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SMi 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 SMi 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 SMi as they look tackle these issues and many more at a summit that promises to be a must see event.

2012-2013 can be seen as year of significant change with regards to Pharmacovigilance practices and this topic has never been more of a focus for Pharmaceutical companies across the board. SMi always seek to provide the timeliest and important information and this event is no exception. Here are just a few testimonials from our Inaugural Pharmacovigilance Conference:

 

 

"Very Good" - Mundipharma
"This was a very good conference"- Teva Pharmaceuticals
“Good Speakers”- PAREXEL international

 

 

Understand the main points to consider when presenting a PSUR to external regulatory bodies.
Tackle the issues and importance of adverse event reporting.
Discuss the importance of pharmacoepidemiology and what can be learnt from global trends.
Assess the benefits and challenges involved with outsourcing pharmacovigilance processes.
• Listen to case studies from companies that have undergone recent pharmacovigilance auditing and what was expected.
 

SMi's Pharmacovigilance event is a must attend for the following:

Pharmacovigilance Team Leader

Drug Safety Officer

Global Drug Safety Officer

Pharmacogilance Manager

Head of Safety and Pharmacovigilance

Pharmacovigilance Consultants

International PV auditors

Senior Safety Specialist

QPPV personnel

Regulatory affairs Associates

Regulatory Affairs Manager

Lead Safety Scientist 

 

Abbott Labotarories Ltd; AESEG (Association Espanola de fabricantes de Sustancias y Especialidades Farmaceuticas Genericas); Alexion Pharma UK; Arcondis GmbH; Asthma Uk; Basilea Pharmaceutica A G; Boehringer-Ingelheim; British Lung Foundation; Celgene Ltd; Cognizant Technology Solutions UK Ltd; Creation Healthcare; Creation Interactive; Doctors.net.uk; Edinburgh Bioquarter; EffRx Pharmaceuticals S.A.; EFPIA; Elan Pharma (Ireland) Ltd; Eli Lilly and Company; Gary Monk; Gedeon Richter Ltd; HealthUnlocked; N A P P Pharmaceutical; NHS Choices ; Novo Nordisk Inc; Oncology Pharma Ltd; Pfizer Inc; PharmaPhorum; Prosensa; Roche; ROCHE FARMA, S.A.; SAUDI FOOD AND DRUG AUTHORITY; Semantelli Corp; TNS Global; University Of Birmingham;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Keith Cormack

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

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
  • 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
  • 10:30 Morning Coffee

    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
  • 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
  • 12:20 Networking Lunch

    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
  • 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
  • 15:00 Afternoon Tea

    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
  • 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
  • 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

    17:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Nawab Qizilbash

    Nawab Qizilbash, Clinical Epidemiologist and Head, OXON Epidemiology

    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
  • 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?
  • 10:30 Morning Coffee

    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
  • 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
  • 12:20 Networking Lunch

    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
  • 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
  • 14:50 Afternoon Tea

    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
  • 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
  • 16:50 Chairman’s Closing Remarks and Close of Day Two

    +

    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

    Workshops

    From Signals to Risk Management/Minimisation
    Workshop

    From Signals to Risk Management/Minimisation

    Copthorne Tara Hotel
    3rd 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, 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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