Home
overview

SMi’s Reporting Adverse Events will focus on a plethora of issues currently making waves in the industry. While exploring EU legislation and changes in FDA thinking, you will have the opportunity to learn how best to guarantee accurate adverse event reporting while ensuring the safety of their products. Looking at risk management practices and strategies used by the experts, you will be given an insight into the new and exciting area of adverse event reporting, discover how to secure the safety of products and shield them from risk.

Gain the necessary knowledge to ensure accurate adverse event reporting with the aid of effective drug safety management tools today!

This years speakers include:

  • Dr Tjeerd-Pieter van Staa, Head, Research, General Practice Research Database, Medicines Healthcare products Regulatory Agency (MHRA)
  • Dr John Ferguson, Vice President, Pharmacovigilance, Millennium
  • Dr Joanna Haas, Vice President, Pharmacovigilance, Genzyme
  • Dr Sean Zhao, Director, Global Safety, Pharmacovigilance, Amgen
  • Dr Lívia Stankovics, Affiliate Pharmacovigilance Head, Sanofi-Aventis
  • Dr Birgitt Gellert, Drug Safety Manager, Bayer Vital
  • Guy Pawson, Manager, Electronic Submissions, Genentech

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Sean Zhao

Sean Zhao, Director, Global Safety, Pharmacovigilance, Amgen

9:10 IMPACT OF THE CLINICAL TRIAL DIRECTIVE

Dr Dipti Amin

Dr Dipti Amin, Senior Vice President, Clinical & Scientific Operations, Medical Affairs, Quintiles

  • Legislative framework for pharmacovigilance in Europe
  • Principles on clinical safety reporting in Europe
  • Pharmacovigilance inspections in Europe
  • Safety reporting from clinical trials
  • Responsibilities
  • 9:50 CHANGES IN REGULATORY THINKING AND ACTIONS

  • Recent drug safety issues (Vioxx, Bextra & others)
  • Risk/Benefit: real vs perceived notions of "safe"
  • Impact of recent issues on regulatory thinking and evolving guidelines
  • Lessons learned - what will these changes mean to your safety commitments
  • Kenneth Hintze

    Kenneth Hintze, Senior Director, Global Safety & Pharmacovigilance , Kendle International

    10:30 Morning Coffee

    11:00 ROLE OF EUDRAVIGILANCE IN DRUG DEVELOPMENT

    Gurdyal Kalsi

    Gurdyal Kalsi, Director, Medical Affairs, MDS Pharma Services

    11:40 THE FDA’S ADVERSE EVENTS REPORTING SYSTEM

  • Tools for storing and analysing safety reports
  • International Conference on Harmonisation (ICH) safety reporting guidance
  • CDER and CBER - detecting safety signals and monitoring drug safety
  • Regulatory actions - improving product safety and protecting coding regulations
  • Health complications that involve the use of FDA regulated products
  • What is the true cost of drug-related adverse events?
  • Sven  Knudsen

    Sven Knudsen, Life Sciences Statistical Consultant, Insightful

    12:20 EFFECTIVE ADR AVOIDANCE

    Richard  Wyse

    Richard Wyse, Chairman, Economic Healthcare Associates

    12:40 Networking Lunch

    13:50 REPORTING ADVERSE EXPERIENCES FOR COMBINATION PRODUCTS: A WORK IN PROGRESS

    Mason Diamond

    Mason Diamond, Vice President, Clinical & Regulatory Affairs, TyRx Pharma

  • Combination products – what they are and who regulates them
  • FDA request for comments on adverse event reporting for combination products – September, 2005
  • Postmarketing reporting requirements for drugs, biologics and medical devices – how do they fit?
  • Issues facing the FDA and Industry in addressing this and implications for the EU
  • Status report – where we are right now
  • 14:30 AGGREGATE ADVERSE EVENT REPORTING AND DRUG SAFETY RISK MANAGEMENT TOOLS

  • Appreciate the project considerations, challenges and best practices surrounding the implementation of a safety data warehouse and/or data mart
  • Gain insight into how such tools have been successfully implemented and proved their worth
  • Discuss unsuccessful implementations, reasons for failure and mitigation strategies to bear in mind before considering a project of this nature
  • Drivers raising public awareness of drug safety
  • Proactive determinations of risk
  • John  Whitebrook

    John Whitebrook, UK Country Manager & Vice President Pharmaceuticals, Instrasphere Technologies

    Jennifer Markey

    Jennifer Markey, Vice President, Practice Management, Instrasphere Technologies

    15:10 Afternoon Tea

    15:40 COLLECTION, MANAGEMENT, DISTRIBUTION AND ANALYSIS OF SUSPECTED ADVERSE DRUG REACTION INFORMATION

    Simon Sparkes

    Simon Sparkes, Vice President, Global Sales & Marketing, Aris Global U K Limited

  • Safety case intake and handling
  • PSUR and ASR preparation
  • Signal detection
  • Electronic reporting
  • Benefit/Risk strategies
  • EU reporting requirements & the impact of volume 9A on pharmacovigilance systems
  • 16:20 GLOBAL ADVERSE EVENT REPORTING

    Livia Stankovics

    Livia Stankovics, Affliate Pharmacovigilance Head, Sanofi - Aventis

  • Japanese requirements
  • Understanding reports
  • Efficient use of reports
  • USA requirements
  • Assessing the seriousness and expectations of reports
  • European requirements
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Dr John  Ferguson

    Dr John Ferguson, Vice President, Pharmacovigilance, Millennium Pharmaceuticals

    9:10 SAFETY DATA REPORTING IN ELECTRONIC SUBMISSIONS

  • FDA requirements for source documents
  • Maintaining an audit trail
  • Building safety data sets
  • Tools for automating the E-submission process
  • Authoring the safety narratives
  • Submission assembly and QA
  • Guy Pawson

    Guy Pawson, Manager, Electronic Submissions, Genentech Inc

    9:50 SIGNAL DETECTION

    Dr Tjeerd-Pieter van Staa

    Dr Tjeerd-Pieter van Staa, Head, Research, General Practice Research Database, , Medicines & Healthcare products Regulatory Agency (MHRA)

  • The role of signal detection in optimising product safety
  • Risk/benefit evaluation - success is dependent on detection of signals
  • Various methods for signal detection - observations, case reports, individual reports or spontaneous reporting systems
  • Strength of signals – what signals are important?
  • The role of automated signal generation in pharmacovigilance
  • Should observational databases or patient registries be used for signal generation?
  • 10:30 Morning Coffee

    11:00 GLOBAL PRODUCT SAFETY

  • PV activities in clinical development programmes
  • Proactively assessing risk/benefit of a product during the clinical development programme
  • Proactively working with regulatory agencies to design and implement a post approval risk assessment programme
  • Designing, implementing and evaluating risk minimisation action plans
  • Routine safety signal alert, detection, management, documentation and reporting system
  • Sean Zhao

    Sean Zhao, Director, Global Safety, Pharmacovigilance, Amgen

    11:40 SAFETY RISK MANAGEMENT AND CLINICAL DEVELOPMENT

    Dr Joanna Haas

    Dr Joanna Haas, Vice President, Pharmacovigilance, Genzyme

  • Developing a problem oriented approach
  • Tracking safety issues from early development
  • Interface with ICHE2E and with FDA risk management guidance
  • Organisational and management challenges
  • 12:20 Networking Lunch

    13:50 RISK MANAGEMENT PRINCIPLES TO PHARMCOVIGILANCE

    Dr John  Ferguson

    Dr John Ferguson, Vice President, Pharmacovigilance, Millennium Pharmaceuticals

  • Applying risk management strategies to products in development
  • Risk management strategy development
  • Practical risk management applications for the pharmaceutical industry
  • Approaches in pre- and post-marketing risk assessment
  • EudraVigilance - one of the main opponents against risk
  • Crisis management - what to do if it goes wrong
  • 14:30 PV QUALITY ASSURANCE

    Brian Dinardo

    Brian Dinardo, Partner, Drug Safety Group

  • QC vs. QA
  • PV QA process overview -- a Six Sigma approach
  • Defining the quality plan – risk based quality assurance
  • Statistical sampling methods for PV QA
  • On-line and automated reviews
  • Root cause analysis and corrective action planning process and tools
  • 15:10 Afternoon Tea

    15:40 TOOLS TO HELP MINIMISE RISK IN PHARMACOVIGILANCE

  • ICH risk categories - concrete risk, contributory risk, hypothetical risk, unknown risk
  • Better use of tools to protect public health
  • The development and selection of measures to reduce risk
  • Monitoring of the effectiveness of risk control
  • Proactive strategies for risk management
  • Risk-benefit assessment
  • Fredrick  Bouder

    Fredrick Bouder, Research Associate, Kings Centre for Risk Management

    16:20 FUTURE OF PHARMACOVIGILANCE IN EUROPE

  • Compensation
  • How to improve the quality of pharmacovigilance data
  • Promoting industry competitiveness and competition
  • Reporting and networking for patient safety
  • Future direction of pharmacovigilance
  • Birgitt Gellert

    Birgitt Gellert, Drug Safety Manager, Bayer Vital GmbH

    17:00 Chairman’s Closing Remarks and Close of Day One

    +

    Mayfair Conference Centre

    17 Connaught Mews
    London W2 2EL
    United Kingdom

    Mayfair Conference Centre

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download


    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

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.