This document provides information about the 7th Annual Pharmacovigilance conference to be held on January 30-31, 2012 in London. The conference will discuss current pharmacovigilance regulations and strategies to improve drug safety, with key speakers from major pharmaceutical companies. Topics will include pharmacovigilance throughout a drug's lifecycle, risk management, safety surveillance, and new EU regulations. Attendees will gain insights on evaluating safety signals and benefit-risk assessments to increase drug safety.

1. 7th Annual
Pharmacovigilance
Evaluating the best surveillance strategies and risk management to increase drug safety
30th – 31st January 2012, Visiongain Conference Centre, London, UK BOOK NOW!
Key Speakers
Dr. Philip Eichorn, Senior Director, Worldwide Safety and Regulatory, Pfizer
Dr. Beverley Forsythe, Executive Director Patient Safety, Oncology TA, AstraZeneca
Dr. Christina Stroem Moeller, Executive Director, Global Safety, Amgen
Dr. Enrica Alteri, Head of Risk Management and Epidemiology, Global Drug Safety, Merck Serono
Dr. Celestina Arrigo, Senior Director, Pharmacovigilance Data Quality Expert, UCB Pharma
Dr. György Zörényi, Global Safety Physician, AstraZeneca
Dr. Julia Appelskog, Nordic Drug Safety Manager, Johnson & Johnson
Dr. Sumit Munjal, Consultant Physician, Johnson & Johnson
Dr. Rachna Kasliwal, Director Pharmacovigilance, Endocrinology, Ipsen BioPharma
Professor Liam Smeeth, Professor of Clinical Epidemiology, London School of Hygiene and Tropical Medicine
Dr. Brian Edwards, Principal Consultant, Pharmacovigilance and Drug Safety, NDA Regulatory Services
Dr. Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting
Philippa Guy, Associate Director, Head of Drug Safety and EU QPPV, 2Health
Carol Markwell, Director, Drug Safety Solutions
Driving the Industry Forward | www.futurepharmaus.com
Media Partners Organised By
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/pharmacovigilance

2. Conference Introduction
7th Annual Pharmacovigilance
30th - 31st January 2012, London, UK
Dear Colleague, Media Partners:
he importance of pharmacovigilance has been apparent since the problems
T PharmiWeb.com is the leading industry-sponsored portal for
with thalidomide emerged in the 1960s. Since then, various high profile drug the pharmaceutical sector. Supported by most of the leading
recalls, and estimations that more than 750,000 injuries and deaths each pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features,
year in the US are caused by adverse drug reactions, 1 have meant tightened events listings and international jobs to industry professionals across Europe and the US.
regulatory controls. For further information please email: corporate@pharmiweb.com
t is estimated that the average spend on pharmacovigilance is 6% to 13% of
I BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY
a company’s total R&D spend 2. From product development in clinical trials to WORLD. It is based and located in Warsaw, Poland.
post marketing surveillance, adverse drug reactions are monitored and safety
Biotechnology World was founded in 2007 to provide the world’s biotech and pharma
signals investigated.
information and market to make it universally accessible and useful for scientific
egulations and procedures are continually developing, with changes in EU
R and business processes. Its first step to fulfilling that mission was building the
legislation set for 2012. Such changes include plans to manage risk proactively, BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in
increase communication and transparency, and strengthen companies’ different channels. BIOTECHNOLOGY EUROPE offers companies completed internet
pharmacovigilance systems.
public relations, publication and marketing solutions. One of the mains goals of
isiongains 7th Annual Pharmacovigilance Conference will bring together
V BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to
industry experts to discuss current regulations, safety surveillance pre and post global biotechnology, pharmaceutical and life science activities.
marketing and review risk management plans to improve drug safety. For further information please visit: www.biotechnology-europe.com
By attending this conference you will: Future Pharmaceuticals has forged powerful relationships
Driving the Industry Forward | www.futurepharmaus.com
• ain insight into pharmacovigilance throughout the product lifecycle, from clinical
G with key industry leaders to provide a platform for successful
development to patient care brand recognition, and for senior decision-makers to have the means to procure and
• ean about pharmacoepidemiology and drug safety
L plan implementation strategies based on the topics covered. Positioned to be an
• ear about the pharmacovigilance activities in biopharmaceutical product
H authoritative resource within top pharma companies as well as small, specialty, and
development biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into
• valuate risk management plans for improving drug safety
E a highly targeted and responsive audience, bridging the gap between the industries’
top issues and the solutions top-tier vendors can provide.
• iscover the right benefit-risk balance
D For further information please visit: www.futurepharmaus.com
• earn about good pharmacovigilance practice through advances in audits and
L
inspections InPharm is the online platform for exclusive pharmaceutical
• eview the current and changing regulations in the EU, US and Asia
R news, comment, contracts, services, jobs and events and is
• nderstand how the role of the QPPV impacts patient safety
U home to InPharmjobs.com, Pharmafile and Pharmafocus.
For further information please visit: www.www.inpharm.com
• sses post marketing surveillance
A
• iscuss the current methods of reporting
D
• eview the use of Periodic Safety Update Reports (PSURs) post-authorisation for
R
safety signals
• xamine the principles of signal detection in pharmacovigilance
E Poster Presentation
• etwork with expert industry professionals to build new relationships
N At a busy conference it is hard to make sure everyone who shares your interests knows
I look forward to meeting you at the conference what you are doing. Maximise your time at Visiongain’s 7th Annual Pharmacovigilance
meeting by sharing your results in a poster presentation. With a plethora of key decision
Best regards makers, take advantage of this senior networking opportunity.
Please send your 200 word abstract, in English, to: info@visiongainglobal.com for
approval. The deadline for submissions is Monday 16th January, 2012. Please include
contact details for the corresponding author(s).
Academic institutions will not be charged a fee if booked as full-price delegates. Posters
Sarah Pilgrim submitted by pharmaceutical and biotechnology firms will be charged a fee of £199.
Conference Producer Posters submitted by service providers / vendors are welcome and will be subject to
evaluation. Upon approval a fee of £500 will apply. Two delegates from your organisation
must be booked at full price to present a poster.
Please note that all posters will be displayed at the discretion of Visiongain Ltd and are
Who will attend? subject to approval. Due to limited space, please register your interest early.
VP’s, Directors, Heads, Managers, Scientific Advisors, Consultants of:
Pharmacovigilance
Pharmacoepidemiology
Pharmacogenomics
Drug/Product Safety Sponsorship and exhibition opportunities
Drug Development
Information and Clinical Data Management This event offers a unique opportunity to meet and do business with some of the key
Clinical Pharmacology players in the pharmaceutical and biotech industries. If you have a service or product
Clinical Safety
Periodical safety update reports to promote, you can do so at this event by:
Risk Management • Hosting a networking drinks reception
Research & Development
Quality Assurance • Taking an exhibition space at the conference
Patient Safety • Advertising in the delegate documentation pack
Signal Detection • Providing branded bags, pens, gifts, etc.
Safety Surveillance
Outcomes Research If you would like more information on the range of sponsorship or exhibition
Data Analysis possibilities for visiongain's 7th Annual Pharmacovigilance Conference, please contact
Epidemiology
Medical Affairs us:
Regulatory Affairs and Compliance Damian Gorman, +44 (0)20 7549 9934
Information technology
Sales and Marketing damian.gorman@visiongainglobal.com
Visiongain report, Pharmacovigilance and Other Pharma Regulatory Developments 2010-2020
1
SCI article, http://www.soci.org/Chemistry-and-Industry/CnI-Data/2010/17/A-risky-business
2

3. Day 1
7th Annual Pharmacovigilance
Monday 30th January 2012
09:00 Registration and refreshments 12:40 Networking lunch
09:30 Opening address from the Chair 13:40 Do we understand the leverage of
pharmacoepidemiology on our patient safety
09:40 Pharmacovigilance throughout the product life cycle practice? – a safety physician’s point of view
– from clinical development to patient care • ignal generation or signal evaluation? Our experiences with
S
• egulatory compliance – expedited and periodic reporting
R pharmacoepidemiology (PE) safety studies in the post-marketing setting
• ntegrating signal detection using totality of information
I • valuation of external epidemiology signals coming from non-industrial
E
• mplementing proactive safety risk management
I studies- are we good enough to address them? Scientific and business
• nderstanding benefit-risk assessment and decision making
U aspects of a possible interaction with the academic field
• est practices for developing transparency with safety governance committees
B • eneration and evaluation of safety signals by designing in –house
G
PE studies Strength and limitations
Dr. Beverley Forsythe
Executive Director Patient Safety, Oncology TA • he hierarchy of evidence: randomised studies vs. epidemiology
T
AstraZeneca safety studies
• oncordance of quantitative safety signals and the results of
C
10:20 Pharmacovigilance activities in biopharmaceutical pharmacoepidemiology studies
product development • he future: a move from being “reactive” into being “proactive”. How to
T
• n overview into pharmacovigilance activities in biopharmaceutical
A overcome the possible internal and external hurdles?
product development, including case examples from two new to market Dr. György Zörényi
biological products Global Safety Physician
• ighlighting the differences with biopharma and long term safety
H AstraZeneca
• ooking at long term safety studies
L
Dr. Christina Stroem Moeller 14:20 Audits and good pharmacovigilance practice
Executive Director, Global Safety Dr. Celestina Arrigo
Amgen Senior Director, Pharmacovigilance Data Quality Expert
UCB Pharma
11:00 Morning refreshments
15:00 Afternoon Refreshments
11:20 Safety of biosimilars
• Safety data requirements and pharmacovigilance issues 15:20 Sponsor Spotlight Session
• RMPs and post approval studies T
ake this unique opportunity to be a part of the conference theme, network,
• Known and potential safety issues share ideas and provide an overview of your product/services to the audience.
• Current and future problems For more information please contact damian.gorman@visiongainglobal.com
Dr. Sandy Eisen
Chief Medical Officer 16:00 Pharmacovigilance audits / inspections
Frontline Pharma Consulting • urpose, remit and scope
P
• aking a risk based approach
T
12:00 Randomised evaluations utilising electronic health • racticalities and challenges
P
records to measure benefits and risks
• aximising the benefit / learning across audits
M
• ide agreement that we need better methods to assess the beneficial
W
and adverse effects of drugs in everyday practice • ommon findings
C
• his could be achieved with large scale simple randomised trials
T • mpact of new regulations
I
embedded in clinical practice Philippa Guy
• linicians often face genuine clinical uncertainty with therapeutic choices
C Head of Drug Safety and EU QPPV
made in a quasi-random way 2Heatlh
• ormal randomisation could usefully exploit this uncertainty to provide
F
evidence to guide practice
• he increasing use of computerised health records might allow us to
T 16:40 Closing remarks from the Chair
mount such trials through prospective randomising of patients with
subsequent data collection and follow up undertaken electronically
• he talk will present the case for such trials, discuss the barriers to their
T
implementation and how such barriers might be overcome 16:50 Networking drinks
Professor Liam Smeeth Take your discussions further and build new
Professor of Clinical Epidemiology relationships in a relaxed and informal setting
London School of Hygiene and Tropical Medicine
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011

4. Day 2
7th Annual Pharmacovigilance
Tuesday 31st January 2012
09:00 Registration and refreshments 12:40 Networking lunch
09:30 Opening address from the Chair 13:40 Post marketing surveillance and reporting of ADRs:
what’s new?
09:40 Special problems of pharmacovigilance for • mpact of new proposed legislation
I
generic products
• eterogeneity of data sources
H
• ith the current search for new business models, many big pharma are
W
energetically exploring and pursuing the generics market. • vidence for good quality processes
E
• e often find there are all sorts of special circumstances that arise, and
W • ustomisation of training on the human factor
C
there often isn’t the expertise in house to deal with them.
• lace of continuous improvement
P
• hat is the importance of the pharmacovigilance agreement if there’s a
W
partner company involved? • ole of EU QPPV in driving policy and setting standards
R
• hat does a risk management plan for a generic compound look like?
W Dr. Brian Edwards
Dr. Phillip Eichorn Principal Consultant, Pharmacovigilance & Drug Safety
Senior Director Worldwide Safety and Regulatory NDA Regulatory Services
Pfizer
14:20 Methods in post-marketing drug safety surveillance
10:20 Effective risk management plan – practical • pontaneous reporting and drug registries
S
approaches to maximise patient safety
• rescription event monitoring (PEM)
P
• ew requirements for risk management in pharma package
N
• ow to design a robust and comprehensive risk management plan
H • atabase related studies
D
• xecuting a risk management plan that incorporates developmental,
E Dr. Rachna Kasliwal
clinical and epidemiological safety data combined with post market Director Pharmacovigilance, Endocrinology
surveillance to ensure product safety Ipsen BioPharma
• valuating pharmacovigilance activities to characterise the potential or
E
identified risks in a timely defined manner; importance of additional risk 15:00 Afternoon refreshments
minimisation activities
• nsuring effective risk management throughout the full product lifecycle
E 15:20 Sponsor Spotlight Session
• ommunicating safety and comparative benefit/risk to health care
C T
ake this unique opportunity to be a part of the conference
professionals, patients and the public theme, network, share ideas and provide an overview of your
Dr. Julia Appelskog product/services to the audience. For more information please contact
Nordic Drug Safety Manager damian.gorman@visiongainglobal.com
Johnson & Johnson
16:00 PSURs– issues with content and submission
11:00 Morning refreshments • ommon inspection findings
C
11:20 From risk management to benefit-risk management: • ssessment reports
A
a paradigm shift • ork sharing and synchronisation
W
• mpact on drug development approach
I • lanned changes in Europe
P
• mpact on life-cycle management
I
Carol Markwell
• mpact on companies’ processes
I Director
• eeting patients’ needs
M Drug Safety Solutions
Dr. Enrica Alteri
Head Risk Management & Epidemiology, Global Drug Safety
Merck Serono 16:40 Closing remarks from the Chair
12:00 Benefit-risk assessment in pharmacovigilance 16:50 End of Conference
• rinciples, methodology and finding ‘the balance’
P
• takeholders and risk management
S
• ew initiatives - EMA
N
Dr. Sumit Munjal
Consultant Physician – UK (Global) Pharmacovigilance
Johnson & Johnson

5. Registration Form
7th Annual Pharmacovigilance
30th - 31st January 2012, London, UK
Angel
Conf. code PP Pentonville Road
7th Annual
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Standard Prices
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Pharmacovigilance
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ad
Conference only Fee: £1299 VAT: £259.80 Total: £1558.80
30th - 31st January 2012 Old Street
Number of bookings: Total cost: Location: Visiongain Conference Centre Old Street
Address:
230 City Road
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Distribution of your company’s promotional literature to all conference attendees EC1V 2TT
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Forename: Surname: Email: piyush.patel@visiongain.com
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