1. 5th Annual
Pharmacovigilance
Implementing best practices in drug safety and surveillance
17th - 19th March 2010, BSG Conference Centre, London, UK BOOK NOW!
Key Speakers
Dr Rachel Sobel, Senior Director, Epidemiology - Specialty Care BU Group Head, Pfizer
Seema Jaitly, VP Global Medical & Scientific Affairs, Stiefel Laboratories, GSK
Dr John Parkinson, Director, General Practice Research Database (GPRD), MHRA
Dr John Talbot, Director - Patient Safety, Processes & Standards, AstraZeneca R&D
Professor Saad Shakir, Director, Drug Safety Research Unit
Dr Jacques Wodelet, Head of Quality Intelligence & Consultation, Merck-Serono, Geneva
Dr Irene Michas, Director, Pharmacovigilance Education and Process Documentation (PEPD), Pfizer
Paolo Biffignandi, Chief Medical Officer, EU Vigilance & President, TOPRA
Jim Weatherall, Global Lead, Biomedical Informatics, AstraZeneca
Dr K N Woodward, Head - Global Pharmacovigilance, Intervet - Schering-Plough Animal Health
Pre Conference workshop Wednesday 17th March 2010
Safety Data Exchange Agreements (SDEA) for licensed and unlicensed products
Led by: Emma Boulton, Global Head of Pharmacovigilance and Medical Information,EUSA Pharma,
and Lesley Deane, PhV Consultancy
Associate Sponsors
Driving the Industry Forward | www.futurepharmaus.com Organised By
Media Partners
To Book Call: +44 (0) 20 7336 6100 | http://www.visiongain.com/pv

2. Conference Introduction
5th Annual Pharmacovigilance Conference
17th -19th March 2010, London UK
Implementing best practices in drug safety and surveillance Associate Sponsors:
Pharmaceutical and biotechnology companies can now draw on the
expertise and resources of PrimeVigilance, a service provider that is
Dear Colleague, completely dedicated to compliant and cost-effective pharmacovigilance solutions, with a
harmacovigilance is becoming ever more critical for pharmaceutical companies as
P validated safety database, highly qualified and experienced operational staff, and leading
the public and legislative pressure to ensure drug safety increases every day. Effective expert consultants. PrimeVigilance fills the gap between the large multinational CROs that
implementation of pharmacovigilance can aid drug development, benefit rational do not provide a service specifically geared towards pharmacovigilance for small- and
communication and sound public understanding, taking emerging regulatory policies medium-sized companies, and the small service providers that do not have the critical mass,
worldwide into account. The challenge to manage adverse events in an optimal and
efficient way and, at the same time, adhere to regulatory requirements will demand a great expertise or wide international presence needed to reassure that patients and products will
emphasis on pharmacovigilance in the near future. be adequately protected.
isiongain’s 5th Annual Pharmacovigilance conference will discuss a range of key elements
V For further information please visit www.primevigilance.com
including the regulatory and legislative framework, PSUR, and risk mitigation strategies that
are vital for drug safety and surveillance. With succinct themes and interactive sessions by Media Partners:
key opinion leaders, the conference will bring latest insights, integrated strategies and best PharmiWeb.com is the leading industry-sponsored portal for the
practices in pharmacovigilance. pharmaceutical sector. Supported by most of the leading pharmaceutical
corporations, PharmiWeb.com provides dynamic real-time news, features, events listings
By attending this conference you will gain knowledge on: and international jobs to industry professionals across Europe and the US.
• valuation of risk mitigation activities: REMS and beyond from the
E For further information please email: corporate@pharmiweb.com
pharmacoepidemiologist’s perspective BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is
• egulatory focus on evaluation of risk mitigation strategies, contrasting the FDAAA,
R based and located in Warsaw, Poland. Biotechnology World was founded
REMS and the EU-RMP in 2007 to provide the world’s biotech and pharma information and market to make it
universally accessible and useful for scientific and business processes. Its first step to fulfilling
• lassification of Adverse drug reactions by mechanism (the EIDOS system) and by
C
clinical presentation (the DoTS system) that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick
spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies
• Pharmacovigilance in clinical trials of investigational medicinal products completed internet public relations, publication and marketing solutions. One of the mains
• New Horizons: Proposals from the EU Commission “Pharma Package” goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe
• eveloping and implementing training programs for global pharmacovigilance
D to global biotechnology, pharmaceutical and life science activities.
systems, bridging geographies and requirements For further information please visit www.biotechnology-europe.com
Future Pharmaceuticals has forged powerful relationships with key industry
Driving the Industry Forward | www.futurepharmaus.com
• evelopment Safety Update Report (DSUR): Harmonising periodic safety reporting
D leaders to provide a platform for successful brand recognition, and for
during clinical trials
senior decision-makers to have the means to procure and plan implementation strategies
• pplication of text analytics to the surveillance of published literature
A based on the topics covered. Positioned to be an authoritative resource within top pharma
• Pharmacovigilance in early phase oncology trials (Phase I & II) companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared
to create a deep penetration into a highly targeted and responsive audience, bridging the gap
• Implementing inspection readiness program as a guide to maximise readiness
between the industries’ top issues and the solutions top-tier vendors can provide.
• rug safety investigation – Pre and Post Marketing
D For further information please visit: www.futurepharmaus.com
InPharm is the online platform for exclusive pharmaceutical news, comment,
contracts, services, jobs and events and is home to InPharmjobs.com,
Pharmafile and Pharmafocus.
Maninder Paul For further information please visit: www.In-Pharm.com
Conference Producer ‘Pharma Connections Worldwide® is the leading professional business
networking website focused in the Pharmaceutical, Biotechnology and
Life Sciences research industry. Our goal is to provide a conduit for delivery of premiere content
coupled with the right clientele in order to facilitate business development opportunities among
industry professionals responsible for making key decisions in a global marketplace. ‘
Target Audience For further information please visit www.pharmaconnections.com
Pharmaceutical and Biotechnological Companies
Contract Manufacturing Organisations (CMOs)
Drug Regulators, Intellectual Property/Law Firms
Academia, Government Bodies, Regulatory Affairs
Sponsorship and exhibition opportunities:
Who should attend? This event offers a unique opportunity to meet and do business with some of the key
VP’s, Directors, Managers, Scientific Advisors, Consultants of:
players in the pharmaceutical and biotech industries. If you have a service or product to
• Pharmacovigilance • Quality Assurance
promote, you can do so at this event by:
• Pharmacoepidemiology • QPPV
• Hosting a networking drinks reception
• Pharmacogenomics • Patient Safety/ Surveillance
• Taking an exhibition space at the conference
• Drug/Product Safety • Signal Detection
• Advertising in the delegate documentation pack
• Drug Development • Outcomes Research
• Providing branded bags, pens, gifts, etc.
• Information and Clinical Data • Data Analysis
Management If you would like more information on the range of sponsorship or exhibition possibilities for
• Epidemiology
• Clinical Pharmacology visiongain's 5th Annual Pharmacovigilance Conference, please contact us:
• Toxicology
• Clinical Safety Ronald Magali, +44 (0)20 7549 9934
• Medical Affairs
• PSUR ronald.magali@visiongainglobal.com
• Regulatory Affairs and
• Risk Management Compliance Christopher Clegg, +44 (0)20 7549 9943
• Research & Development • Sales & Marketing christopher.clegg@visiongainglobal.com

3. Pre-Conference Interactive Workshop
5th Annual Pharmacovigilance Conference
Wednesday 17th March 2010
Safety Data Exchange Agreements (SDEA) for
licensed and unlicensed products
Led by: Emma Boulton Lesley Deane Timings: 9:30 - 10:00 Coffee & Registration
0
Global Head of Pharmacovigilance and 10:00 - 17:00 Workshop
Medical Information and Deputy EU QPPV PhV Consultancy T
iming includes lunch and refreshment breaks
EUSA Pharma
Key Topics: About your workshop leaders:
During this one day workshop we will explore the Safety Data Emma Boulton is currently the Global Head of Pharmacovigilance
Exchange Agreements (SDEA) for licensed and unlicensed and Medical Information and Deputy EU QPPV at EUSA Pharma.
products and how these are scrutinised by competent authority Emma has 14 years experience in various drug safety roles in both
inspectors. This workshop will be an interactive and collaborative the pharma industry and CRO.
forum and help you achieve a thorough understanding on the
following themes:
• Safety Data Exchange Agreements (SDEA) for licensed
EUSA Pharma is a specialty pharmaceutical company with a
and unlicensed products i.e. those provided on a named
strong and growing portfolio of specialised hospital medicines
patent basis
focused on oncology, pain control and critical care, which it
o Strategies for clear SDEA to ensure that all parties
markets predominantly in Europe and the US (as the company’s
know what their responsibilities are
name suggests) through a network of EUSA affiliates and
• Impact of acquisition and divestment of products or distributors.
companies on the pharmacovigilance system For more information http://www.eusapharma.com/
o Careful management of acquisition of a company
Lesley Deane set-up a pharmacovigilance consultancy company
or product to ensure transition and merger into the
specialising in pharmacovigilance audits and preparing companies
current pharmacovigilance system
for competent authority inspections in 1997. Lesley has over
o Implementation of divestment of products from 20 years experience in the pharmaceutical industry, specific to
the portfolio needs to ensure that all safety data is pharmacovigilance and regulatory affairs, and membership to
transferred from one MAH to another PIPA, BARQA and the British Institute of Regulatory Affairs.
For more information http://www.phvconsultancy.com/

4. Day 1
5th Annual Pharmacovigilance Conference
Thursday 18th March 2010
09:30 Registration and refreshments 13:10 Networking lunch
14:30 Meta-analysis for safety
10:00 Opening address from the chair • Principles and regulatory guidance
• Addressing pre-approval signals
• Addressing post-approval signals
10:10 Evaluation of risk mitigation activities: REMS • Case examples and challenges
and beyond from the pharmacoepidemiologist’s Dr Nawab Qizilbash
perspective Director, OXON Epidemiology
Honorary Senior Lecturer, Imperial College, London University
• harmacoepidemiologist’s role in risk management & pharmacovigilance
P
• ummarise the increased regulatory focus on evaluation of risk mitigation
S 15:10 Developing and implementing training programs
strategies, contrasting the EU & US legislation on risk mitigation for global pharmacovigilance systems, bridging
evaluation (i.e. FDAAA, REMS and the EU-RMP) geographies and requirements
• Case examples and current challenges to implementation • hallenges in developing and implementing a global PV training program:
C
A case example
Dr Rachel Sobel
• ow does one meet diverse customer training needs in a dynamic and
H
Senior Director, Epidemiology - Specialty Care BU Group Head
highly regulated environment?
Pfizer
• lended learning approaches: How to make the most of self-study,
B
interactive e-learning and instructor led training?
10:50 Approaching risk management through classification • olutions for global implementation: What tools can be
S
of adverse drug reactions used for remote training?
Dr Irene Michas
• dentification of those at risk of adverse drug reactions
I Director, Pharmacovigilance Education and
involves: knowledge of susceptibilities; availability of monitoring Process Documentation (PEPD)
techniques; availability of protective techniques; the benefit: harm balance Pfizer
• Adverse drug reactions can be classified by mechanism (the EIDOS
system) and by clinical presentation (the DoTS system) 15:50 Afternoon refreshments
• lassification of Adverse drug reactions by mechanism (the EIDOS system)
C 16:10 Quantitative safety signal detection: CIOMS
and by clinical presentation (the DoTS system) Working Group VIII
Prof Jeffrey Aronson • verview of different quantitative methods being applied to safety
O
Reader in Clinical Pharmacology, University of Oxford databases to detect potential safety signals
Immediate Past-President, British Pharmacological Society • ntroduction to the concept of an ‘Observation of Disproportional Reporting’
I
• ntegration of quantitative methods and traditional qualitative methods
I
into a signal detection program, including management of information
11:30 Morning refreshments
generated by a signal detection program
Paul Dolin
11:50 Guidelines on risk management systems for Head
medicinal products for human use European Drug Safety
• U guidelines on risk management plans - completion, data aspects,
E 16:50 Application of text analytics to the surveillance of
different product types published literature
• RiskMAPs - FDAAA guidance, new regulations, impact for the US • utline of fundamental challenges for conducting routine post-marketing
O
surveillance on the published literature
• oW - What are the requirements and where is this heading in the rest
R
• xplain why the utilisation of informatics approaches such as text analytics
E
of the world?
potentially address some of these challenges
Seema Jaitly • iscuss the success of an agile internal project in delivering a system to
D
VP Global Medical & Scientific Affairs employ such an approach within 6 months
Stiefel Laboratories, GSK • Overview on the business impact of the new system so far
• ooking ahead: Future enhancements and alternative applications of
L
the approach
12:30 Regulatory affairs: Pharmacovigilance in Europe
Jim Weatherall
• egulatory affairs: Pharmacovigilance in Europe
R Global Lead, Biomedical Informatics
• The EUDRA vigilance system AstraZeneca
• N w Horizons: Proposals from the EU Commission “Pharma Package”
e
17:30 Closing remarks from the chair
Paolo Biffignandi
Chief Medical Officer, EU Vigilance &
17:35 Networking drinks
President, TOPRA
Take your discussions further and build new
relationships in a relaxed and informal setting.
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2009

5. Day 2
5th Annual Pharmacovigilance Conference
Friday 19th March 2009, 2009
09:30 Registration and refreshments 14:30 Pharmacovigilance in clinical trials of investigational
medicinal products
10:00 Opening address from the chair • Strategy and practicalities for collection of safety data
• isk management in clinical trials
R
10:10 New strategy: Proactive approach towards
• Use of Data Monitoring Committees (DMC)
inspections
• nalysis and presentation of safety data
A
• Inspection objectives
Dr John Talbot
• Graphic thinking Director - Patient Safety, Processes & Standards
• isual thinking & process mapping
V AstraZeneca R&D
• echnical & financial aspects to set-up a visual thinking – process mapping
T
approach 15:10 Development Safety Update Report (DSUR):
• nspection readiness program as a guide to maximize readiness
I Harmonising periodic safety reporting during
• uick demo of the tool
Q clinical trials
r Jacques Wodelet
D • CIOMS VII initiative and ICH E2F - Where are we now?
Head of Quality Intelligence & Consultation
• DSUR content - What is new compared to Annual Safety Reports (ASRs)?
Merck-Serono, Geneva
• se of DSUR to identify and assess risks in clinical trial subjects - Cross-
U
talk with other safety regulatory documents
10:50 The contributions of the researcher to safety
Pilar Carrero
specification and risk management Team Leader Safety Medical Writing
• houghts about how to plan safety specification
T Novo Nordisk
• ow can drug utilisation studies support risk management
H
• Reporting cycle for PSURs of registered products 15:50 Afternoon refreshments
• tudies to address potential risk, identified risk and missing information
S
• How to monitor risk management 16:10 Pharmacovigilance in early phase oncology trials
Prof Saad Shakir – A case study
Director
• Phase I and Phase II trials
Drug Safety Research Unit
• rial document development (PIS/protocols/IBs)
T
11:30 Morning refreshments • ngoing safety review and involvement in critical decisions (e.g. dose
O
escalation)
11:50 Drug safety investigation – Pre and Post Marketing • Writing of Annual Safety Reports (ASRs)
• egulatory – Requirements and strategic consideration
R Ben Jefferies
Pharmacovigilance Scientist
• ignal generation – Case investigation, trials, spontaneous events,
S
Cancer Research UK
databases, data mining
• ignal investigation – Study designs and resources
S
• Comparison of methods used at different stages of drug development 16:50 Veterinary pharmacovigilance and human health
Dr William C Maier • iscuss how veterinary pharmacovigilance extends to animal health,
D
Vice President, Epidemiology/Drug Safety/Risk Management environmental adverse effects, safety of veterinary residues in human
Registrat-Mapi food and human safety
• ”Human adverse reaction” following exposure to a veterinary medicine
12:30 Pharmacovigilance - Maximising the potential: • Global legislation to deal with veterinary pharmacovigilance
Data is king Dr K N Woodward
• Geographic and population cover of data
Head - Global Pharmacovigilance
Intervet, Schering-Plough Animal Health
• uality of data
Q
• Outputs - Relative or absolute?
• The right data for the right purpose
17:30 Chair’s closing remarks
Dr John Parkinson
Director, General Practice Research Database (GPRD)
MHRA 17:40 End of conference
13:10 Networking lunch

6. Registration Form
5th Annual Pharmacovigilance Conference
17th -19th March 2010, London UK
Angel
For multiple bookings Pentonville Road
Photocopy this form Conf. code TS 5th Annual Pharmacovilgilance
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17th – 19th March 2010
Conference and workshop Fee: £1699 VAT: £254.85 Total: £1953.85 Old Street
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