Safety & Risk Management

Pfizer

Celgene

George van Baelen

Shaun Comfort

Associate Director and Sr. Safety Science Leader

Head Pharmacovigilance Latin America &

Carribean

Genentech

Shire

Anupam Agarwal

Veronique Kugener

Senior Vice President & Head, Global

Pharmacovigilance

Director, Drug Safety & Public Health,

Gilead Sciences

Takeda Pharmaceuticals International

Rachael DiSantostefano

Sarah Daniels

Director/Benefit Risk, Epidemiology

Senior Partner

Janssen

TranScrip

Marie Aavang Geist

Associate Director, Safety team lead

Lundbeck

PRE-CONFERENCE WORKSHOPS
Workshop A:

Global Harmonization of Pharmacovigilance

18 October 2016 (15:00-16:00)

Workshop B:

New technologies and processes in Risk Management

and Pharmacovigilance
18 October 2016 (16:00-17:00)

Comparison of the US, EU and emerging markets

Big Data and Digital in Pharmacovigilance

pharmacovigilance legislation.

Data collection - collection of high-quality data on the safety of

Harmonizing the risk management strategies globally.

How do different countries deal with multiple different

medicines.

requirements for PV reports?

Utilizing social media platforms to monitor, report and analyse

data.

What are the examples and consequences of PV disharmony?

Identification and evaluation of safety signals.

How are various ICH regions working to implement global

Artificial and Machine Intelligence

harmonization practices in the areas of drug safety and risk

management?

BOOKING LINE: Tel.: +421 221 025 322 / Fax: +421 252 444 220

www.pharmacovigilancesummit.com

DAY 1 Wednesday 19 October 2016

08:20 Registration and Morning Coffee
08:50 Opening Remarks from the Chairperson
09:00 SPEED NETWORKING SESSION

Dont forget your business cards!

GREAT 15 MINUTES ICE-BREAKING AND
NETWORKING ACTIVITY to meet
your peers before we start.
09:10 CASE STUDY

Using evidence from big data to assess potential

safetyconcerns during the pre-approval
proactively

This use-case will demonstrate how big data can be mined to prepare
for and support a new drug application for an anti-infective therapy, with respect to a rare event noted in non-human studies. Animal
studies showed QT-interval shortening. In anticipating a potential
line of enquiry from the regulator at an Advisory Committee on the
impact of QT-interval shortening on patients treated with the drug
product, the real world data (big data) were mined in a structured way
to explore the actual frequency of this event in the real world use
conditions for products that have been associated with QT-interval
shortening and the life-threatening or fatal consequences of this
event. A study was conducted using a large US administrative database. We explored the use of real world data to assess the risk of
excess ventricular arrhythmia and cardiovascular mortality associated
with the use of an approved drug (for a certain indication) that has a
labelled warning for QT-interval shortening compared to established
drugs approved for the same indication with no such label warning.
This presentation will discuss the design, technical and operational
details, and render a view on the potential public health impact of the
drug-induced QT-interval shortening and its clinical consequences.

Demonstrate the application of the real world data to assist with

the pre-approval safety evaluations for potential drug-event
pair(s)
Discuss design elements, selection of control(s), methodology,
statistical testing
The nature of the collaboration and the matrix model that helped
meet the program objectives
Lessons learned

Milbhor DSilva
Vice President & Head, Safety Science
Astellas

09:50 CASE STUDY

Benefit-Risk Decision Framework Utility

Throughout the Product Lifecycle

The Framework succinctly summarizes the benefits and harms of a

product and is a helpful tool in several situations, such as portfolio
review decision making during development, supporting the B-R discussion in the NDA/MAA, for post-marketing portfolio review and
prioritization and finally, in communication to the public and patients
for transparent understanding of the key product benefits and risks.
Implementation of the B-R decision making tools and thinking will
require continued focused development resources.

Benefit-Risk evaluations and Frameworks

Incorporation into a companys decision making processes
Potential utility for communicating benefits and risks to patients
BOOKING LINE: Tel.: +421 221 025 322 / Fax: +421 252 444 220

Anders Lindholm
VP, Head of Drug Safety Therapeutic Area - Inflammation
& Immunology
Celgene

10:30 NETWORKING COFFEE BREAK

11:00 CASE STUDY

Post-Approval Benefit-Risk: Bringing

in the Patients Perspective

Assessing benefits and risks of medicines is a central to medical product development and regulatory and healthcare decision-making.
However, the trade-offs between desired and tolerable risks can differ
depending on your perspective as a patient, physician, or regulator.
This presentation will review recent regulatory and patient-focused
initiatives in the benefit-risk (B-R) assessment and illustrate the
increasing importance of the patient perspective in the B-R decision
making.

Emerging policies and regulatory expectations of structured B-R

assessment
Incorporating the patient perspective
Case studies in patient-focused B-R assessment
Future directions in B-R assessment and reporting

Rachael DiSantostefano
Director/Benefit Risk, Epidemiology
Janssen

11:40 PRESENTATION
Presentation by
TBA
ProQuest

12:20 LUNCH
14:00 CASE STUDY

Artificial Intelligence, Finance, and the Future of

Pharmacovigilance

Currently Pharmacovigilance (PV) is primarily conducted manually,

using thousands of highly trained staff globally, to process, evaluate
and submit/modify risk information to facilitate safe medication use.
The field is evolving and there is increasing use of digital computers
to assist with storing and processing the increasing information volume. However, much of PV is still largely manual, slow, and expensive.
This is in contrast to other industries that have adopted sophisticated
automation and are now implementing Machine Learning/Artificial
Narrow Intelligence (ML/AI) systems, which are rapidly expanding
into areas traditionally performed by humans (i.e. Algo Trading, etc.). A
similar machine revolution has not occurred within PV - yet. By drawing parallels from recent changes in the financial industry, the author
describes how this technology could significantly transform aspects
of PV, hopefully to create a future of scalable human/machine PV
systems producing more consistent and reliable safety information for
Patients, Prescribers, and Health Authorities.

Currently, Pharmacovigilance (PV) is primarily conducted manually using thousands of highly trained staff globally
Other industries (e.g. Finance) are being transformed with
rapid adoption of automation and Machine Learning/Artificial
Intelligence (ML/AI) systems
ML/AI is rapidly expanding into areas traditionally performed by
humans (i.e. Algo Trading, etc.) Similar adoption of automation
and cognitive technology could significantly transform aspects
of the PV
The author presents one vision of what such a future might look
like

Shaun Comfort
Associate Director and Sr. Safety Science Leader
Genentech
www.pharmacovigilancesummit.com

DAY 1 Wednesday 19 October 2016

14:40 CASE STUDY

18:00 DISCUSSION

Managing Change: Creating a Global Pharmacovigilance

Organization

Interactive Panel discussion

During this presentation, the audience will learn of a transformative

change that has recently taken place in a mid-sized pharmaceutical
company. It went from having a regionally fragmented pharmacovigilance organization, to one that is now globally harmonized, with a
focus on patient safety and compliance. In this session, we will discuss
why and how we made this successful transformation, with a focus on:

Purpose - Patient Safety and Compliance

Leadership and Change Management
Structure, Process, & Outcome
Governance, People, & Technology

Mirza Rahman
VP, Global Head of Pharmacovigilance
Otsuka

15:20 PRESENTATION

Solicited Report

The challenge of handling incomplete data from reporters

(Patient Assistance Programs, Financial Assistance Programs)
The challenge of obtaining follow-up from patients
The impact on the safety profile of the drug

Sharon Donatucci
Chief Pharmacovigilance Sciences Office
Ashfield Pharmacovigilance

16:00 NETWORKING COFFE BREAK

16:30 CASE STUDY

Risk management and risk minimisation- differences between EU and US

FDA and EMA have different approaches to handling of risks when a
drug is newly approved and in the post-marketing setting. The GVP
module V has great focus on the management of risks and on post-authorisation studies, while the FDA guideline focuses on risk minimisation. This presentation will highlight the differences in requirements
between EU and US risk management and risk minimisation in the
post marketing setting, and provide examples of how these differences can lead to different post-authorisation measures.

GVP modules V and XVI

FDA guidance for industry on REMS
Examples of differences between EU and US in the management
of risks

Marie Aavang Geist

Associate Director, Safety team lead
Lundbeck

17:10 CASE STUDY

Un-blinding Clinical Safety Data - the benefits and

risks of in-company un-blinding
In a view of the draft FDA guidance with respect to the safety assessment for IND safety reporting, this presentation will discuss the
potential risks to study integrity and benefits for ensuring a patients
safety of un-blinding adverse event data for ongoing studies within
the sponsor company.

Roy Mansfield
Senior Director - Safety & Risk Management
Pfizer
BOOKING LINE: Tel.: +421 221 025 322 / Fax: +421 252 444 220

In this session, the audience has an opportunity to ask questions and

have an open interactive discussion with the discussion panellists..

Maintaining a focus on the patients safety through the

benefit-risk management.
How to maximise the benefit and minimize the risk?
Pre-marketing vs. post-marketing risk assessment.

Support decision-making on the safety and benefit-risk

profile of a medicine.

Lessons learned from the benefit-risk communication and

minimization strategies

Moderator:
Sciformix
Rachael DiSantostefano
Janssen

Anders Lindholm
Celgene

Roy Mansfield
Pfizer

George van Baelen

Shire

18:30 Reception

Cocktail reception

All attendees will have a great opportunity to discuss with their peers.

ARE YOU A
SOLUTION
PROVIDER?
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the relevant industry Solution Providers to participate in our events. We provide you with
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possibilities accessible by all summit delegates.

TO BOOK YOUR
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Contact please
Mr. Sam Khalaf
on +421 221 025 324 or
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www.pharmacovigilancesummit.com

DAY 2 Thursday 20 October 2016

08:20 Registration and Morning Coffee

08:50 Opening Remarks from the Chairperson

09:00 SPEED NETWORKING SESSION

Dont forget your business cards!

GREAT 15 MINUTES ICE-BREAKING AND
NETWORKING ACTIVITY to meet
your peers before we start.

George van Baelen

Head Pharmacovigilance Latin America & Caribbean
Shire

09:10 CASE STUDY

12:20 PRESENTATION

Update: CIOMS/WHO Guide for Active Vaccine

Safety Surveillance

Benefits and Challenges of Outsourcing

Pharmacovigilance Activities - Results of a Survey
of Current Industry Practices

A working group of the Council for International Organizations of

Medical Sciences (CIOMS) has recently released a guidance document
describing the role of active surveillance in vaccine pharmacovigilance. The Working Group was specifically interested in addressing the
unprecedented demand for improved pharmacovigilance in low- and
middle-income countries. There is a growing number of vaccines being
developed primarily or exclusively for diseases endemic to these
regions, which lack the robust spontaneous adverse reporting systems
sometimes found in other regions. This presentation will provide the
problems and solutions described in the report.
Walter Straus
Associate Vice President, Therapeutic Area Head, Clinical Safety
& Risk Management
Merck

Several Latin American countries are starting to implement a PV

infrastructure
Concerted Approach to Alignment of PV and RM activities across
Latin America and the Caribbean
The role of the PAHO and the EU
Integration Projects and Build-out of PV and Risk Management
Everyday Realities of PV and RM in Latin America

In recent years most pharma companies re have turned to

outsourcing various elements of drug safety pharmacovigilance
There are many different models for achieving this outsourcing
but with varying degrees of success
We undertook a survey among pharma companies of various sizes
to try better understand what aspects of pharmacovigilance are
outsourced and what the perceived benefits and challenges are

Sarah Daniels
Senior Partner
TranScrip

13:00 LUNCH

09:50 CASE STUDY

14:20 CASE STUDY

Risk Management Plans

Cardiovascular safety issues during phase I-III trials for non-cardiovascular drug development

Frank Hong
Executive Director
Novartis

10:30 NETWORKING COFFE BREAK

11:00 CASE STUDY

Decision making for safety

Explain safety framework

Component of decision making
Threshold of safety decision
Safety issues matters
Guidance
Framework

Veronique Kugener
Senior Vice President & Head, Global Pharmacovigilance
Takeda Pharmaceuticals International

11:40 CASE STUDY

Pharmacovergence: Integration of PV and Risk

Management across Latin America

An overview of the numerous national and transnational normalization

initiatives of the legal and regulatory frameworks for PV and RM
in Latin America and the Caribbean.
BOOKING LINE: Tel.: +421 221 025 322 / Fax: +421 252 444 220

Collection of information and evaluation of cardiovascular endpoints during the clinical trials
Special issues related to oncology drug development
Standardized Clinical report form for collection of cardiovascular
endpoints during the clinical trials

Anupam Agarwal
Director, Drug Safety & Public Health
Gilead Sciences

15:00 CASE STUDY

How to process 1 Million ICSRs

Big Pharma has seen a continuous increase in the Adverse Event

reports for years, driven by evolving regulations, growing numbers of
patient support programs and widening product portfolios. The prospect of 1 million case cycles per year requiring processing is no longer
just a theoretical consideration, but a very real challenge to be tackled
within the next five to seven years. This session will discuss strategies
of how to deal with ever-increasing volumes of ICSRs, including:

Flexible workload management

Successful outsourcing
Process optimization
Automation
Specialization

Alexander Kluczka
Global Pharmacovigilance, Head TA Oncology - ICSR Processing
Bayer
www.pharmacovigilancesummit.com

DAY 2 Thursday 20 October 2016

15:40 DISCUSSION

Interactive Roundtable Discussion

All attendees will have a great opportunity to discuss a selection of

the most interesting topics addressed during the conference in small
groups with their peers.

New technologies to determine the risk in PV-signal detection.

The use of Data Mining to Identify Product-Event Combinations.
Identification and evaluation of safety signals.
Difference of managing signals in development vs. post marketing
phase.
Research programs and social media programs for collection of
ADR.

Saeed Amin
Director, Global Head of Safety Data Management
Otsuka
Mirza I. Rahman
VP, Global Head of Pharmacovigilance
Otsuka

17:20 CASE STUDY

Safety Assessment in Phase 1 Healthy Volunteer Trials

16:10 NETWORKING COFFE BREAK

The recent unfortunate experience in a French phase 1 Contract

Research Organization has focused attention on the safety of healthy
volunteer trials. This has resulted in changes in the behavior of regulatory authorities. This presentation will address issues related to
healthy volunteer safety and changes in the regulatory landscape.

16:40 CASE STUDY

Disruptive Innovation: Creating a Single Global Safety

Database

All Attendees
Discuss with your peers and share knowledge

Innovation does not simply mean utilizing the newest technology!

Instead it involves being creative to come up with new ideas to
address old problems, as was the case when we set out to create a single global safety database, especially in light of multiple past failures
in this area in the pharmaceutical industry. The challenges of going
from two databases for safety data from Japan and the rest-of-theworld, to one database, will be presented, along with why and how we
created this database. We will focus on:

Compliance and Global Oversight

Simplicity and Cost-effectiveness
Process Design and Project Management
Technological Solutions

Sponsors need to understand risks for early phase trials

based on non-clinical studies
Trials need to be appropriately designed to ensure
subject safety
Healthy volunteer studies are generally safe
for research subjects
Changes in regulatory requirements for phase 1 studies
are a reality

John Sullivan
Therapeutic Area Head, Inflammation and Nephrology Safety
Amgen

18:00 CLOSING REMARKS FROM THE CHAIRPERSON

VENUE
BOSTON

BOSTON MARRIOTT COPLEY PLACE

The Risk Management and Pharmacovigilance America Summit
will be placed in Boston Marriott Copley Place, 110 Huntington
Ave, Boston MA 02116, United States.
Things to do in Boston:
No. 1 thing you should do while in Boston is to follow the 2.5mile redbrick trail from Boston Common to Bunker Hill.
Theres nothing quite like taking in a game at Fenway Park,
one of Americas most beloved baseball stadiums since it
opened in 1912.
You dont have to be a coed to warrant a trip across the
Charles River to nearby Cambridge. Home to 2 of the most
prestigious universities in the country, Harvard and the Massachusetts Institute of Technology (MIT).
I am looking forward to welcoming you personally at
the Risk Management and Pharmacovigilance America
Summit in October!
Vladka Krasinska
Production Manager

BOOKING LINE: Tel.: +421 221 025 322 / Fax: +421 252 444 220

Allan Lloyds is the leading provider of most diversified business intelligence events. Quality has
always been our priority and we understand that
every industry is unique and has different needs
and challenges. We turn events to unique experience based on interaction, discussions and networking. Today, we are trusted by senior experts
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bring in a diverse group of speakers and has sessions on topics that go beyond usual case studies.
These Summits can change the course of your
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