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Pharmacovigilance

SAE Media Group are proud to present their 3rd annual conference on Pharmacovigilance due to take place in Central London over the 1st & 2nd July 2013. A year after the introduction of the new Pharmacovigilance legislation was enforced SAE Media Group take a look back at the successes and failures in the first year of its implementation. With concerns occurring across the board in relation to PV auditing, companies face the challenge of understanding the key considerations when presenting to auditors. Unravel the challenges in compiling and presenting the new PSUR to external regulatory bodies and determine what these regulatory bodies have learnt in the wake of its recent introduction.

The introduction of the new legislation has led to a significant change in how companies present there data and safety studies to external regulatory bodies. This has ultimately led to a lack of understanding in what is expected upon data presentation. Attend this fantastic forum to discuss the format and content of Periodic Safety Update Reports and how data integration and additional modules are incorporated into this documentation to provide a far more comprehensive overview of a drugs safety and efficacy. Join SAE Media Group as they look tackle these issues and many more at a summit that promises to be a must see event.

FEATURED SPEAKERS

Amer Alghabban

Amer Alghabban

Global Director Research & Development and Good Vigilance Practice Quality Assurance, Abbott Pharmaceuticals

Amer Alghabban

Global Director Research & Development and Good Vigilance Practice Quality Assurance, Abbott Pharmaceuticals
Amer Alghabban

Derek Woodcock

Pharma Consultant, Crossoak Pharma
Derek Woodcock

Doris Stenver

CMO, Danish Health and Medicines Authority
Doris Stenver

Garry Flounders

Pharmacovigilance Manager, Genzyme Therapeutics
Garry Flounders

Graeme Ladds

Director, pharsafer associates
Graeme Ladds

Graeme Ladds

Director, PharSafer Associates
Graeme Ladds

Iva Novak

Pharmacovigilance Auditor, TEVA Pharmaceuticals
Iva  Novak

John Talbot

Senior Lecturer, Pharmacovigilance, University of Hertfordshire
John Talbot

Joseph Kim

Senior Director Analytics and Signal Management, Quintiles (UK) Ltd
Joseph Kim

Keith Cormack

Pharmacovigilance Director/EU QPPV, Diamond PV Services
Keith Cormack

Maguire Andrew

Director of Global Epidemiology, and detection analysis, OXON Epidemiology
Maguire Andrew

Martin Holm-Peterson

Global Safety/ IT and Quality Coordination, Novo Nordisk
Martin Holm-Peterson

Michael Bean

Senior Director, Johnson and Johnson
Michael Bean

Nawab Qizilbash

Clinical Epidemiologist and Head, OXON Epidemiology
Nawab Qizilbash

Nele Matthijs

PhV Inspector, DG Inspection, Federal Agency for Medicines and Health Products
Nele Matthijs

Peter De Veene

EU Qualified Person for Pharmacovigilance, Roche
Peter De Veene

Sarah Derry

Associate Director, Diamond PV Services
Sarah Derry

Shelley Gandhi

Director, Pharmacovigilance and Drug Safety, NDA Group
Shelley Gandhi

William Long

Partner, sidley austin
William Long

Conference agenda

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8:30

Registration & Coffee

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9:00

Welcome and Introductions

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9:10

Implementation of Quality in Pharmacovigilance activities

  • The legislation requirements
  • Checks made by the EMA
  • Pharmacovigilance Inspections
  • The EU QPPV and Quality
  • PV System Master File and Quality
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    10:10

    Case Study- Links between regulatory and PV

  • How important are communications between Regulatory and PV teams within a company?
  • Break-downs in communication
  • Urgent Safety Variations
  • Routine safety ammendments
  • Product list maintenance
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    11:00

    The new PBRER's

  • The set up under the new regulations
  • Old style PSUR's to PBRER's- presentation versus analysis
  • Safety reviews and PBRER's
  • Open and closed signals-where do they go?
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    12:10

    Discussion session

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    12:30

    Close of Workshop

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Keith Cormack

    Keith Cormack, Pharmacovigilance Director/EU QPPV, Diamond PV Services

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    9:10

    How to qualify for quality and be audit ready

    Nele Matthijs

    Nele Matthijs, PhV Inspector, DG Inspection, Federal Agency for Medicines and Health Products

  • Focus on changes on audits since July 2012
  • Audit/inspection rules and requirements
  • Examples of PhV deficiencies
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    9:50

    PhV audits & Inspections in the light of the new GVP modules

    Iva  Novak

    Iva Novak, Pharmacovigilance Auditor, TEVA Pharmaceuticals

  • The audit plan
  • How PhV audits are affected by the new legislations
  • PhV audits  & PSMF
  • Audits and inspection findings
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    10:30

    Morning Coffee

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    11:00

    Guidance on UK Data Protection in post Marketing Pharmacovigilance

    William Long

    William Long, Partner, sidley austin

  • To explain the new UK Guidance on Data Protection and PV
  • To give an understanding of background to EU data protection and PV
  • To describe the development of the UK guidance
  • To provide an outline of the scope and main elements of the UK Guidance
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    11:40

    New EU GVP Guidelines: From Quality Assurance to Quality System

    Amer Alghabban

    Amer Alghabban, Global Director Research & Development and Good Vigilance Practice Quality Assurance, Abbott Pharmaceuticals

  • From Quality assurance to a complete Quality System
  • Parallelism between ISO and EU GVP Guidelines
  • Good PhV CAPA Practices: Assuring efficiency & mitigating future risks
  • Lessons learnt or not
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    12:20

    Networking Lunch

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    13:40

    Methods for Quantitative benefit risk assessment “BRA”

    Maguire Andrew

    Maguire Andrew, Director of Global Epidemiology, and detection analysis, OXON Epidemiology

  • Part 1:
    1. Review of methids and the rationale
    2. Explaining MCDA and an example of its application
  • Part 2
    1. The use of simulation and why it might fill the gaps
    2. Use of databases for BRA
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    14:20

    Managing benefit/risk for mature medicines: A case study

    Peter De Veene

    Peter De Veene, EU Qualified Person for Pharmacovigilance, Roche

  • Mature products' Benefit-risk can be challenged after decades on the market
  • External reseraches generating new data hypotheses
  • porr quality data in house: case data from spontanious reporting in historic dossiers
  • Lack of expertise- Need to recah 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
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    15:00

    Afternoon Tea

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    15:20

    Potential Role of Text Mining in Pharmacovigilance

    Joseph Kim

    Joseph Kim, Senior Director Analytics and Signal Management, Quintiles (UK) Ltd

  • Appreciating the need to evaluatte both structured and unstructured data in pharmacovigilance
  • Using text mining for signal detection: is it a reality?
  • Applying text mining to improve the quality of pharmacovigilance databases
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    16:00

    Data integration in Safety: Learn of the initiative that OXON is leading with EMA regulators and pharmacoepidemiologists in ENCePP

    Nawab Qizilbash

    Nawab Qizilbash, Clinical Epidemiologist and Head, OXON Epidemiology

  • Need for data integration for safety and benefit-risk analysis
  • Types of data integration
  • Differences in meta-analysis of trials and epidemiological studies
  • Current discussions within ENCePP at the EMA
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    16:40

    Panel Discussion: How has the new PV legislation impacted my company?

    Derek Woodcock

    Derek Woodcock, Pharma Consultant, Crossoak Pharma

    Keith Cormack

    Keith Cormack, Pharmacovigilance Director/EU QPPV, Diamond PV Services

    Peter De Veene

    Peter De Veene, EU Qualified Person for Pharmacovigilance, Roche

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    17:20

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Nawab Qizilbash

    Nawab Qizilbash, Clinical Epidemiologist and Head, OXON Epidemiology

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    9:10

    RMPs in the EU

    John Talbot

    John Talbot, Senior Lecturer, Pharmacovigilance, University of Hertfordshire

  • Requirements for EU RMP's (Module V)
  • Determinig the risk management strategy for the product
  • Experience with EU RMP's from 2 surveys
  • Assessing the effectiveness of risk management activities
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    9:50

    New pharmacovigilance legislation - an adequate response to current challenges?

    Doris Stenver

    Doris Stenver, CMO, Danish Health and Medicines Authority

  • Pharmacovigilance characteristics past and present
  • First experiences in the Pharmacovigilance Risk Assessment Committee
  • Status on implementation of the new legislation
  • Transparency initiatives- do they make a difference?
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    10:30

    Morning Coffee

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    11:00

    Improved pharmacovigilance reporting system for effective drug safety management

    Michael Bean

    Michael Bean, Senior Director, Johnson and Johnson

  • The benefits of an adequate IT solution to drug safety management
  • The importance of implementing a standardised data management system
  • Regulatory requirements
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    11:40

    The Pharmacovigilance system master file – harvesting the benefits

    Martin Holm-Peterson

    Martin Holm-Peterson, Global Safety/ IT and Quality Coordination, Novo Nordisk

  • PSMF's industry challenges
  • Key impacts of this new document
  • How the benefits in pharmacovigilance operations can be harvested
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    12:20

    Networking Lunch

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    13:30

    The Pharmacovigilance System Master File (PSMF)

    Derek Woodcock

    Derek Woodcock, Pharma Consultant, Crossoak Pharma

  • Registration and Maintenance
  • Structure and content
  • The PSMF, the PV system and the QPPV
  • Possible inspection findings
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    14:10

    Exerting Quality into Safety processes

    Graeme Ladds

    Graeme Ladds, Director, pharsafer associates

  • Induction training for new employees
  • ICSR's and errors in the data processing chain
  • Continuous improvement cycles
  • The difference between acceptance and accuracy
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    14:50

    Afternoon Tea

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    15:30

    Understanding the New PSUR Format

    Sarah Derry

    Sarah Derry, Associate Director, Diamond PV Services

  • Objectives of the new PSUR
  • Collation of data
  • Differences between the old and the new format
  • The European Union Reference Database List
  • PSURs for Generic, well established use, traditional herbal and homeopathic medicinal products
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    16:10

    Impact of the new PV Legislation

    Shelley Gandhi

    Shelley Gandhi, Director, Pharmacovigilance and Drug Safety, NDA Group

  • Summary of the new EU Pharmacovigilance legislation
  • Risk management and pharmacovigilance role of new PRAC
  • Risk minimization activities, including the impact from the new legislation
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    16:50

    Chairman’s Closing Remarks and Close of Day Two


    Pharmacovigilance Director/EU QPPV
    Diamond PV Services
    CMO
    Danish Health and Medicines Authority
    Senior Director
    Johnson and Johnson
    Global Safety/ IT and Quality Coordination
    Novo Nordisk
    Pharma Consultant
    Crossoak Pharma
    Director
    pharsafer associates
    Associate Director
    Diamond PV Services
    Director, Pharmacovigilance and Drug Safety
    NDA Group
    PhV Inspector, DG Inspection
    Federal Agency for Medicines and Health Products
    Pharmacovigilance Auditor
    TEVA Pharmaceuticals
    Global Director Research & Development and Good Vigilance Practice Quality Assurance
    Abbott Pharmaceuticals
    Clinical Epidemiologist and Head
    OXON Epidemiology
    EU Qualified Person for Pharmacovigilance
    Roche
    Director of Global Epidemiology, and detection analysis
    OXON Epidemiology
    Senior Director Analytics and Signal Management
    Quintiles (UK) Ltd
    Senior Lecturer, Pharmacovigilance
    University of Hertfordshire
    Pharmacovigilance Manager
    Genzyme Therapeutics
    Director
    PharSafer Associates
    Partner
    sidley austin

    Workshops

    From Signals to Risk Management/Minimisation

    From Signals to Risk Management/Minimisation

    Copthorne Tara Hotel
    3 July 2013
    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, SAE Media 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@saemediagroup.com

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