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Pharmacovigilance is more than making reports to the authorities. Now in the 21st Century we have begun to analyse this area as we are just beginning to thoroughly understand what an adverse event entails. Regulatory authorities world-wide are requiring more formalised strategies to minimise safety risks throughout the drug product life-cycle.

This innovative conference will seek to inform attendees of the latest developments within Adverse Events Reporting: how to conduct effective analysis and interpretation, the principles of drug safety and identifying the critical data elements necessary. The new FDA Safety Tome Directive and the European Clinical Trial Directive will be discussed in relation to national variations and practical aspects. It will also examine how to encourage healthcare professionals to report adverse drug reactions, the practical implications of data privacy and the future of ADR reporting including Electronic Patient Reported Outcomes (ePRO).

A unique opportunity to learn from leading industry experts including:

Dr Martin Huber, Vice President, Drug Safety Risk Management, F. Hoffmann-La Roche
Dr Kasia Petchel, Vice President, Safety & Surveillance Reporting, Pfizer
Dr Barry Arnold, Vice President, Clinical Drug Safety, AstraZeneca
Dr Tjeerd-Pieter van Staa, Head, Pharmacovigilance & Epidemiology, Europe, Procter & Gamble Pharmaceuticals
Dr Renald Hennig, Executive Director, Pharmacovigilance, Chiron Vaccines
Prof Juhana Idänpään-Heikkilä, Secretary-General, Council for International Organisations of Medical Sciences (CIOMS), World Health Organisation (WHO)
Dr Joanna Haas, Senior Medical Director, Genzyme
Charlotte Barrett, Pharmacovigilance Manager, Merck Generics
Dr Erik Rasmussen, Safety Analyst, Novo Nordisk
Ronald Meyboom, Medical Adviser, The WHO Uppsala Monitoring Centre

The essential event on:

PHARMACOVIGILANCE: Where are we?
CLINICAL SAFETY SURVEILLANCE & RISK MANAGEMENT: Hear about signal detection, evaluation of risk and risk communication in the 21st century
REGULATORY REQUIREMENTS: Learn about pre- and post-marketing reporting, safety monitoring and the role of ethic committees
PHARMACOVIGILANCE IN THE USA: Get an insight into US pre-marketing reporting requirements for drugs and biologicals
DATA SUBMISSION: How does the flow of data work?
KEY INDUSTRY PERSONNEL: Meet the leaders in the field, learn from their experiences and make valuable contacts

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Ronald Meyboom

Ronald Meyboom, Medical Advisor, The WHO Uppsala Monitoring Centre

9:10 KEYNOTE ADDRESS

Ronald Meyboom

Ronald Meyboom, Medical Advisor, The WHO Uppsala Monitoring Centre

  • Background and principles
  • Methods, strengths and limitations
  • Causality assessment, signal detection
  • Science, regulation and education
  • International pharmacovigilance
  • 9:50 REGULATORY REPORTING OF SUSARs TO REGULATORY AUTHORITIES WORLDWIDE

  • Process for assessment and tracking
  • Cross reporting
  • Interactions with regulatory authorities
  • Experience with electronic reporting
  • Variations between different countries
  • Unblinding
  • Dominique Coleman

    Dominique Coleman, Product Specialist, Pharmacovigilance, Quintiles

    Alison Sloane

    Alison Sloane, Associate Group Manager, Pharmmcovigilance, Quintiles Ireland Limited

    10:30 Morning Coffee

    11:00 POST-MARKETING SURVEILLANCE STUDIES

    Gurdyal Kalsi

    Gurdyal Kalsi, Director, Medical Affairs, MDS Pharma Services

  • The enigma of ‘seeding studies’
  • Study design and SAMM (Sponsored Assessment of Marketed Medicines) guidelines compliance
  • Case studies
  • New horizons
  • Conclusions
  • References
  • 11:40 COMPLIANCE TO THE PROCESSES AND PRINCIPLES OF POST-MARKETING SAFETY MONITORING

    Charlotte Barrett

    Charlotte Barrett, Pharmacovigilance Manager, Merck Generics

  • Burdensome processes that lose sight of the principles of safety surveillance
  • Consideration of added value of strict compliance
  • What is the real risk to patient safety?
  • Resource implications for ‘cheaper’ medicines
  • Who should really be responsible for safety surveillance of established medicines?
  • 12:20 Networking Lunch

    13:50 Chairman for Afternoon Sessions

    Professor Juhana Idänpään-Heikkilä

    Professor Juhana Idänpään-Heikkilä, Secretary-General, Council for International Organisations of Medical Sciences (CIOMS), World Health Organisation (WHO)

    14:30 WHAT IS THE ROLE OF ETHICS COMMITTEES IN THE EU PHARMACOVIGILANCE SYSTEM?

    Brian Edwards

    Brian Edwards, Senior Director, Pharmacovigilance Specialist, PAREXEL International

  • Impact of the EU clinical trials directive and other legislation
  • Is the existing training and infrastructure relevant and adequate?
  • The current situation: how do they enhance protection of patients?
  • How should industry respond to their role and mutually help protect patients’ interests?
  • 15:10 Afternoon Tea

    15:20 US PRE-MARKETING REPORTING REQUIREMENTS FOR DRUGS AND BIOLOGICALS

     
  • What needs to be reported and when?
  • How do US requirements differ from other ICH regions?
  • What is ‘expected’ via the Investigator Brochure?
  • Reporting for products already marketed outside of the US
  • Reporting to an IND when an NDA exists for another indication
  • Handling blinded data
  • Role of DMCs in individual case reporting
  • Communicating with investigators about reportable cases
  • Nina Wolfendale

    Nina Wolfendale, Head, Compliance, Genzyme

    MaryAlice Worden

    MaryAlice Worden, Associate Director Lysosomal Storage Disorders, Genzyme

    16:20 CAUSALITY, RISK & RISK MANAGEMENT

    Renald Hennig

    Renald Hennig, Executive Director, Pharmacovigilance, Chiron Vaccines

  • Pros and cons of causality assessment
  • Validity of causality assessment
  • From signals to risks - thresholds and more
  • Risk management – theory and practice (case study)
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Ragnar Lofstedt

    Ragnar Lofstedt, Director, King's College London

    9:10 SIGNAL DETECTION

    Tjeerd-Pieter van Staa

    Tjeerd-Pieter van Staa, Head, Pharmacovigilance, Epidemiology Europe, Procter & Gamble Pharmaceuticals

  • What are the advantages and limitations of signal detection and data mining?
  • Should we apply these statistical techniques routinely to all our post-marketing and clinical safety data?
  • Should drug labelling be guided by data mining?
  • 9:50 EVALUATING RISK

    Kasia Petchel

    Kasia Petchel, Vice President, Safety & Risk Management, Worldwide Development, Pfizer

  • Communication and action
  • Follow-up
  • Impact
  • Revision of plans and action
  • 10:30 Morning Coffee

    11:00 MONITORING AND REPORTING ADVERSE REACTIONS

    Barry Arnold

    Barry Arnold, Vice President, Clinical Drug Safety, AstraZeneca

  • General pharmacovigilance requirements
  • Expedited and periodic ADR reporting requirements
  • Post-authorisation safety studies
  • Role of risk management plans
  • 11:40 BEST PRACTICE TOOLS AND TECHNIQUES FOR PHARMACOVIGILANCE QUALITY ASSURANCE

    Brian Dinardo

    Brian Dinardo, Principal, World Class International

    12:20 Networking Lunch

    14:00 PANEL DISCUSSION

    Barry Arnold

    Barry Arnold, Vice President, Clinical Drug Safety, AstraZeneca

    Brian Edwards

    Brian Edwards, Senior Director, Pharmacovigilance Specialist, PAREXEL International

    Ragnar Lofstedt

    Ragnar Lofstedt, Director, King's College London

    14:40 RISK COMMUNICATION IN THE 21ST CENTURY

    Ragnar Lofstedt

    Ragnar Lofstedt, Director, King's College London

  • Living in a post trust society
  • What should be the role of transparency?
  • What should be the role of deliberation?
  • Should one factor in the precautionary principle?
  • How do we rebuild public trust?
  • 15:20 Chairman’s Closing Remarks followed by Afternoon Tea

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    Mayfair Conference Centre

    17 Connaught Mews
    London W2 2EL
    United Kingdom

    Mayfair Conference Centre

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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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