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The importance of developing effective pharmacovigilance systems has been fuelled by an increased focus on drug safety and the ever-changing regulatory environment. SMi’s inaugural Pharmacovigilance conference will explore key issues such as inspections, risk management, the use of Independent Data Monitoring Committees and establishing relationships with regulatory bodies. Attend and gain insights that will enhance your management skills and facilitate a more successful drug development strategy.

 

  • Hear the latest updates on pharmacovigilance systems in the industry
  • Explore ways in which you can optimise your own pharmacovigilance activities
  • Discuss the potential impact of impending regulatory changes
  • Learn more about the relationship between drug safety and pharmacovigilance
  • Network with industry associates and discuss experiences
 

 

 Heads, Managers, Directors and Vice Presidents of:

  • Pharmacovigilance
  • Regulatory Affairs
  • Drug Safety
  • Risk Management
  • Drug Surveillance
  • Pharmacoepidemiology
  • Drug Development
  • Post-marketing Safety
  • Operations
  • Compliance
  • Quality Assurance
  • Medical Affairs
  • Epidemiology
  • Clinical Trials
  • Research and Development
 

 

Conference programme

8:30 Registration and coffee

9:00 Chairman's opening remarks

William Maier

William Maier, Vice President, Epidemiology, Drug Safety and Risk Management, MAPI-EPI

9:10 OPTIMISING PHYSICIANS AND HEALTHCARE PROFESSIONALS IN GLOBAL PHARMACOVIGILANCE

John Drake

John Drake, Safety Operations Physician Manager, F. Hoffmann-La Roche

  • A vital colleague accountable for the medical cohesiveness of ICSRs
  • Providing clinical judgment to colleagues responsible for case processing activities
  • Understanding the product profile and actively supporting safety teams
  • Establishing a collaborative environment between safety operations, safety science and clinical science
  • Safety physicians role in leading the risk management activities
  • 9:50 POST MARKETING DRUG SAFETY AND RISK MANAGEMENT – THE NEW REALITY

    William Maier

    William Maier, Vice President, Epidemiology, Drug Safety and Risk Management, MAPI-EPI

  • 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
  • Risk Management Planning – US/EU Regulations, Tools and Strategy
  • 10:30 Morning coffee

    11:00 THE ICH INDIVIDUAL CASE SAFETY REPORT SIGNIFICANT CHANGES AHEAD: WHY AND HOW?

    Andrew Marr

    Andrew Marr, Director, Global e-Regulatory Development, Global Regulatory Operations, GlaxoSmithKline

  • Transition of the ICH standard from 'home-grown' to an international standard
  • Rationale for the change - collaboration with HL7/ISO/CEN
  • Changes anticipated and associated timelines
  • 11:40 SAFETY SPECIFICATION AND RISK MANAGEMENT: THE ROLE OF THE RESEARCHER

    Saad Shakir

    Saad Shakir, Director, The Drug Safety Research Unit

  • How to develop safety specification and identify issues and missing information
  • The role of drug utilisation studies to support risk management
  • Pharmacoepidemiological studies
  • Monitoring the effectiveness of risk management
  • Case studies
  • 12:20 Networking lunch

    13:50 INTERNAL AUDIT STRATEGY FOR PHARMACOVIGILANCE

    Benoit Nauge

    Benoit Nauge, Senior Manager, Compliance GRDC - Global Compliance Auditing, Amgen

  • How to define and maintain the audit universe
  • The risk-based approach in practice
  • Creating and validating the audit plan
  • Implementing the audit plan
  • 14:30 PLANNING FOR HL7

    Simon Sparkes

    Simon Sparkes, Vice President, Europe, ArisGlobal

  • Overview of requirements
  • Timelines
  • Impact on safety systems and electronic reporting
  • Implementation planning
  • 15:10 Afternoon Tea

    15:40 DRUG SAFETY: A VIEW FROM A PHARMACOVIGILANCE REGIONAL CENTRE

    Alfonso Carvajal

    Alfonso Carvajal, Professor of Pharmacology, Institute of Pharmacoepidemiology, University of Valladolid

  • Spontaneous reporting
  • Signal follow-up
  • Case/non-case approach
  • Causality reasoning in pharmacovigilance
  • 16:20 DEVELOPING A PROACTIVE APPROACH TOWARD INSPECTIONS

    Jacques Wodelet

    Jacques Wodelet, Global Head of Quality Intelligence and Consultation, Merck-Serono

  • Inspection Objectives
  • Visual Thinking and process mapping
  • Categories of individuals
  • Inspection readiness
  • Technical and financial aspects
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration and Coffee

    9:00 Chairman's opening remarks

    Ralph Edwards

    Ralph Edwards, Medical Advisor, Uppsala Monitoring Centre

    9:10 CIOMS VIII: SIGNALS AND BEYOND

    Ralph Edwards

    Ralph Edwards, Medical Advisor, Uppsala Monitoring Centre

  • Role of Council for Organisations of Medical Sciences
  • Impending publication of CIOMS VIII
  • Data-mining of longitudinal health care records
  • Risks and benefits
  • 9:50 QUALITY MANAGEMENT SYSTEMS IN PHARMACOVIGILANCE

    Lucy  Hampshire

    Lucy Hampshire, Quality Manager, Global Patient Safety Division, Eli Lilly

  • What system should be in place to support pharmacovigilance legislation and guidelines?
  • Essential features of a robust quality management system
  • Quality oversight at both a global and local marketing affiliate level
  • Internal audits of a pharmacovigilance system
  • 10:30 Morning coffee

    11:00 OPTIMISING THE BENEFIT/RISK PROFILE WITH EFFECTIVE RISK MANAGEMENT PLANNING THROUGHOUT DRUG DEVELOPMENT

    Sian Ratcliffe

    Sian Ratcliffe, Senior Director, Safety and Risk Management Lead, Pfizer

  • Risk Prediction in early development
  • Risk identification and mitigation in mid and late development
  • Safety review/analysis plans
  • Regulatory Expectations and Interactions, REMS and RMPs
  • 11:40 CASE STUDY

    Petra Heyen

    Petra Heyen, Vice President, Regulatory Affairs and Pharmacovigilance, Therabel Pharma

  • Legal background
  • Implementation of a pharmacovigilance system in a small European company
  • Increasing efficiency in a standardised global pharmacovigilance process
  • What worked well
  • Opportunities for improvement
  • 12:20 Networking lunch

    13:50 DRUG SAFETY IN THE CONTEXT OF CLINICAL TRIALS

    Ian Ford

    Ian Ford, Director, Robertson Centre for Biostatistics, University of Glasgow

  • Importance of IDMC make-up and charter
  • Roles of IDMCs in phases I/II/III
  • Optimising IDMC reports
  • Potential for low-cost large randomised drug safety trials in phase IV
  • 14:30 FINDING THE WOOD AMONGST THE TREES – HOW TO EVALUATE A POTENTIAL SAFETY SIGNAL

    15:10 INTERNATIONAL REGULATORY DIVERSITY FACING GLOBAL PHARMACOVIGILANCE

    Helen Usmar

    Helen Usmar, Independent Pharmaceutical Consultant and Company Director, PharmaTracks

  • International regulatory differences for global products
  • Global roles - the role of the EU Qualified Person for Pharacovigilance
  • Global risk management
  • A Global PSUR - a possibility?
  • 15:50 Chairman's Closing Remarks

    16:00 Afternoon Tea and Close of Conference

    +

    Workshops

    Pharmacovigilance Inspections: A Practical Approach
    Workshop

    Pharmacovigilance Inspections: A Practical Approach

    Crowne Plaza Hotel - St James
    17th March 2010
    London, United Kingdom

    Crowne Plaza Hotel - St James

    Buckingham Gate 45/51
    London SW1E 6AF
    United Kingdom

    Crowne Plaza Hotel - St James

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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