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The SMi Group proudly presents our 3rd Annual Reporting Adverse Events Conference and Executive Briefing, to be held in London this coming April.

The reporting of adverse events in pre clinical, clinical and post clinical studies has never been so scrutinized by both regulatory institutions and the public eye, and this conference will equip you and your company with the necessary information to stay ahead of the field in this ever-changing industry.

Our unrivalled, eclectic speaker panel will present specific studies regarding rare genetic diseases, phase IV trials, early stage signal detection, morbidity and mortality studies, combination products and vaccine trials.

Industry experts will give technical advice on Eudravigilance, the role of the QP, pharmacovigilance audits, EMEA/FDA inspections and ICSR electronic submissions.

Recent results from the World Health Organisation’s (WHO) study into artificial intelligence and data in pharmacovigilance will be presented and discussed, as will strategies that restore public faith in clinical trials.

The conference will be delivered by an excellent panel of speakers, including:

  • Dr Wytske Kingma, Senior Vice President, Global Pharmacovigilance and Medical Information, Genzyme Corporation
  • Dr Uwe Maennl, Vice President and Head, Pharmacovigilance Services, PAREXEL
  • Dr John Ferguson, Vice President, Pharmacovigilance, Millennium Pharmaceuticals
  • Dr Mason Diamond, Vice President, Clinical and Regulatory Affairs, TyRx Pharma
  • Dr John Whitebrook, Vice President, Practice Management, IntraSphere
  • Dr Mariska Kooijmans- Coutinho, Senior Director, Drug Safety and Risk Management, Biogen Idec
  • Dr Drew Kilpatrick, Director, Pharmacovigilance and Medical Affairs, Kendle International
  • Professor Ralph Edwards, Centre Director & Medical Advisor Pharmacovigilance, World Health Organisation (WHO) Collaborating Centre for International Drug Monitoring

Essential updates provided on

  • THE RESULTS OF THE WORLD HEALTH ORGANISATION’S (WHO) study into artificial intelligence and data in pharmacovigilance
  • EFFECTIVE GLOBAL SAFETY STRATEGIES from global pharmaceutical leaders
  • OVERCOMING the unique challenges faced in trials of combination products in reporting adverse events
  • RISK MANAGEMENT strategies that restore public faith in clinical trials
  • SUCCESSFUL early stage signal detection and phase IV trials
  • NEW AND EVOLVING regulatory requirements for safety data reporting, audits, inspections and the QP
    • This conference is CPD acredited- 10 credits

    Conference programme

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Dr Eva  Miller

    Dr Eva Miller, Associate Director, Almac Clinical Technologies

    9:10 SAFETY SURVEILLANCE AND RISK MANAGEMENT IN RARE GENETIC DISEASES

  • Safety profile in small populations
  • Understanding safety when the disease itself is not yet understood
  • Proactive management of infusion sites in order to avoid complications
  • Disease-related risk factors need to be included in risk management plans
  • Successful communications to global community result in safe products
  • Dr Wytske Kingma

    Dr Wytske Kingma, Senior Vice President, Genzyme Corporation

    9:50 GOOD SCIENCE IN PHASE IV

  • Statistical considerations impacting post-marketing studies
  • Identification of analysis techniques specific to observational trials
  • Identification of methods and tools to enhance efficient study implementation
  • Dr Eva  Miller

    Dr Eva Miller, Associate Director, Almac Clinical Technologies

    10:30 Morning Coffee

    11:00 HANDLING EMEA/FDA INSPECTIONS

  • Challenges faced and insights into inspections
  • Inspection grading/results
  • UK perspective on inspections
  • Different types of inspections eg. pharmacovigilance, for- cause, sponsor, investigator site
  • Andrew  Cooper

    Andrew Cooper, Section Director, Pharmacovigilance, Astra Zeneca Pharmaceuticals

    11:40 WEB-BASED APPROACH TO INDEPENDENT ADJUDICATION OF ENDPOINTS

    Dr Drew Kilpatrick

    Dr Drew Kilpatrick, Director, Pharmacovigilance and Medical Affairs, Kendle International

  • Endpoints in morbidity/mortality studies are invariably SAEs/SUSARs
  • Remote electronic adjudication of endpoints offers an alternative to a paper-based approach
  • Adjudicators have access to all documents/scans/images from their office or home
  • An electronic adjudication form is completed with immediate access to outcome
  • Web-based access to documents facilitates translation to a language of choice
  • More efficient confirmation of endpoints reduces risk of over recruitment and over exposure in potentially high risk morbidity/mortality studies
  • 12:20 Networking Lunch

    13:50 DEVELOPING A GLOBAL PHARMACOVIGILANCE PLAN

    Dr John  Ferguson +

    Dr John Ferguson +, Vice President, Pharmacovigilance, Millennium Pharmaceuticals

  • Integration across the EU and the USA
  • Effective pharmacovigilance in multi-site trials
  • Responses of country-specific CRO’s
  • The role of national authorities
  • 14:30 THE ROLE OF THE EU QUALIFIED PERSON IN PHARMACOVIGILANCE

    Salvador García de Quevedo Pérez

    Salvador García de Quevedo Pérez, Director, Global Product Safety, European Operations, Eli Lilly

  • Legal responsibilities
  • Preparing the adverse reaction report and expedite reporting
  • Preparing the periodic safety update report
  • Working with risk management plans
  • Challenges faced
  • 15:10 Afternoon Tea

    15:40 CONDUCTING PHARMACOVIGILANCE AUDITS

    Mercedes Martinez

    Mercedes Martinez, Senior Auditor, Medical Quality Assurance- Auditing and Compliance, Patient and Product Safety, Eli Lilly

  • Specific pharmacovigilance audits
  • Conforming to regulatory and legal obligations
  • Frequent findings
  • Maximising the efficiency of the audit procedure
  • 16:20 THE EUDRAVIGILANCE NETWORK, SAFETY DATA REPORTING

    Dr Dieter Konrad

    Dr Dieter Konrad, Senior Consultant Medical Information Systems, Boehringer Ingelheim Pharma K G

  • Structure and function of Eudravigilance
  • Fundamental information on the reporting of ICSR’s
  • Understanding and using the Eudravigilance medicinal product dictionary
  • Coping with a system failure
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    Dr Eva  Miller

    Dr Eva Miller, Associate Director, Almac Clinical Technologies

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Dr Mariska Kooijmans- Coutinho

    Dr Mariska Kooijmans- Coutinho, Senior Director, Drug Safety and Risk Management, Biogen Idec

    Dr Barry Arnold

    Dr Barry Arnold, EU Qualified Person for Pharmacovigilance, AstraZeneca

    9:10 ARTIFICIAL INTELLIGENCE AND DATA IN PHARMACOVIGILANCE

    Professor Ralph Edwards

    Professor Ralph Edwards, Centre Director & Medical Advisor Pharmacovigilance, WHO Collaborating Centre for International Drug Monitoring

    9:50 RESTORING PUBLIC TRUST AND REBUILDING REPUTATIONS

    Dr Uwe Maennl

    Dr Uwe Maennl, Vice President and Head, Pharmacovigilance Services, Parexel

  • ‘It’s always the people who make the difference’
  • Management of change in the ever-developing PV environment
  • Regulatory challenges in drug safety and their impact on organisational structures
  • Globalisation and workforce mobility: Goodbye to old structures?
  • Role of professional managers in PV systems
  • 10:30 Morning Coffee

    11:00 EFFECTIVE RISK MANAGEMENT

  • Its importance and value
  • Regulatory expectations
  • Measuring effectiveness
  • The ideal risk management plan
  • Dr Barry Arnold

    Dr Barry Arnold, EU Qualified Person for Pharmacovigilance, AstraZeneca

    11:40 SAFETY DATA REPORTING: ENSURING COMPLIANCE WITH EU/US REGULATIONS

    Dr John  Whitebrook

    Dr John Whitebrook, Vice President, Practice Management, Instrasphere

  • Mandatory electronic ICSR reporting; a reality
  • Local requirements, highly varied and in flux
  • The resultant complex scenario
  • Difficulty of navigating and putting into practice rule setting
  • Discussion of real life scenarios and strategic and tactical approaches
  • 12:20 Networking Lunch

    13:50 EFFECTIVE EARLY STAGE SIGNAL DETECTION

  • Rapid identification of potential side effects
  • Various methods for signal detection
  • Dr Mariska Kooijmans- Coutinho

    Dr Mariska Kooijmans- Coutinho, Senior Director, Drug Safety and Risk Management, Biogen Idec

    Dr Glyn Belcher

    Dr Glyn Belcher, Senior Director, , Biogen Idec Ltd

    14:30 ADVERSE EVENTS REPORTING FOR COMBINATION PRODUCTS

    Dr Mason Diamond

    Dr Mason Diamond, Vice President, Clinical and Regulatory Affairs, TyRx Pharma

  • Unique challenges faced by combination products
  • Review of current requirements
  • FDA, ERA and GHTF Reactions and Potential Impact
  • Ongoing regulatory initiatives
  • 15:10 Afternoon Tea

    15:40 PHARMACOVIGILANCE WITHIN VACCINE TRIALS

    Dr Juergen Zorn

    Dr Juergen Zorn, Senior Medical Manager, Pharmacovigilance, Novartis Vaccines and Diagnostics, GmbH & Co. KG

    16:20 Chairman’s Closing Remarks and Close of Conference

    *subject to final confirmation

    Dr Mariska Kooijmans- Coutinho

    Dr Mariska Kooijmans- Coutinho, Senior Director, Drug Safety and Risk Management, Biogen Idec

    Dr Barry Arnold

    Dr Barry Arnold, EU Qualified Person for Pharmacovigilance, AstraZeneca

    +

    Workshops

    Identifying and Managing Responsibilities and Risks in Pharmacovigilance Outsourcing
    Workshop

    Identifying and Managing Responsibilities and Risks in Pharmacovigilance Outsourcing

    The Hatton, at etc. venues
    25th April 2007
    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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