1. 6th Annual
Pharmacovigilance
Examining latest developments in pharmacovigilance, drug safety and risk
management to ensure safer drugs to market
16th - 17th March 2011, Thistle City Barbican, London, UK BOOK NOW!
Key Speakers
Dr. Doris I. Stenver, Chief Medical Officer EU Pharmacovigilance, Working Party Delegate, Danish Medicines Agency
Dr. William Gregory, Senior Director, Safety & Risk Management, Pfizer
Dr. Sandip Chaudhuri, Director and Safety Risk Management Lead, Pfizer
Dr. Vicki Edwards, Director, European Pharmacovigilance, Abbott Laboratories
Rashmi Hegde, Director Pharmacovigilance, Abbott Products
Dr. Ute Hoeffner, EU QPPV, Novartis Consumer Health GmbH
Dr. Julia Appelskog, Drug Safety Manager, Johnson & Johnson
Sandeep Bhat, Global Director, Life Sciences and Solutions Head, Matured Markets, MphasiS an HP
Dr. Sumit Munjal ,Consultant Physician - UK (Global) Pharmacovigilance, Johnson & Johnson
Dr. William C Maier, Vice President, Epidemiology/Drug Safety/Risk Management, Registrat-Mapi
Rishi Kiran Chopra, Senior Safety Advisor, GlaxoSmithKline
Dr. Anil K Dhiri, Senior Consulting Technical Manager, Oracle Health Sciences
Véronique Basch, Executive Director, Safety Europe, United Biosource Corporation
Paul Murphy, Healthcare Business Manager, Gael Ltd
Associate Sponsor
Driving the Industry Forward | www.futurepharmaus.com Organised By
Media Partners
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/pharmacovigilance

2. Conference Introduction
6th Annual Pharmacovigilance
16th - 17th March 2011, London, UK
Dear Colleague, Associate Sponsor:
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isiongain’s 6th Annual Pharmacovigilance Conference is designed to bring together
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exclusive panel of experts who will discuss various aspects of pharmacovigilance practices
in clinical trails, risk management and drug safety. The conference will feature keynote Media Partners:
addresses on reporting, auditing & inspection, technical advances for the betterment of PharmiWeb.com is the leading industry-sponsored portal for
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pharmacovigilance, attending this conference will enable you to:
and the US.
• ain insight about the global pharmacovigilance landscape today and perspectives
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on the future
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• Understand pharmacovigilance during the pre-approval phases BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY
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• Learn signal detection methodologies to support effective safety management public relations, publication and marketing solutions. One of the mains goals of
BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to
• Make the most of inspections and best practices in maintaining constant vigilance global biotechnology, pharmaceutical and life science activities.
• eview current principles and practices of regulatory pharmacovigilace in Europe and US
R For further information please visit: www.biotechnology-europe.com
• Improve pharmacovigilance in Asia
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• tay ahead by learning advances in computing and electronic communications in
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I look forward to meeting you at the conference
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InPharm is the online platform for exclusive pharmaceutical
news, comment, contracts, services, jobs and events and is
home to InPharmjobs.com, Pharmafile and Pharmafocus.
Sonia Tomar For further information please visit: www.In-Pharm.com
Conference Producer
Who will attend? Sponsorship and exhibition opportunities
VP’s, Directors, Heads, Managers, Scientific Advisors, Consultants of:
• Pharmacovigilance This event offers a unique opportunity to meet and do business with some
• Pharmacoepidemiology of the key players in the pharmaceutical and biotech industries. If you have
• Pharmacogenomics
• Drug/Product Safety a service or product to promote, you can do so at this event by:
• Drug Development
• Information and Clinical Data Management • Hosting a networking drinks reception
• Clinical Pharmacology
• Clinical Safety • Taking an exhibition space at the conference
• Periodical safety update report
• Risk Management • Advertising in the delegate documentation pack
• Research & Development
• Quality Assurance • Providing branded bags, pens, gifts, etc.
• Patient Safety
• Signal Detection If you would like more information on the range of sponsorship or exhibition
• Safety Surveillance
• Outcomes Research
possibilities for visiongain's 6th Annual Pharmacovigilance Conference, please
• Data Analysis contact us:
• Epidemiology
• Medical Affairs Ronald Magali, +44 (0)20 7549 9934
• Regulatory Affairs and Compliance
• Information technology ronald.magali@visiongainglobal.com
• Sales and Marketing
1
Gold Sheet, a trade publication on drug quality that analyzes FDA data.
2
Visiongain report: Pharmacovigilance and Other Pharma Regulatory Developments 2010-2020

3. Day 1
6th Annual Pharmacovigilance
Wednesday 16th March 2011
09:00 Registration and refreshments 14:20 Benefit/Risk assessments and striking the right balance
• Developing systems in harmony with regulatory developments
09:30 Opening address from the chair • aintaining constant vigilance and making the best pre and post
M
marketing safety judgements
09:40 The global pharmacovigilance landscape today
• aking accurate determinations of whether a product is in fact safe and
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and perspectives on the future what can alter the determinations
T
oday we have unprecedented opportunities to understand emerging
Dr. Sandip Chaudhuri
profiles of biopharaceutical products; early understanding keeps patient
Director and Safety Risk Management Lead
safety as the highest priority and at the same time facilitates access to
Pfizer
medicines by patients who need them. This session will provide perspectives
on some of the emerging trends in global pharmacovigilance:
15:00 Afternoon Refreshments
• How have ICH and CIOMS set the stage?
• o more digitised data and new controlled vocabularies inform or add
D 15:20 Discover the benefits of using an electronic
more hay? Quality Management System (QMS) within
• Are there global implications of the new EU legislation?
Pharmacovigilance
Dr. William Gregory T
o illustrate the benefits of an electronic QMS for the Pharmacovigilance
Senior Director, Safety & Risk Management sector, and to demonstrate how the effective management of your
Pfizer compliance processes can turn into a business benefit.
10:20 Audit and Inspection • lectronic QMS ‘v’ Manual System - why should you migrate to an
E
• Making most of inspections electronic version?
• Best practices in maintaining constant vigilance • nalysis & Feedback on Compliance processes - how can it help staff and
A
Senior Management?
Dr. Vicki Edwards
• Ensuring Quality is organisation wide - why and how can this happen?
Director, European Pharmacovigilance
• chieving and maintaining compliance with industry standards/
A
Abbott Laboratories
regulations - how and why an electronic QMS is more cost effective
11:00 Morning refreshments and efficient
Paul Murphy
11:20 Pharmacovigilance during the pre-approval phases: Healthcare Business Manager
an evolving pharmaceutical industry model Gael Ltd
• Pharmacovigilance during pre clinical trails
• Practical pharmacovigilance analysis strategies 15:40 Principles of signal detection
• redicting the clinical relevance of drug interactions from pre-approval studies
P Signals have qualitative and quantitative aspects:
• Methodological aspects of quantitative signal detection
12:00 Key transition between pre and post marketing • Role and approach to qualitative signal detection
safety in the EU D
ifferent categories of adverse effects need different methods for detection
P
eri-approval transition time is key in pharmacovigilance for a smooth C
urrent pharmacovigilance is predominantly based on spontaneous
transition. Activities include the preparation of documents to be provided reporting and is mainly helpful in detecting
together with the application, but also strong planning and preparation • ype B effects (usually unrelated to dosage, serious, unexpected
T
of the post marketing safety system and operations. Challenges remain and unpredictable)
especially for companies performing this transition for the first time. • nusual Type A effects (related to the pharmacological effects and
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The presentation will focus on: are dosage- related)
• Risk Management Plan E
mploy data mining techniques to analyse large volumes of adverse
• Company Core Safety Information event report data
• Detailed Description of the PV System Other sources of signals:
• QPPV role at transition time • prescription event monitoring
• Post marketing documents and activities: getting operations ready • large automated data resources
Véronique Basch • patient registries
Executive Director, Safety Europe • Case-control surveillance and follow-up studies
United Biosource Corporation Outline of limitations of methodology and data
K
ey messages from the european medicines agency guideline on the uses of
12:40 Networking lunch statistical signal detection methods in the eudravigilance data analysis system
13:40 Risk management plans: are they a tool for Dr. Anila Verma
Director-Drug Safety & Pharmacoepidemiology
improving drug safety?
Amgen
• RMP for an OTC drug - a contradiction?
• RMP upon request of a Health Authority – Who needs to be informed
16:20 Closing remarks from the chair
• Process within the Company, departments involved and responsibilities
• Evaluation and assessment of risk minimisation
Dr. Ute Hoeffner
EU QPPV 16:50 Networking drinks
Novartis Consumer Health GmbH 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, 2011

4. Day 2
6th Annual Pharmacovigilance
Thursday 17th March 2011
09:00 Registration and refreshments 13:40 Improving Pharmacovigilance in Asia
• Current status of Asia Pacific regulations relating to Pharmacovigilance
09:30 Opening address from the chair • mportant insights on rapidly evolving Pharmacovigilance regulations
I
in these markets
• ole of Harmonisation in Asian Pharmacovigilance regulations
R
09:40 Strategies to improve pharmacovigilance practices
• trategic challenges in the evolution of Asian Pharmacovigilance
S
• Societal trends with impact on pharmacovigilance
regulations in next decades
• New pharmacovigilance legislation
Rashmi Hegde
• Communication and transparency Director Pharmacovigilance, Asia-Middle East-Australia-Canada
• Stakeholder involvement Abbott Products
Dr. Doris I. Stenver
Chief Medical Officer, EU Pharmacovigilance Working Party Delegate 14:20 Advances in computing and electronic
Danish Medicines Agency communications in pharmacovigilance
Configurable of the Shelf (COTs) vs Customised
10:20 Pharmacovigilance of biopharmaceuticals: • Implication of ICH E2BR3(HL7)
challenges remain • Software as Service (SaaS)
• The importance of pharmacovigilance of biopharmaceuticals • Electronic Health Record
• Challenges to ADR processing during postmarketing and clinical trials • Signals and Data Mining
• Unique aspects of safety concerns T
he presentation will focus on software selection, emerging standards
• To be prepared for the unexpected and importance of electronic health records for signals and data mining.
Additionally, the idea of a “Clearing House” for single case management
Dr. Julia Appelskog
will be floated
Drug Safety Manager
Johnson & Johnson Dr. Anil K Dhiri
Senior Consulting Technical Manager, Oracle Health Sciences
GBU Consulting
11:00 Morning refreshments
15:00 Afternoon refreshments
11:20 Regulatory Pharmacovigilace in Europe current
principles and practice
15:20 The Internet and drug safety: what are the
• uropean Medicines Agency and National competent authorities - role in
E implications for pharmacovigilance?
European Pharmacovigilance
H
ow many use the internet / smart phones / Social Media (S.M),
• ey responsibilities of Committee for Medicinal Products for Human Use
K
and how many access manufacturer information through these
(CHMP) and Pharmacovigilance Working Party (PhVWP)
platforms, how many are pro-digital, anti-digital or not sure)
• arketing authorisation procedures – Centralised/Decentralised/Mutual-
M
• The social media age
recognition/National
• New initiatives • The pharma social media debate
Dr. Sumit Munjal • The implications for pharmacovigilance
Consultant Physician - UK (Global) Pharmacovigilance
• The future of social media in pharma
Johnson & Johnson
Rishi Kiran Chopra
Senior Safety Advisor
12:00 New EU Pharmacovigilance and Risk Management GlaxoSmithKline
Laws in Europe: What you need to do to prepare
• Imminent changes to PV and Risk Management Laws in EU – detail 16:00 Social media consideration within pharmacovigilance
• Likely Impact on Pharmaceutical Companies Dr. Sandeep Bhat
• hat you need to do now and in the future to thrive in the new environment
W Director, Life Sciences
Hewlett-Packard
Dr. William C Maier
Vice President, Epidemiology/Drug Safety/Risk Management
Registrat-Mapi 16:40 Chair’s closing remarks
12:40 Networking lunch 16:50 End of Conference

5. Registration Form
6th Annual Pharmacovigilance
16th - 17th March 2011, London, UK
For multiple bookings
Photocopy this form Conf. code VG 6th Annual
Pharmacovigilance
Standard Prices
16th - 17th March 2011
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