1. 3rd
Pharmacovigilance
Pharmacovigilance
&
Risk
Management
Strategies:
New
Advances
June
17-­‐18,
Cumberland
Hotel,
UK
Pharmacovigilance & Risk Management Strategies: New Advances
17th – 18th June 2014, Cumberland Hotel, UK BOOK NOW!
KeySpeakers
• Dr
Humaira
Qureshi,
VP
Pharmacovigilance
Outsourcing,
Kinapse
• Dr
Anil
Dhiri,
DVM
MBA,
Consultant
Business
Analyst,
Oracle
• Dr
Philip
Jones,
Associate
Director
&
Deputy
QPPV,
Symogen
• Dr
Nawab
Qizilbash,
Head,
OXON
Epidemiology
• Dr
Simon
Ingate,
Principal
Consultant,
Pope
Woodhead
• Dr
Julia
Appelskog,
EU
QPPV,
Bluefish
Pharmaceutical
Groups
• Dr
Sumit
Manjal,
Director
of
Pharmacovigilance,
Takeda
• Dr
David
Williams
,
CEO,
Medical
Affairs
• Dr
Philip
Eichorn,
Senior
Director,
Pfizer
• Dr
Bert
van
Leeuwen,
Deputy
QPPV,
Astellas
Pharma
• Dr
Derek
Woodcock,
Pharma
Consultant,
Sarah
Cannon
Research
Institute
(SCRI)
• Dr
Steinar
Madsen,
Medical
Director,
Norwegian
Medicines
Agency
• Dr
Fiona
Maini,
Senior
Manager,
Deloitte
Consulting
• Dr
Anthony
Leese,
Manager,
Deloitte
Consulting
• Dr
Lisa
Chamberlain
James
,
Senior
Partner
,
Trilogy
Writing
&
Consulting
GmbH
• Dr
Virgilio
Vinas,
Medical
Adviser
Pharmacovigilance,
FDA,
EMA,
DvM
• Dr
Amanda
Sibley,
Global
Head
of
Safety
Services,
Product
Life
Group
Media Partners
Driving the Industry Forward www.futurepharmaus.com
To book please contact +44 (0)207 074 0089 or online: http://www.appelconsulting.co.uk/services/products

2. Day 1
Day 1
09:00 Registration and refreshments
09:30 Opening address from the chair
Dr Humaira Qureshi
VP Pharmacovigilance
Kinapse
09:40 Current challenges facing the
pharmacovigilance industry
• Transitioning to new RPM
• Approaching the new template
• Managing the resource under the new requirements
Dr Philip Eichorn
Deputy Senior Director
Pfizer
10:20 Effective Safety Communication
• Introduction to crisis and emergency risk communication
• Risk realities and risk perception
• Communicating safety information to patients and healthcare professionals
Dr Julia Appelskog
Director& QPPV
Bluefish
Pharmaceuticals
Group
11:00 Morning refreshments
11:20 Pharmacovigilance: Contribution Towards
Corporate Development
• Pharmacovigilance metrics/ KPI’s
• Pharmacovigilance Contribution towards patient safety
• Pharmacoviliance as a business model
Dr Philip Jones
Associate Director & Deputy QPPV
Symogen
12:00 DataIntegrationforSafety
• Need for & types of data integration
• Trials versus epidemiological studies
• ENCePP discussions at the EMA
DrNawabQizilbash
Head
OXONEpidemiology
12:40 Networking lunch
13.40 Signal detection & risk management:
strategies to leverage patient safety
• New Aspects to signal detection
• Impact of signal detection on risk management
• Practical considerations with risk management plans
Dr Amanda Sibley
Global Head of Safety Services
Product Life Group
14:20 Integrating Clinical Safety & Spontaneous Reporting
• Challenges for System integration
• Optimism business processes
• RegulatoryChallenges
Dr Anil Dhiri
Consultant Business Analyst
Oracle
15:00 Afternoon refreshments
15:20 PSMF practical points to consider
• Format maintenance and review
• Potential Usefulness and Audits and Inspections
• Practical Considerations
Derek
Woodcock
Pharma
Consultant
(SCRI)
16:00 Closing remarks from the chair
16:10 Networking drinks
Takeyour discussions further and build new
relationships in a relaxed and informal setting.

3. Day 2
Day 2
09:00 Registration and refreshments
09:30 Opening address from the chair
09:40 Case Evaluation and labeling impact
• Case Medical Evaluation
• Established Safety Profile
• Drug Safety Committee
Virgilio Vinas
MedicalAdvisor Scientific Pharmacoviglance
FDA, EMA, DvM
10:20 Quality Assurance within PV
• The requirements of PV legislation
• QA system set up
• Metrics and KPIs
Humaira Qureshi
VP, Pharmacovigilance Outsourcing
Kinapse
11:00 Morning refreshments
11:20 Good Pharmacovigilance in Practice
• A retrospective and practical experiences of GVP
• Industry Challenges and Lessons learnt
• Preparing for future change
Dr Fiona Miani
Senior Director
Deloitte
12:00 Real time minimization effectiveness
evaluation
• Traditional risk communications are hard to evaluate
• Web-based tools offer interactivity & real-time effectiveness
measurement
• A short demonstration of RM tool use and effectiveness metrics
Dr Simon Ingate
Principal Consultant
Pope Woodhead
12:40 Networking lunch
13:40 Quality of Data, new business rules to create a more
solid base for data mining and statistics
•Newtechniquesindataminingandstatistics
• Data-mininganalyses ofpharmacovigilancesignalsinrelation torelevant
comparison drugs
• Governance and the management process
Dr Steiner Madsen
MedicalDirector
Norwegian medicines Agency
14:20 Big Data to analyze trends and understand
pharmacoepidemiology
• The challenge of big data analysis
• Staying ahead in signal detection
• Decision making in real time
Dr David Williams , CEO, Medical Affairs
15:00 Afternoon refreshments
15:20 The future of pharmacovigilance within industry
Our expert panel will discuss and debate on the future and progression of
pharmacovigilance opportunities and operational challenges to working
environments
Panel members will be drawn from the speakers who take part on day
one or day two.
Dr Humaira Qureshi
VP Pharmacovigilanc
Kinapse
Sumit Munjal
Director pharmacovigilance
Takeda
Lisa Chamberlain James
Senior Partner
Trilogy Writing & Consulting
16:40 Chair’s closing remarks
16:50 Endof conference

4. Registration Form
June 17-18 LONDON UK
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