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It is only recently that pharmacovigilance has received the prominence that it deserves as a result of ADR reporting coming under close scrutiny over the past few years. It has been recognised that ADRs may be responsible for more than 100,000 US deaths nation-wide each year - making it one of the leading causes of death (Lazarou et al., 1998). Incredibly, it is now believed that ADRs are ranked fourth leading cause of death behind heart disease, cancer and strokes.

With this knowledge in mind, our challenge at SMi was to assemble key industry peers from across the pharmaceutical spectrum that would provide pertinent and up-to-date information on pharmacovigilance - an arena that remains in constant flux. As you can see from this brochure we have achieved our goal.

Why should you attend this event? This is your opportunity to meet senior industry and government figures and seek their advice and opinions. This comprehensive conference will embrace the most important issues within pharmacovigilance today including signal detection, causality analysis, PSURs, IT integration and licensing issues. Moreover, top industry specialists will discuss their personal experiences by revealing best practice case studies from their respective companies.

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Dr Munaf Ali

Dr Munaf Ali, Vice President Regulatory Affairs & Pharmacovigilance, Ingenix

9:10 THE PRINCIPLE GOALS OF PHARMACOVIGILANCE - WHY WE EXIST? AND WHERE WE ARE GOING?

Dr Kasia Petchel

Dr Kasia Petchel, Director, European Drug Safety & World-Wide Safety, Pfizer

  • Pharmacovigilance: a historical perspective; Who are major players in pharmacovigilance?
  • Europe; World; Why we need dynamic interfaces in pharmacovigilance?
  • Tools available to pharmacovigilance; Spontaneous reporting systems
  • Risk-benefit assessment of drug interactions; Pharmacoepidemiology databases
  • Facing the consequences of non-compliance; Understanding the impact on public health
  • Quo vadis pharmacovigilance?
  • 9:40 EUROPEAN REGULATORY REQUIREMENTS IN A CHANGING CLIMATE

    Stephen Day, Dr Lee Evans

    Stephen Day, Dr Lee Evans, Regulatory Affairs Consultant, Medical Writer, PRI Group

  • What is the European regulatory environment?
  • Understanding the regulatory framework in place with a focus on recent changes
  • Regulations; Guidelines; Directives
  • Effect of current changes on existing regulatory guidelines
  • Key advantages of implementing national regulations
  • 10:20 A SPONSOR'S VIEW ON DRUG SAFETY

    Prof Georg Benker

    Prof Georg Benker, Head, Drug Safety, Merck KGaA

  • Drug safety databases; A pharmacovigilance system is more than just a database
  • Managing clinical safety data; Using safety data for regulatory compliance
  • Causality assessment by the investigator and by the sponsor
  • Using safety data for generating to development core safety information
  • Detection of risks that could affect the drug project
  • Communication of safety problems within the company; Problems and possible solutions
  • 11:00 Morning Coffee

    11:20 ADR REPORTING IN CLINICAL TRIALS

    John Freeman

    John Freeman, Head, International Clinical Safety - Europe, Amgen

  • Regulatory considerations
  • Factors that contribute to the array of requirements
  • Management of general requirements and associated problems
  • Ensuring compliance with expedited and periodic reporting
  • Examination and interpretation of events
  • 12:00 THE ROLE OF CROs IN PHARMACOVIGILANCE

    Dr Joy Chuwujinduo

    Dr Joy Chuwujinduo, Head, Pharmacovigilance, Akos

  • The Need for: Premarketing, Postmarketing
  • Medical Information and pharmacovigilance for small and virtual companies
  • Coordinating pharmacovigilance activities between MAH and distributors
  • European centre for Japanese, Canadian and US Companies
  • Pros and cons
  • Outsourcing versus cosourcing
  • 12:40 Networking Lunch

    14:00 THE CHANGING FACE OF SAFETY MONITORING FOR MARKETED PHARMACEUTICALS

    Dr Brian Edwards

    Dr Brian Edwards, Senior Director & Head, World-Wide Pharmacovigilance, Parexel

  • Globalisation: what does it mean and are you ready?
  • Outsourcing pharmacovigilance
  • Market introduction: how might pharmacovigilance and marketing interact?
  • Implications of this interaction for safety studies
  • Acceleration of time to market and peak market penetration: implications for pharmacovigilance
  • Looking ahead
  • 14:40 PARTNERSHIP, A NEW MODEL FOR SAFETY DATA MANAGEMENT

    Janet Green

    Janet Green, Business Development Manager, Safety Surveillance & Reporting, Quintiles Ireland

  • Benefits for Sponsor and CRO
  • Case study of a clinical study
  • Case study of a marketed product
  • Efficiencies gained via partnership
  • Metrics and process improvements
  • 15:20 Afternoon Tea

    15:40 CLINICAL SAFETY DATA MANAGEMENT: OPPORTUNITIES AND PERSPECTIVES

    Dr Enrico Marchesi

    Dr Enrico Marchesi, European Safety Manager, Schering-Plough

  • PSURs: what are they?; Understanding the timing of the reports
  • Three key pieces of the document; Estimation of patient exposure
  • Overall safety evaluation
  • Conclusions: what’s new, what’s different and what’s important
  • Implementation issues; Regulatory; Company
  • Future challenges: harmonisation
  • 16:20 POSTMARKET ISSUES CONCERNING MEDICAL DEVICES

    Bernard Tremaine

    Bernard Tremaine, Principal Consultant, Medical Device & QA Consultancy

  • Postmarket feedback; Vigilance reporting
  • Product recall and advisory notice issue
  • Quality management system links; Corrective and preventive actions
  • Management review; Iso 9001:2000 implications
  • Continuous improvement
  • 17:00 TRENDS IN SAFETY DATA COLLECTION

    Speaker to be confirmed

    Speaker to be confirmed, , Ministry of Defence

  • Data requirements
  • Seriousness vs. severity
  • Transmission of data
  • Effect of safety data on drug development: regulatory requirement for quality, safety and efficacy
  • Future directions at Clinical Data Care
  • 17:10 Networking Drinks Reception

    17:30 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Joe Irwin

    Joe Irwin, Operations Officer, European Society of Regulatory Affairs (ESRA)

    9:10 IDENTIFICATION AND INVESTIGATION OF SIGNALS: EARLY WARNING MECHANISMS

    Prof Ralph Edwards

    Prof Ralph Edwards, Medical Advisor, Pharmcovigilance & Centre Director, WHO Uppsala Collaborating Centre for International Drug Monitoring

  • ‘Signal’ defined; Current procedures in signal generation
  • How is the threshold for inclusion determined?
  • Loopholes in the current system
  • Implementation of neural networks by the WHO
  • Signal generation using this approach; External databases used
  • New procedures: validating the new systems
  • 9:40 PHARMACOVIGILANCE: THE IMPACT OF THE INTERNET

    Pauline McKenzie

    Pauline McKenzie, Business Analyst, International Product Safety & Pharmacovigilance, GlaxoWellcome

  • Recent developments in regulatory software and information management technology
  • Can IT revolutionise the ADR process?
  • Entering, validating and retrieving data
  • Can patient confidentiality be maintained and corporate secrets preserved?
  • Risks vs. benefits of using the internet as a backbone
  • 10:20 USING ELECTRONIC DATABASES FOR PHARMACOVIGILANCE INFORMATION

    Lauret Ballsun

    Lauret Ballsun, Senior Director, Global Safety Surveillance & Product Information, Elan

  • Choosing the appropriate database that balances searching ability with capacity
  • Analysing collated ADRs to establish signals for particular drugs and enhance your detection of drug safety issues
  • Using your database to generate electronic reports in the appropriate format for submission to the regulatory authorities
  • 11:00 Morning Coffee

    11:20 LICENSING ISSUES IN PHARMACOVIGILANCE

    Kathleen Sullivan

    Kathleen Sullivan, Global Head, Pharmacovigilance Licensing, Roche

  • Starting with the basics (definitions, regulations, liability)
  • Keeping in the corporate licensing loop
  • Mapping the process; Key documentation (SOPs, checklists, the written agreement)
  • Challenges in 3rd party negotiations (databases, literature, coding practices)
  • Keeping people informed
  • Compliance (performance metrics, tracking systems, feedback)
  • 12:00 DRUGS AND ADVERSE EVENTS: ASSOCIATION OR CAUSATION?

    Vasco Maria

    Vasco Maria, vice Chairman, Management Board, Infarmed

  • Why causality assessment is important; When to assess causality
  • What is the role of imputation systems
  • Global introspection
  • Algorythms and decision trees
  • Bayesian models; Causality attribution and common sense
  • Case study: drug-induced hepatitis
  • 12:40 Networking Lunch

    14:00 REPORTING OF ADVERSE DRUG REACTIONS FROM CLINICAL TRIALS

    Graeme Ladds

    Graeme Ladds, Head, Global Pharmacovigilance, Shire

  • Regulatory requirements: deciding which reports to submit
  • Requirements for new products in clinical trials
  • Practical problems that may be encountered
  • Work together with investigators to report serious adverse events
  • Interpretation of events
  • 14:40 PHARMACOEPIDEMIOLOGY STUDIES

    Dr Bart Teeuw

    Dr Bart Teeuw, Director Drug Safety & Quality Assurance, Vigilex

  • What is the purpose of these studies and when should you conduct one?
  • Identifying data sources of interest
  • Getting grips with a plethora of study methodologies
  • The potential to anticipate ADRs?
  • Limitations of these studies
  • 15:20 Afternoon Tea

    15:40 LABELLING ISSUES IN PHARMACOVIGILANCE

    Dr Michele Sangeleer

    Dr Michele Sangeleer, Pharmacovigilance Manager, Eli Lilly

  • Core data sheets for new drugs: impact on harmonisation
  • Format and content of a core data sheet
  • Systems and processes to achieve global alignment
  • Striving for harmonisation: ensuring meticulous documentation
  • Worst case scenarios: what can happen if labelling and harmonisation are not met
  • 16:20 PHARMACOVIGILANCE, A VISION FOR THE FUTURE

    Dr Steen Ottosen

    Dr Steen Ottosen, Manager, Information Management, Lundbeck

  • Science and epidemiology in pharmacovigilance
  • Electronic communication and standardisation
  • Expedited reporting and other means of data collection
  • Global utilisation of pharmacovigilance data
  • Cooperation of Industry, public research and authorities
  • 17:00 Chairman's Closing Remarks and Close of Conference

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    Workshops

    Medical Device Vigilance and Post Market Surveillance
    Workshop

    Medical Device Vigilance and Post Market Surveillance

    The Hatton, at etc. venues
    23rd February 2001
    London, United Kingdom

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

    HOTEL BOOKING FORM

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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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