Conference on 5th Annual Pharmacovigilance(Conference only)

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5th Annual Pharmacovigilance Conference
Implementing best practices in drug safety and surveillance

17th - 19th March 2010, BSG House, London, UK

Background Info
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
• Dr James Weatherall, Global Lead, Biomedical Informatics, AstraZeneca
• Dr K N Woodward, Head - Global Pharmacovigilance, Intervet - Schering-Plough Animal Health

Pharmacovigilance is becoming ever more critical for pharmaceutical companies as the public and legislative pressure to ensure drug safety increases every day. Effective implementation of pharmacovigilance can aid drug development, benefit rational communication and sound public understanding, taking emerging regulatory policies 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 emphasis on pharmacovigilance in the near future.

Visiongain's 5th Annual Pharmacovigilance conference will underpin processes and developments on many different elements including the regulatory and legislative framework, risk management, PSUR, live licensing, in drug safety and surveillance. With succinct themes, interactive sessions by key opinion leaders, our conference will bring latest insights, integrated strategies and best practices in pharmacovigilance.

Why Attend?

Gain knowledge on:
• Evaluation of risk mitigation activities: REMS and beyond from the pharmacoepidemiologist's perspective
• Regulatory focus on evaluation of risk mitigation strategies, contrasting the FDAAA, REMS and the EU-RMP
• Adverse drug reactions can be classification by mechanism (the EIDOS system) and by clinical presentation (the DoTS system)
• Pharmacovigilance in clinical trials of investigational medicinal products
• New Horizons: Proposals from the EU Commission "Pharma Package"
• Developing and implementing training programs for global pharmacovigilance systems, bridging geographies and requirements
• Pharmacovigilance in early phase oncology trials (Phase I & II)
• Implementing inspection readiness program as a guide to maximise readiness
• Drug safety investigation – Pre and Post Marketing

Who will attend?

VP’s, Directors, Heads, Managers, Scientific Advisors, Consultants of:
• Pharmacovigilance
• Pharmacoepidemiology
• Pharmacogenomics
• Drug/Product Safety
• Drug Development
• Information and Clinical Data Management
• Clinical Pharmacology
• Clinical Safety
• PSUR
• Risk Management
• Research & Development
• Quality Assurance
• QPPV
• Patient Safety/ Surveillance
• Signal Detection
• Outcomes Research
• Data Analysis
• Epidemiology
• Toxicology
• Medical Affairs
• Regulatory Affairs and Compliance
• Sales & Marketing

Workshop
Pre-Conference Interactive 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 and Deputy EU QPPV, EUSA Pharma
Lesley Deane, PhV Consultancy

Timings: 09:30 - 10:00 Coffee & Registration
10:00 - 17:00 Workshop
Timing includes lunch and refreshment breaks

Key Topics:

During this one day workshop we will explore the Safety Data Exchange Agreements (SDEA) for licensed and unlicensed products and how these are scrutinised by competent authority inspectors. This workshop will be an interactive and collaborative forum and help you achieve a thorough understanding on the following themes:
• Safety Data Exchange Agreements (SDEA) for licensed and unlicensed products i.e. those provided on a named patent basis
- Strategies for clear SDEA to ensure that all parties know what their responsibilities are
• Impact of acquisition and divestment of products or companies on the pharmacovigilance system
- Careful management of acquisition of a company or product to ensure transition and merger into the current pharmacovigilance system
- Implementation of divestment of products from the portfolio needs to ensure that all safety data is transferred from one MAH to another

About your workshop leaders:

Emma Boulton
Emma Boulton is currently the Global Head of Pharmacovigilance and Medical Information and Deputy EU QPPV at EUSA Pharma. Emma has 14 years experience in various drug safety roles in both the pharma industry and CRO.

EUSA Pharma
EUSA Pharma is a specialty pharmaceutical company with a strong and growing portfolio of specialised hospital medicines focused on oncology, pain control and critical care, which it markets predominantly in Europe and the US (as the company’s name suggests) through a network of EUSA affiliates and distributors.

Lesley Deane
Lesley Deane set-up a pharmacovigilance consultancy company specialising in pharmacovigilance audits and preparing companies for competent authority inspections in 1997. Lesley has over 20 years experience in the pharmaceutical industry, specific to pharmacovigilance and regulatory affairs, and membership to PIPA, BARQA and the British Institute of Regulatory Affairs.

Day 1
Day One, Thursday 18 March 2010

09:30 Registration and refreshments

10:00 Opening address from the chair

10:10 Evaluation of risk mitigation activities: REMS and beyond from the pharmacoepidemiologist's perspective
• Pharmacoepidemiologist’s role in risk management & pharmacovigilance
• Summarise the increased regulatory focus on evaluation of risk mitigation strategies, contrasting the EU & US legislation on risk mitigation evaluation (i.e. FDAAA, REMS and the EU-RMP)
• Case examples and current challenges to implementation

Dr Rachel Sobel
Senior Director, Epidemiology - Specialty Care BU Group Head
Pfizer

10:50 Approaching risk management through classification of adverse drug reactions
• Identification of those at risk of adverse drug reactions involves: knowledge of susceptibilities; availability of monitoring techniques; availability of protective techniques; the benefit: harm balance
• Adverse drug reactions can be classified by mechanism (the EIDOS system) and by clinical presentation (the DoTS system)
• Logical method for decision making in risk management

Prof Jeffrey Aronson
Reader in Clinical Pharmacology, University of Oxford
Immediate Past-President, British Pharmacological Society

11:30 Morning refreshments

11:50 Guidelines on risk management systems for medicinal products for human use
• EU guidelines on risk management plans - completion, data aspects, different product types
• RiskMAPs - FDAAA guidance, new regulations, impact for the US
• RoW - What are the requirements and where is this heading in the rest of the world?

Seema Jaitly
VP Global Medical & Scientific Affairs
Stiefel Laboratories, GSK

12.30 Regulatory affairs: Pharmacovigilance in Europe
• Overview of Notice to Applicants, Volume 9A
• The EUDRA Vigilance System
• New Horizons: Proposals from the EU Commission “Pharma Package”

Paolo Biffignandi
Chief Medical Officer, EU Vigilance
President, TOPRA

13:10 Networking lunch

14.30 Meta-analysis for safety
• Principles and regulatory guidance
• Addressing pre-approval signals
• Addressing post-approval signals
• Case examples and challenges

Dr Nawab Qizilbash
Director, OXON Epidemiology
Honorary Senior Lecturer, Imperial College, London University

15:10 Developing and implementing training programs for global pharmacovigilance systems, bridging geographies and requirements
• Challenges in developing and implementing a global PV training program: a case example
• How does one meet diverse customer training needs in a dynamic and highly regulated environment?
• Blended learning approaches: how to make the most of self-study, interactive e-learning and instructor led training?
• Solutions for global implementation: what tools can be used for remote training?

Dr Irene Michas
Director, Pharmacovigilance Education and Process Documentation (PEPD)
Pfizer

15:50 Afternoon refreshments

16:10 Quantitative safety signal detection: CIOMS Working Group VIII
• Overview of different quantitative methods being applied to safety databases to detect potential safety signals
• Introduction to the concept of an ‘Observation of Disproportional Reporting’
• Integration of quantitative methods and traditional qualitative methods into a signal detection program, including management of information generated by a signal detection program

Paul Dolin
Head
European Drug Safety

16:50 Application of text analytics to the surveillance of published literature
• Outline the fundamental challenges of conducting routine post-marketing surveillance on the published literature
• Explain why the utilisation of informatics approaches such as text analytics potentially addresses some of these challenges
• Discuss the success of an agile internal project in delivering a solution to employ such an approach within 6 months
• Overview on the business impact of the new system so far
• Looking ahead: Future enhancements, and alternative applications of the approach

Dr James Weatherall
Global Lead, Biomedical Informatics
AstraZeneca

17:30 Closing remarks from the chair

17:35 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting

Day 2
Day Two, Friday 19 March 2009

09:30 Registration and refreshments

10:00 Opening address from the chair

10:10 New strategy: Proactive approach towards inspections
• Inspection Objectives
• Graphic Thinking
• Visual Thinking & process mapping
• Inspection Readiness Program as a Guide to Maximize Readiness
• Technical & financial aspects to set-up a visual thinking – process mapping approach
• Quick Demo of the tool

Dr Jacques Wodelet
Head of Quality Intelligence & Consultation
Merck-Serono, Geneva

10:50 The contributions of the researcher to safety specification and risk management
• Thoughts about how to plan safety specification
• How can drug utilisation studies support risk management
• Reporting cycle for PSURs of registered products
• Studies to address potential risk, identified risk and missing information
• How to monitor risk management

Professor Saad Shakir
Director
Drug Safety Research Unit

11:30 Morning refreshments

11:50 Drug safety investigation – Pre and Post Marketing
• Regulatory – requirements and strategic consideration
• Signal generation – case investigation, trials, spontaneous events, databases, data mining
• Signal investigation – study designs and resources
• Comparison of methods used at different stages of drug development

Dr William C Maier
Vice President, Epidemiology/Drug Safety/Risk Management
Registrat-Mapi

12:30 Pharmacovigilance - Maximising the potential: Data is king
• Geographic and Population cover of data
• Quality of data
• Outputs- relative or absolute?
• The right data for the right purpose

Dr John Parkinson
Director
General Practice Research Database (GPRD), MHRA

13:10 Networking lunch

14.30 Pharmacovigilance in clinical trials of investigational medicinal products
• Strategy and practicalities for collection of safety data
• Risk management in clinical trials
• Use of Data Monitoring Committees (DMC)
• Analysis and presentation of safety data

Dr John Talbot
Director - Patient Safety, Processes & Standards
AstraZeneca R&D

15:10 Development Safety Update Report (DSUR): Harmonising periodic safety reporting during clinical trials
• CIOMS VII initiative and ICH E2F - where are we now?
• DSUR content - what is new compared to Annual Safety Reports (ASRs)?
• Use of DSUR to identify and to assess risks in clinical trial subjects - cross-talk with other safety regulatory documentsDevelopment Safety Update Report (DSUR): Harmonising periodic safety reporting during clinical trials

Pilar Carrero
Team Leader Safety Medical Writing
Novo Nordisk

15:50 Afternoon refreshments

16:10 Pharmacovigilance in early phase oncology trials – A case study
• Phase I and Phase II trials
• Trial document development (PIS/protocols/IBs)
• Ongoing safety review and involvement in critical decisions (e.g. dose escalation)
• Writing of Annual Safety Reports (ASRs)

Ben Jefferies
Pharmacovigilance Scientist
Cancer Research UK

16.50 Veterinary pharmacovigilance and human health
• Discuss how veterinary pharmacovigilance extends to animal health, environmental adverse effects, safety of veterinary residues in human food and human safety
• "Human adverse reaction" following exposure to a veterinary medicine
• Global legislation to deal with veterinary pharmacovigilance

Dr K N Woodward
Head - Global Pharmacovigilance
Intervet, Schering-Plough Animal Health

17:30 Chair’s closing remarks

17:40 End of Conference

Related Reports:

Understanding Pharmacogenomics
Pharmacovigilance Report and Analysis Present Challenges and Future Goals
Pharmacogenomics for Clinical Use and in Drug Development
Pharmacodiagnostics and Personalized Medicine 2009 (Markets, Challenges, Forecasts and Key Players)
Impact of Pharmacogenomics on Public Healthcare Policy: Educating patients, payors and healthcare providers