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The practice of Pharmacovigilance is now more necessary than ever. With the sharp increase in product recalls and litigation cases in recent years, the need for the Pharmaceutical industry to scrutinise each of its new drugs activity and effects has become of paramount importance. 

The potential problems arising from a lack of proper compliance to correct Pharmacovigilance procedures can be catastrophic, ranging from patient sickness and death, to significant damage to a companies financing and reputation.

 

Also running is a post-conference workshop on Wednesday 16th March, 2011

8.30am - 1.30pm - Optimizing Pharmacovigilance in Affiliates

Hosted by; Katja Kusche, Global Head of Safety Science for Mature Product, Hoffmann-La Roche

 

 

Key topics under discussion include;

  • Practical issues in PhV inspections - With case studies presented
  • Periodic safety reporting during clinical development and the DSUR
  • Risk Management and internal auditing strategies
  • Advances in Signal Detection
  • A panel discussion on 'The impact of new legislation on pharmacovigilance activities and the global harmonisation of new regulations’
  • Improved pharmacovigilance reporting system for effective drug safety management
pharmacovigilance

 

 

You should attend this event if you have responsibilities in the following areas;

 

  • Pharmacovigilance
  • Pharmacoepidemiology
  • Pharmacogenomics
  • Drug/Product Safety
  • Drug Development
  • Information and Clinical Data Management
  • Clinical Pharmacology
  • Clinical Safety
  • PSUR
  • Risk Management
  • Research & Development
  • Quality Assurance
Pharmacovigilance

 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Peter Schiemann

Peter Schiemann, Global Head of Quality Risk Management, Roche Pharma

9:10 PRACTICAL ISSUES IN PHARMACOVIGILANCE INSPECTIONS

Mechthild Waldeyer

Mechthild Waldeyer, Drug Safety Management, medac GmbH

  • Case study: A 2010 MHRA PhV Inspection in Stirling, Scotland
  • Internal and external communication
  • Obstacles, surprises, practical recommendations
  • Expenditure of time and costs
  • The importance of team work
  • Be calm and keep your sense of humour!
  • 9:50 QUALITY RISK MANAGEMENT AS THE QUALITY MANAGEMENT PRINCIPLE

    Peter Schiemann

    Peter Schiemann, Global Head of Quality Risk Management, Roche Pharma

  • What are regulators expecting from a Quality Management System?
  • Quality Management in Pharmacovigilance - How is it done?
  • Preparing for the challenge of risk based inspections
  • 10:30 Morning Coffee

    11:00 MANAGING CLINICAL SAFETY WHEN MANUFACTURING EXPERIENCES SIGNIFICANT GLITCHES

    Glyn Belcher

    Glyn Belcher, Vice President Drug Safety and Risk Management, Biogen Idec

  • Safety monitoring of medicines
  • Implementing an effective response action plan
  • Case studies
  • 11:40 INSPECTIONS... ARE YOU READY?

    Joanne Webbe

    Joanne Webbe, Associate Director, Drug Safety & Public Health, Gilead Sciences

  • Background to inspections
  • Pharmacovigilance inspections scope
  • Common inspection findings
  • Inspection preparation so you are inspection ready
  • 12:20 Networking Lunch

    13:20 PREPARING FOR AND SURVIVING PV INSPECTIONS

    Mary O'Hare

    Mary O'Hare, Section Director, AstraZeneca

  • Personal inspection experience
  • Review the experience of an MHRA PV Inspection
  • Share what went well and what could be improved
  • Dealing with the aftermath
  • Differences between an MHRA and FDA inspection
  • 14:00 PANEL DISCUSSION

     

    '‘The impact of new legislation on pharmacovigilance activities and the harmonisation of new regulations'

    Stewart Geary

    Stewart Geary, Regional Safety Director, Eisai

    Glyn Belcher

    Glyn Belcher, Vice President Drug Safety and Risk Management, Biogen Idec

    Catarina Macedo

    Catarina Macedo, Pharmacovigilance Manager, Cancer Research UK

    15:00 Afternoon Tea

    15:30 PERIODIC SAFETY REPORTING DURING CLINICAL DEVELOPMENT AND THE DSUR

    Stewart Geary

    Stewart Geary, Regional Safety Director, Eisai

  • Purpose and rationale for periodic reporting during clinical development
  • Current regulations for periodic reporting during clinical development:
  • The US IND Annual Report, European Annual Safety Report and Japanese 6-monthly Periodic Report During Development
  • ICH E2F and the DSUR
  • The challenges for preparing the DSUR
  • 16:10 ROLES AND RESPONSIBILITIES OF SPONSER AND STUDY SITE IN ADVERSE EVENT REPORTING

    Rhoda Molife

    Rhoda Molife, Physician, Institute of Cancer Research

  • Who should do what and when
  • Complexity of patients 'v' rigid nature of adverse event reporting
  • Limitations of SAE reporting forms
  • 16:50 THE DRAFT ABPI PHARMACOVIGILANCE EXPERT NETWORK GUIDANCE NOTES FOR PHARMACOVIGILANCE IN PATIENT SUPPORT PROGRAMMES

    Esteban Herrero-Martinez

    Esteban Herrero-Martinez, Regulatory Manager, ABPI

  • Reasons for developing the guidance notes
  • Background information on Patient Support Programmes (PSPs)
  • Reactive and proactive approaches in PSPs
  • Recommendations relating to documentation requirements
  • Adverse event collection and reporting requirements
  • 17:30 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-Registration & Coffee

    9:00 Chairman's Opening Remarks

    Catarina Macedo

    Catarina Macedo, Pharmacovigilance Manager, Cancer Research UK

    9:10 DRUG SAFETY IN EARLY PHASE ONCOLOGY TRIALS - CASE STUDIES

    Catarina Macedo

    Catarina Macedo, Pharmacovigilance Manager, Cancer Research UK

  • A non-commercial sponsor’s perspective
  • Early phase oncology trials in patients
  • Recurring themes in case studies:
  • Underlying illness vs. Disease progression vs. Safety signals
  • IMP quality issue with an impact on safety
  • Dealing with independent expert reviews
  • Internal decision making processes and communication
  • 9:50 OPTIMIZING THE CLINICAL SAFETY CONTRIBUTION TO THE MANAGEMENT OF MANUFACTURING QUALITY ISSUES

    Barbara Donner

    Barbara Donner, Global Head of Safety Science Business Support, Hoffmann-La Roche

  • Approach form medical assessments for product complaints possibly impacting patient’s safety
  • Challenges for Clinical Safety
  • Organizational structure to allow high quality medical assessments
  • Monitoring the safety database for events which may result from product defects
  • 10:30 Morning Coffee

    11:00 RISK MANAGEMENT – WHAT ARE WE LEARNING?

    Deborah Layton

    Deborah Layton, Principal Research Fellow , Drug Safety Research Unit

  • Relationship between safety specification and risk management
  • Developing strategies to answer relevant questions
  • Managing the stakeholders
  • 11:40 MANAGING BENEFIT/RISK FOR MATURE MEDICINES: A CASE STUDY

    Katja Kusche

    Katja Kusche , Safety Science Global Head Mature Products, Hoffmann-La Roche

  • Mature products' BR can be challenged after decades on the market
  • External researches generating new data and hypotheses
  • Poor quality data in house: Case data from spontaneous reporting and 'historic' dossiers
  • Lack of expertise - Need to reach out to experts in the disease area
  • Limited awareness of the needs for continued support of these products in a development organisation
  • resource constraints while health authority expectations and demands are growing
  • 12:20 Networking Lunch

    13:20 ADVERSE EVENT(S) REPORTING FROM A NON-CLINICAL SAFETY PERSPECTIVE

    George McCormick

    George McCormick, Vice President, Cephalon

  • Relationship between safety specification and risk management
  • What constitutes the necessity to report Adverse Events / Serious Adverse Events (SAE) / Adverse Drug Reactions (ADR) clinically
  • Non-clinical safety assessment in support of clinical safety
  • Traditional endpoints in non-clinical safety testing
  • Predictability of non-clinical safety (animal safety testing) results to drug/chemical-induced safety in humans
  • Classification of toxicities that may be expected during the course of toxicology testing
  • Non-clinical adverse events reporting to domestic and international regulatory agencies 
  • 14:00 PHARMACOVIGILANCE IN PROMOTION: NECESSITY OR ARGUMENT?

    Michele Sangeleer

    Michele Sangeleer, Pharmacovigilance Manager, Eli Lilly Benelux

  • The legal and deontological requirements for fair safety info in informational/promotional materials for HCPs (including timelines)
  • The challenges of wording and presentation
  • The role of the QPPV and the legal responsible for material review: How far do they have to go?
  • The DDLs and risk management activities integrated in promotion
  • The reaction of European customers (HCP, patients, etc) to safety information
  • 14:40 Afternoon Tea

    15:10 SIGNAL DETECTION IN THE UK

    Shelley Gandhi

    Shelley Gandhi, Unit Manager-Signal Management Group, MHRA

  • Challenges faced by Signal Management systems
  • The tools used for Signal data management at MHRA?
  • Signal Evaluation and Prioritisation
  • Is data quality important for signal generation?
  • What are the future challenges in this area?
  • 15:50 MANAGEMENT OF SAFETY DATA FROM RELATED RESEARCH ACTIVITIES

    Heide Cunning

    Heide Cunning, Director, Safety Operations, Ortho-McNeil Janssen Scientific Affairs

  • Registration of clinical activities in a company tracking database
  • Minimum requirements for safety data collection
  • Vendor contract and the program protocol/description (if applicable) will contain the applicable safety language
  • Vendor safety training
  • 16:30 Chairman’s Closing Remarks and Close of Day Two

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    Workshops

    Optimizing Pharmacovigilance in Affiliates
    Workshop

    Optimizing Pharmacovigilance in Affiliates

    Copthorne Tara Hotel
    16th March 2011
    London, United Kingdom

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    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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