3rd_final_pharmacovigilance----_draft_agenda__2010-9-10-1 copy-1-1-1-1-1
TRANSCRIPT
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!
Key Speakers
• 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
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 Data Integration for Safety
• Need for & types of data integration
• Trials versus epidemiological studies
• ENCePP discussions at the EMA
Dr Nawab Qizilbash Head OXON Epidemiology
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
• Regulatory Challenges
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
Take your discussions further and build new relationships in a relaxed and informal setting.
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 Medical Advisor 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
• Newtechniquesindata miningandstatistics
• Data-mining analyses of pharmacovigilance signals in relation to relevant comparison drugs
• Governance and the management process
Dr Steiner Madsen Medical Director 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 End of conference
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June 17-18 LONDON UK
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