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Day one - Wednesday 17 September 2008
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7.30am | Registration & coffee
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8.50am | Opening remarks from the chair
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| INTERNATIONAL DRUG SAFETY LANDSCAPE |
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9am | Next generation pharmacovigilance: an industry perspective
- Innovation in pharmacovigilance
- Globalisation of pharmacovigilance
- Transparency in pharmacovigilance data and systems
- Safety launches
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| | Dr John Balian, Senior VP Global Pharmacovigilance and Epidemiology, , Bristol Myers Squibb
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9.30am | Drug Safety Challenges for the Pharmaceutical Industry
- Post Marketing Solutions used in other industries
- Improving signal detection and validation
- Personalized medicine
- Improving communication with consumers
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10am | Safety sciences - how far have we come and where are we heading?
- The business drivers imposing change in pharmaceutical drug safety
- Key ingredients in Safety Sciences in the pre-market and post-market safety arenas, can it be done?
- Forecasting the future, or looking into the safety sciences crystal ball
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10.30am | Morning tea
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| CURRENT & PROPOSED REGULATORY INITIATIVES |
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11am | Key US drug safety regulatory developments
- Update on recent regulatory developments
- FDA Amendment Act: what affect has this had on the drug safety industry?
- Implementation and evaluation of RiskMAPs
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11.30am | Conditional authorisation and early post-marketing phase vigilance systems for new drugs in Japan
- Overview of drug safety in Japan
- Focus on the conditional authorisation and EPPV systems, introduced in Japan to control the safety of new drugs just after launch
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| | Dr Osamu Doi, Chief Executive, Society of Japanese Pharmacopoeia
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11.59am | Afternoon chair
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12pm | EU Commission: strategy to better protect public health by strengthening and rationalising EU pharmacovigilance
- Overview of the Commission’s legislative proposals to strengthen and rationalise the EU system of pharmacovigilance
- Impacts on the biotechnology industry and key messages from EuropaBio on the legislative proposal
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| | Michael Leader, Director of the Healthcare Council, EuropaBio - The European Association for Bioindustries
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12.30pm | Role of the Medical Monitor within the Pharmacovigilance team
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| | Robert Miller, Chief Medical Officer, Fulcrum Pharma (Europe) Ltd
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1pm | Lunch
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2pm | The promise and pitfalls of signal detection in the new electronic health record (EHR)
- EHR and technology in retrospective and prospective signal detection
- Structural and coding considerations
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2.30pm | Integrating quantitative signal detection into safety monitoring processes - experiences from industry and health authorities
Mr. Blackwell will describe current practices and lessons learned from several recent projects that integrate quantitative signal detection techniques into broader safety monitoring procedures to deliver consistent, systematic and efficient review processes that deliver timely documented results. |
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Day one - Stream I CLINICAL SAFETY
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3pm | Opening remarks from the chair
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3.05pm | Organ specific safety assessment: heart and liver differences and communalities
- Early cardiac safety signals and the Thorough QT study
- Hepatic safety monitoring - looking for a needle in a haystack
- Safety assessment in clinical development as a continuous process - some methods and pitfalls.
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3.35pm | Speed networking
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4.15pm | Afternoon tea
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4.35pm | The complexities in designing a thorough QT study
- Thorough QT Study both from a methodologic point of view and critically from a utility point of view
- Prediction of safety with respect to syncope
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5.05pm | Risk Management in Clinical Trials
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5.35pm | Closing remarks from the chair
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5.45pm | Networking drinks reception
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Day one - Stream II DATA MANAGEMENT AND ELECTRONIC SUBMISSIONS
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3pm | Opening remarks from the chair
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3.05pm | Electronic submission safety data reporting
- The globalisation of electronic submission – where are we?
- FDA update
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3.35pm | Speed Networking
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4.15pm | Afternoon tea
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4.35pm | Electronic submission safety data reporting – regulators perspective
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5.05pm | Maximising the benefit of MedDRA
- The role of MedDRA in clinical trial drug safety and post marketing drug safety
- Background and implementation of adverse event coding – how is the industry coping
- Maximising the impact of MedDRA through efficient data entry, retrieval and analysis
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5.35pm | Closing remarks from the chair
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5.45pm | Networking drinks reception
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Day two - Thursday 18 September 2008
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8am | Registration and coffee
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8.50am | Opening remarks from the chair
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| INTERNATIONAL DRUG SAFETY LANDSCAPE |
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9am | Drug safety: are we asking the right questions?
- Drug safety: has the risk increased? If so, why so?
- Patient, prescriber and product factors: are we targeting the whole safety trial?
- New regulatory safety schemes: will they confirm or confuse the right risk-benefit balance?
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9.30am | Case study: pharmacovigilance practical issues for biological products
- Major considerations of pharmacovigilance in biological product development program: assessment of immunogenicity, management of events that may associated with biological products such as infection and malignancies
- Post marketing pharmacovigilance challenges for biological product: assessment risk for long latency, rare, and severe adverse events.
- Assessment of biological product quality associated risk,
- Major consideration for post-approval safety studies for biological products
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10am | The role of the QP in pharmacovigilance
- The key roles and legal implications of the QPPV
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10.30am | Pharmacovigilance in the European Union: the latest on Volume 9a
- The implementation of Volume 9a and its effect on the industry
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11am | Morning tea
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11.30am | Pharmacovigilance in Europe
- Pharmacovigilance update: regulations and requirements for Europe
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12pm | Maximising the expertise of ethics boards in drug safety
- Is this just an observational role?
- What impact do ethics boards have?
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12.30pm | Epidemiological studies in drug safety
- Epidemiology data and methods in supporting safety assessment during drug clinical development phases
- Epidemiology study designs in active safety surveillance in post-approval
- Epidemiology research in drug risk investigation, risk measurement, and evaluation of risk minimization effectiveness
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1pm | Lunch
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Day two - Stream I AUDITS & INSPECTIONS
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2pm | Opening remarks from the chair
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2.05pm | Pharmacovigilance inspections – an industry experience
- Getting ready for the first inspection in November 2003
- What we did and how we coped
- The return: March 2007
- How things have changed
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2.35pm | GMP in pharmacovigilance – regulatory perspective
- GMP-pharmacovigilance interface: part of an integrated system for risk identification
- Actors and organisations
- Regulation requirements
- Impact of pharmacovigilance inspections and findings
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3.05pm | GMP in pharmacovigilance – industry perspective
- Role and applicability of quality systems
- Basis for formalized systems:
- Comparisons and interfaces across the GxPs
- Practical GMP examples which can be used in PVG and beyond
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3.35pm | Pharmacovigilance Inspections - CRO perspective
- Preparation: contract and process description
- Cooperation during the inspection
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| PHARMACOVIGILANCE IN CANADA, SOUTH AMERICA AND THE PACIFIC RIM / ASIA |
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4.05pm | Afternoon tea
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4.30pm | Pharmacovigilance Developments in Canada
- Recent development and specific requirements for pharmacovigilance in Canada
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| | Dr Marc Berthiaume, Director Marketed Pharmaceuticals and Medical Devices Bureau , Health Canada
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5.05pm | Pharmacovigilance in South America
- An industry perspective on pharmacovigilance operations in South America
- Specific requirements for working within the region
- Keeping up to date and adhering to regulatory guidelines
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5.35pm | Closing remarks and end of conference
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Day two - Stream II RISK MANAGEMENT
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2pm | Chairmans opening remarks
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| | Andrew Cooper, Health Sciences Senior Sales Consulting Manager, ORACLE GB
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2.05pm | Improving risk management strategies
- Detailed analysis of European risk management strategy and its role in improving drug safety
- Role of ENCePP in future risk management
- Moving from compliance to a proactive risk management strategy
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2.35pm | Risk management in industry
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3.05pm | Case Studies in Outsourcing Drug Safety Narrative Writing for PSURs and NDAs and Adverse Event and Litigation Case Processing to India |
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3.35pm | Pharmacovigilance - addressing the challenges through proactive risk management
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| | Andrew Cooper, Health Sciences Senior Sales Consulting Manager, ORACLE GB
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4.05pm | Afternoon tea
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| SIGNAL DETECTION |
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4.35pm | Balancing benefit and risk: future directions
- Benefit-risk: putting all the parts together
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| | Dr John Ferguson, VP Global Head of Pharmacovigilence and Medical Safety, Novartis Vaccines & Diagnostics
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5.05pm | Optimising signal detection in drug safety
- Detection and evaluation of signals
- Available tools and databases
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| | Dr William Maier, Director/CEO, MAPI-EPI (former Senior Director Epidemiology, Elan)
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5.35pm | PSURs and Harmonised Birthdates: an industry experience
- Our experiences so far with implementation of the HBDs
- Status of Harmonisation in Europe and outside Europe
- Experiences with the common assessments
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6.05pm | Closing remarks and end of conference
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