The document details the agenda for the 5th Annual Pharmacovigilance and Risk Management Conference held in December 2009 in Brussels, Belgium. It highlights key speakers and topics focused on drug safety, regulatory compliance, and strategies for effective pharmacovigilance. Attendees will benefit from case studies, expert insights, and discussions aimed at enhancing drug safety and risk management practices globally.

1. VIBpharma Benef
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Optimal PV and RM strategy and implementation to
ensure regulatory compliance and maximise drug safety
Tuesday 1 and Wednesday 2 December 2009, Brussels, Belgium
DISTINguISHED SPEAkERS INCLuDE: with 19 pharma and regulatory
Dr Thomas Verstraeten, Vice President, Head, Biologicals Clinical representatives on the programme,
Safety and Pharmacovigilance, gSk BIOLOgICALS
this event will provide invaluable
Dr Hans Joachim gamperl, Vice President, global Drug Safety and insight into key areas of Pv and rM
Pharmacovigilance QPPV, FRESENIuS BIOTECH
Craig Hartford, Executive Director, SRM/RMS Primary Care
Business unit Leader, PFIZER
3 HIgHLIgHTS!
Prof Philippe Van der Auwera, global Head of Safety Risk
Management (PDS) and Eu-QPPV, ROCHE ● Critical insights on the practical
Dr Duc Vu, Director, Marketed Bilogics, Biotechnology and Natural implementation of PV on a global,
Health Products, Marketed Health Products Directorate, HEALTH regional and country specific scale
CANADA
Doris Stenver, Chief Medical Officer, Consumer Safety Division,
● Take a global approach on PV and RM
DANISH MEDICINES AgENCy and Pharmacovigilance Working Party issues: clarify requirements form the
Delegate, EMEA uSA, Eastern Europe, Canada, Norway
Monica Rusu, Director PharmacovigilanceEELA, global and Denmark to ensure compliance in
Pharmacovigilance and Risk Management, SOLVAy
PHARMACEuTICALS gMBH
a global setting
Phil Weatherill, Director, global Pharmacovigilance, IPSEN ● Essential case studies on ensuring
Dr Maria grazia Zurlo, Vice President, Pharmacovigilance Strategy
legislative compliance and best practice
and Policy, PFIZER
Erica Velthuis, Senior Pharmacovigilance Scientist and
Epidemiologist, gENZyME EuROPE
ADDED EXTRA BONuS:
Dr Ennis Lee, Vice President and Qualified Person for
Pharmacovigilance, Pharma, Benefit Risk Management, ● With 19 pharma and regulatory
JANSSEN CILAg representatives on the programme, this
Bert Van Leeuwen, Director of global Drug Safety, ORgANON (now event offers you invaluable insight into
part of the SCHERINg-PLOugH CORPORATION) critical areas of PV and RM
REgISTER NOW: ■ Email: book@vibevents.com
■ Tel: +44 (0)20 7753 4268 ■ Fax: +44 (0) 20 7915 9773
Register online now at: www.vibpharma.com/pharmacovigilance

2. Programme day one Tuesday 1 December 2009
08:30 Registration 11:40 Highlighting successful RM strategies in a post approval
setting to maximise patient safety
09:00 Opening remarks from the Chair
● Critical assessments of RM techniques and methodologies
Dr Monica Rusu, Director Pharmacovigilance EELA,
● Deciding on the best strategy for managing product risk
global Pharmacovigilance and Risk Management,
● Highlighting successful techniques to monitor RM to ensure
SOLVAy PHARMACEuTICALS
minimal risk
View from the regulators: clarifying their ● Meeting the regulators’ expectations with robust RM policies
interpretation of key PV and RM legislation ● Case study: the most effective methods for risk mitigation
Rudi Scheerlinck, Director, global Clinical Safety and
09:10 Case study: the Danish approach to PV and RM Pharmacovigilance, uCB
● Highlighting the Danish PV action plan: reviewing major
elements and objectives to ensure regulatory compliance Effective approaches to monitoring and reporting
● Clarifying the impact of significant societal trends, such as Adverse Drug Reactions (ADRs)
the internationalisation and empowerment of the citizens,
12:10 Exploiting the latest technologies and methodologies
on work practices at national level to understand how this
will affect your RM strategy
for optimal ADR monitoring and reporting
● Positioning response to adverse events at the core of your
● Establishing the interrelation between the Danish
RM activity
● Medicines Agency and the EU organisation
● Developments from the cutting edge of the science and practice
● Evaluating the PSUR work share initiative and its effectiveness:
of ADR signal detection
outlining the current status from a regulatory point of view RM
● Evaluating the impact and effectiveness of electronic reporting
and risk minimisation: case study examples
Speaker TBC
Doris Stenver, Chief Medical Officer, Consumer Safety Division,
Danish Medicines Agency and Pharmacovigilance Working 12:40 Lunch and networking
Party Delegate, EMEA
Essential case studies: detailing specific
09:40 The Norwegian approach: implementing a PV plan challenges and proposing solutions
and risk minimisation activities at a national level
● Evaluating proposed RMPs: assessing how to increase their 13:50 Determining a robust drug safety strategy for vaccines
quality and usefulness to maximise the efficiency of drug to guarantee their excellence and therefore their
safety strategies acceptance for use in healthy people
● Highlighting lessons learned from the practical implementation ● Exploring the challenges to thoroughly analyse the benefit:risk
of activities proposed in RMPs to determine best practice evaluation and mitigate hazards
● Enhancing PV activities ● Generating guidelines to ensure that all adverse events are
● Reviewing educational materials to be used recorded consistently and accurately
● Handling of DHPCs ● Maximising adverse event information and data accuracy
Ingebjørg Buajordet, Head of Pharmacovigilance, through spontaneous reporting by minimising under-reporting
NORWEgIAN MEDICINES AgENCy ● Illuminating the importance of pharmacoepidemiology studies
to confirm the alerts identified by spontaneous reporting
10:10 Panel Session: Translating regulatory compliance into ● Reviewing mechanisms for active surveillance to generate
a practical, globally actionable PV strategy best practice
● Managing across multiple regulatory frameworks to ensure Dr Thomas Verstraeten, Vice President, Head, Biologicals Clinical
company-wide compliance Safety and Pharmacovigilance, gSk BIOLOgICALS
● Disseminating information and strategy effectively and creating
awareness throughout the organisation 14:20 Case study: identifying the challenges of PV for
● Practical guidance on implementation through and for affiliates orphan drugs in order to implement a strong risk
Doris Stenver, Chief Medical Officer, Consumer Safety Division, management strategy
Danish Medicines Agency and Pharmacovigilance Working ● Tackling the internal challenges of a small company to make the
Party Delegate, EMEA best use of limited resources
Ingebjørg Buajordet, Head of Pharmacovigilance, ● Building a robust PV system with limited resources
NORWEgIAN MEDICINES AgENCy ● Ensuring effective signal detection and RM during development
to fully assess drug safety
10:40 Morning refreshments and networking ● Developing signal detection and risk management strategies
post marketing for orphan drugs
Achieving successful, practical implementation ● The way forward…
of PV and RM processes Dr giuseppe Alvaro, Director, Drug Safety and
11:10 Evaluating successful strategies for PV in marketed Pharmacovigilance, SANTHERA PHARMACEuTICALS
products to maximise drug safety
● Highlighting the key factors in PV in order to provide thorough
Ensuring globally effective PV strategies
information on adverse reactions and overall drug safety 14:50 Highlighting the FDA’s Risk Evaluation and Mitigation
● Ensuring you meet the regulators’ expectations through clear Strategies (REMS)
results and increased transparency ● Reviewing the legislation around REMS to clarify what
● Determining best practice approaches for a successful is necessary
PV strategy ● Determining practical insights into REMS to ensure they
● Looking towards the future: the need for increasing transparency are successful
in PV and its impact on pharmaceutical companies ● Clarifying the opportunities to integrate various global risk
Dr Ennis Lee, Vice President and Qualified Person for management plans to create a global drug safety strategy
Pharmacovigilance, Pharmaceuticals, Benefit Risk Craig Hartford, Executive Director, SRMRMS Primary Care
Management, JANSSEN CILAg Business unit Leader, PFIZER

3. Programme day two
15:20 Afternoon refreshments and networking 08:30 Registration
15:50 Focus on Eastern Europe: reviewing the PV structure 09:00 Opening remarks from the Chair
and regulations to maximse drug safety Phil Weatherill, Director, global Pharmacovigilance, IPSEN
● Identifying the drug safety regulations in order to
enhance compliance 09:10 Roundtable morning sessions
● Effectively following the new legislation to maximise your Delegates will be able to attend three one-hour roundtable
PV strategies in Eastern Europe discussion groups from a selection of key topics. Each ses-
● Reviewing methods of monitoring risk mitigation sion will be chaired by an industry expert who will facilitate
strategies efficiently an exchange of opinions, essential experiences and learn-
● Assessing the challenges of PV in Eastern Europe to better ing related to a current aspect of PV and RM
understand where problems may occur
● Case study: highlighting examples of best practice to Roundtable 1
develop a comprehensive benefit:risk assessment
Exploring the most effective methods for the practical
Dr Monica Rusu, Director Pharmacovigilance EELA,
implementation of RMPs
global Pharmacovigilance and Risk Management,
SOLVAy PHARMACEuTICALS This session will look at the most effective methods
for implementing your RM strategies and the different
Risk based inspections: passing audits with tools you can use when gathering the data.
flying colours Monica Rusu, Director PV EELA, global Pharmacovigilance
16:20 Preparing for risk based inspections to meet the and Risk Management, SOLVAy PHARMACEuTICALS gMBH
regulators’ expectations Roundtable 2
● Reviewing the compliance report requested by the MHRA
(implemented in 2009) to fully understand what is required Highlighting the role of the QPPV
● Successfully deploying assessment algorithms to accurately This session will explore the role QPPV and their
interpret data crucial role in the overall PV plan and how best to
● Compiling an inspection readiness plan for affiliates in order manage risks and the scope of their role.
for them to address all the necessary pointers Dr Peter De Veene, Deputy European Qualified Person for
● Facilitating interaction between the central Pharmacovigilance, ROCHE
pharmacovigilance team and the affiliates to create a
successful company wide drug safety policy Roundtable 3
Dr ute Hoeffner, European Qualified Person for Reviewing global compliance in PV to maximise drug
Pharmacovigilance, NOVARTIS CONSuMER HEALTH
safety at a global level
Enhancing safety monitoring processes This session will explore global PV legislation and
through efficient epidemiology strategies find solutions to the challenges to meet disparate
16:50 Highlighting the importance of epidemiology in regulations. You will also assess how to move forward
PV and RM to increase safety monitoring to make this more viable in the future.
● Evaluating the advantages of epidemiology vs Bert Van Leeuwen, Director of global Drug Safety,
pharmacoepidemiology to determine how best to maximise ORgANON (now part of the Schering Plough Corporation)
safety monitoring
Exploring the need for epidemiology in clinical
Roundtable 4
●
development to increase the safety data available before Overcoming challenges when completing PSuRs to
the drug goes to market ensure all safety data is up to date
● Establishing the importance of epidemiology in post- This session will discuss the challenges surrounding
marketing safety to advance the level of scientific PSURs to clarify their writing, submission and
knowledge for a drug implementation. You will also analyse the work
● Clarifying the use of epidemiology in RM to ensure safety
sharing initiative to assess current practices and the
monitoring is maximised
Erica Velthuis, Senior Pharmacovigilance Scientist and success of the scheme.
Epidemiologist, gENZyME EuROPE Dr Agnieszka Majcher-Dann, Acting Qualified Person
for Pharmacovigilance, Consumer Healthcare,
Emphasising the role of the QPPV JOHNSON & JOHNSON
17:20 Assessing the growing importance of the QPPV in the Roundtable 5
evolving PV environment to understand their key role
Pharmacoepidemiology in RM: clarifying its role in
● Clarifying the scope of the QPPV’s role to fully realise the
increasing drug safety
pivotal part it plays
● Highlighting the challenges of the position and the legal This session will look at the significant links
responsibility to ensure that all requirements are met between pharmacoepidemiology and clinical
● Determining how the role has evolved and where it will head development, post-marketing safety and RM to
in the future to assess its likely impact on PV highlight how it can mitigate risk.
Dr Maria grazia Zurlo, Vice President, Pharmacovigilance Erica Velthuis, Senior Pharmacovigilance Scientist and
Strategy and Policy, Pfizer Epidemiologist, gENZyME EuROPE
17:50 Closing remarks from the Chair
12:30 Lunch
18:00 End of day one

4. Wednesday 2 December 2009
Focus on new regulatory initiatives ● Developing different methods of raising awareness (types of
campaigns, leaflets and advertisements etc) to assess which
13:40 Highlighting the Developmental Safety update is most affective
Report (DSuR) to assess the implications for ● Encouraging the public to report adverse reactions through
future PV reporting increased communication to minimise under reporting
● Emphasising the implications of increasing public ● Assessing PV reporting methods used by physicians and
expectation on drug safety to determine how to encourage patients to establish clear and concise approaches
users to discuss any perceived undesirable side effect with Prof Philippe Van der Auwera, global Head of Safety Risk
their doctor or pharmacist Management (PDS) and Eu-QPPV, ROCHE
● Improving communication with health professionals,
patients and the public to increase the accuracy of post RMPs: highlighting practical advice to ensure
marketing safety data there are no gaps in your strategy
● Developing different methods of raising awareness (types
16:20 Writing an effective RMP to mitigate delays in
of campaigns, leaflets and advertisements etc) to assess
which is most affective
submission timelines
● Reviewing the key elements to be included to ensure you
● Encouraging the public to report adverse reactions through
meet the regulators’ requirements
increased communication to minimise under-reporting
● Evaluating different approaches towards risk assessment in
● Assessing PV reporting methods used by physicians and
order to include the most effective in your RMP
patients to establish clear and concise approaches
● Determining the role of epidemiological studies in risk
Bert Van Leeuwen, Director of global Drug Safety,
management to use them to their full advantage in your RMP
ORgANON (now part of the Schering Plough Corporation)
● Troubleshooting: analysing areas where pitfalls are common
14:10 Reviewing the Periodic Safety update Report (PSuR) to minimise errors and timely delays in submission
Work Sharing Initiative to evaluate its effectiveness ● Working with different departments to generate all the
● Explaining the initiative introduced to minimise duplication necessary information
● Exploring the authorities’ work processes and timeframes ● Highlighting best practice examples demonstrating effective
to be able to work to their expectations implementation techniques
● Highlighting how successful the initiative is through Dr Agnieszka Majcher-Dann, Acting Qualified Person
feedback from the authorities for Pharmacovigilance, Consumer Healthcare,
● Assessing the challenges which have arisen to evaluate JOHNSON & JOHNSON
possible solutions
16:50 Case study: best practice methods to monitor and
● Looking forward: how to make the process more efficient
Dr Marina Belle, global Pharmacovigilance, unit Manager
evaluate RM to assess the effectiveness of your RMP
● Demonstrating different methodologies to monitor RM to
PSuR, SANDOZ INTERNATIONAL
assess effective approaches
14:40 Outlining the Canadian perspective in PV activities ● Reviewing the various tools available to determine best
● Reviewing the Canadian regulatory system and Health practice in your monitoring approach
Canada activities related to the PSUR, Phamacovigilance ● Establishing appropriate methods to measure the
and Risk Management Plan (PvP/RMP) in order to meet the effectiveness of your RM strategy
requirements ● Highlighting best practice methods and lessons learned
● Highlighting the PV "tool kit" to optimise quality and efficacy Phil Weatherill, Director, global Pharmacovigilance, IPSEN
while minimising the risks that may be associated with
health products approved for sale in Canada
17:20 Experiences of a small company: submitting
● Assessing experiences and challenges encountered in the a successful RMP supporting the Eu approval of
review activities of PSUR, PvP/RMP in Canada to demonstrate a therapeutic antibody
trouble areas and best practice ● The company's drug safety and the antibody's properties as
● Establishing signal detection activities using “Canada necessary background information
Vigilance database” and other international adverse drug ● A safety strategy during clinical development as an essential
reaction databases as well as information from PSURs to tool for risk evaluation
create a global drug safety outlook ● The presentation of safety data in the dossier (CTD) impacts
Dr Duc Vu, Director, Marketed Biologics, Biotechnology the RMP
and Natural Health Products, Marketed Health Products ● The establishment of the RMP requires early planning and
Directorate, HEALTH CANADA multiple input
● Lessons learned
15:20 Afternoon refreshments Dr Hans Joachim gamperl, Vice President, global Drug Safety
and Pharmacovigilance QPPV, FRESENIuS BIOTECH gMBH
key factors in today’s changing PV environment
15:50 Increasing public awareness of risk to ensure that 17:50 Closing remarks from the Chair and champagne
patients fully understand the benefit:risk analysis prize draw
of a drug hence can take an informed decision with
their prescribing physician 18:00 End of conference
● Emphasizing the implications of increasing public
expectation on drug safety to determine how to encourage
users to discuss any perceived undesirable side effect with
their doctor or pharmacist
● Improving communication with health professionals,
patients and the public to increase the accuracy of post
marketing safety data

5. Media partners About the event
Pharmaceutical Technology is Following the enormous success of our Pharmacovigilance and
used daily as a means of creating Risk Management event earlier this year, VIBpharma is proud to
partnerships and as a point of announce the dates for our fifth annual Pharmacovigilance and
reference by professionals within the pharmaceutical industry. Risk Management conference this December. The role of drug
This comprehensive resource supplies the latest news releases, safety both in drug development and postmarketingsurveillance
detailed information on industry projects, white papers, has increased enormously over recent years, especially in an
event information and a thorough breakdown of products and era where the public are much less tolerant to medical risk and
services. www.pharmaceutical-technology.com have many more ways in which to express their opinions. With
a continually changing regulatory environment it is imperative
Drug Development Technology that you are kept up to date with the latest changes to develop a
is a procurement and reference robust Pharmacovigilance strategy in which there are no gaps.
resource providing a one-stop-
shop for professionals and decision makers within the VIBpharma’s Pharmacovigilance and Risk Management
drug development and medicines industry. We provide a conference will bring together major pharma and biotech
comprehensive breakdown of drug development contractors manufacturers as well as the regulators to find solutions to
and suppliers, up-to-date news and press releases, white this increasingly important issue. This event will cover topics
papers and detailed information on current industry projects such as effectively monitoring RMPs and best practice in
and trends. Our recruitment area provides career information their implementation; exploring global Pharmacovigilance
and the latest job vacancies in the field. approaches and creating global risk minimization strategies;
www.drugdevelopment-technology.com increasing public awareness of the benefit:risk ratio of
medicines and ensuring physicians fully comply to the
The Business Review websites are Pharmacovigilance regulations; and ensuring the data exchange
your number one stop for all the
between companies.
latest news, comment and industry information. Each Business
Review website offers content that is produced by a dedicated
This educational two-day conference, tailored to maximise the
team of journalists and global industry experts. In addition to
sharing of knowledge and expertise and to promote networking
the free content made available on the sites an intelligence
for professionals in this area, will ensure you effectively
store will provide you with premium market analysis reports
manage Risk Management with current medicines to mitigate
from the leading global suppliers of market research and
any risks to patients.
industry analysis.
Pharmaceutical Business Review is
the world's leading pharma website,
being used by over 100,000 visitors TESTIMONIALS – Here is what previous delegates
every month. For further information have said about previous PV conferences
contact jsharp@industryreview.com
“Very useful with a lot of hot topics”
World Pharmaceutical Frontiers Patient Safety Manager, ASTRAZENECA
The pharmaceutical industry is
World Pharmaceutical Frontiers www.worldpharmaceuticals.net
“Very good to meet people; fruitful discussions”
changing fast. There are more regulations, technologies, CQA PV Specialist, NOVARTIS
faster product launches and shorter product life cycles than
ever before. World Pharmaceuticals frontiers is, and will “It was very useful and lively meeting and I have the
continue to be, at the forefront of these changes, so visit us opportunity to interact with many other colleagues
at www.worldpharmaceuticals.net and stay up to date with not only from the pharma industry but also the
all latest developments regulators. We shared a lot of experience and I
learned a lot!”
Director of PV, SOLVAy PHARMA
Who should attend:
“A good choice of speakers and enough time devoted
Heads, Directors and Managers from pharma and biotech
to discussion”
manufacturers working in the following areas:
Head of Drug Safety, BOEHRINgER INgELHEIM
● Pharmacovigilance
“Globally a good overview with current practices
● Qualified Person (QP) for PV
and issues in PV. A good opportunity to exchange
● Drug Safety
experiences with colleagues”
● Benefit-Risk Management Senior Director, Safety and Compliance, IPSEN
● Medical INNOVATIONS
● Risk Management
“Good interaction and variety of speakers. Overall I
● Clinical Operations
enjoyed the experience and exchanged best practice
● Clinical Safety
with others”
● Epidemiology
PV Manager, SCHERINg PLOugH
● Product Safety and Quality Management
● Regulatory Affairs “Very high quality speakers and the roundtable
discussion groups allowed a good exchange of
experiences”
Drug Safety Specialist, MERCk SERONO
“Very good, well organised conference”
Do you wish to exhibit your products Director, Marketed Biologicals, HEALTH CANADA
and services at this exclusive event? “Highly professional speakers and audience, very
knowledgeable and open. Pleasant overall”
Contact details: Paul Adams, Drug Safety Solution Manager, QuINTILES
pauladams@arena-international.com, +44 (0) 20 7753 4259

6. Booking Form
Pharmacovigilance and Risk Management, Tuesday 1 and Wednesday 2 December 2009, Brussels, Belgium
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6.10.2009 3.11.2009 3.11.2009
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