Drug Information Association Logo
Corporate Tagline

2nd Periodic Safety Update Report Information Day

Apr 29 2014 8:00AM - Apr 29 2014 5:00PM | European Medicines Agency Canary Wharf, 7 Westferry Circus London E14 4HB United Kingdom

« Back to Listing

Overview 

This Information Day provides a forum to discuss the implementation experience with PSURs under the new pharmacovigilance legislation from an EU, international regulators’ as well as pharmaceutical industries’ perspective. This will include the first practical experience with the recently started single PSUR assessment for centrally and nationally authoriszed medicinal products.

Specific aspects of the quality of PSURs in terms of assessment for public health and greater emphasis on meaningful evaluation of important new risk information in the context of a medicinal product’s benefits will be addressed.

Practical aspects in relation to the December 2013 updates of GVP module VII will be presented. Furthermore, an exchange on the ICH E2C (R2) guideline on the “Periodic Benefit/Risk Evaluation Report (PBRER)” will occur, where ICH experts will present highlights in relation to the supplemental E2C Q&A document.

Key functionalities of the new PSUR Repository to be audited will be outlined.

The audience is invited to submit specific questions to key topics via e-mail karin.gamba@diaeurope.org

What You Will Learn 

  • Implementation experience and questions based on the ICH E2C (R2) format and content
  • Benefit/risk evaluation in the context of PSUR assessments
  • Updates to GVP Module VII
  • Application of the EU reference date list for PSUR submissions
  • Submission requirements and procedural aspects of the PSUR single assessment procedure
  • PSUR Repository functionalities to be audited
  • EU regional requirements
  • Direct and binding product information updates

Who Should Attend 

This programme will benefit Qualified Persons Responsible for Pharmacovigilance (QPPVs) and individuals involved in:

  • Pharmacovigilance
  • Clinical Development
  • Regulatory Affairs
  • Information Management
  • Safety Databases

Contact Information 

DIA Europe
Kuechengasse 16
4051 Basel, Switzerland
Tel: +41 61 225 51 51
Fax: +41 61 225 51 52
E-mail: diaeurope@diaeurope.org

Hotel & Travel 

The National Union of Rail, Maritime and Transport Workers (RMT) has announced a strike from 21:00 on Monday, 28 April for 48 hours (until 21:00 on Wednesday, 30 April).

For the latest information on how to get around London on 29 April, please visit www.tfl.gov.uk

 

HOTEL INFORMATION
Attendees are kindly requested to make their own reservation. Recommended hotel close to the EMA:

Hilton London Docklands Riverside
265 Rotherhithe Street
London SE16 5HW

Tel: +44 20 7231 1001
Fax: +44 20 7231 0599
Email: reservations.docklands@hilton.com

Special negotiated DIA rate for participants of the Information Day is GBP 139.00 per single room incl. breakfast and VAT (GBP 149.00 for double occupancy). Please book your room at least 30 days before arrival through this link.
For reservations after that date, please contact Beatriz Martinez at: beatriz01.martinez@Hilton.com.  
The hotel is situated opposite of Canary Wharf conveniently connected by a shuttle boat. The landing stage is in walking distance to the EMA (2 min).

TRAVEL INFORMATION
The Information Day takes place at the

European Medicines Agency (EMA)
7 Westferry Circus
Canary Wharf
London E14 4HB, UK
Website: www.ema.europa.eu

Please click here for a map on how to find the EMA.
Please click here for some useful transport information.

For the special security access procedure to enter the EMA building, please calculate a delay of up to 10-15 minutes. It is not possible to enter the building before 8.00 am.

Faculty 

Previous Next

Agenda  

Day 1 Tuesday, April 29, 2014

  • 8:00AM - 8:30AM

    REGISTRATION
  • 8:30AM - 8:45AM

    WELCOME NOTE

    Speaker(s):

    • Peter Richard Arlett, MRCP
      Head of Pharmacovigilance Department
      European Medicines Agency, European Union, United Kingdom
  • 8:45AM - 10:15AM

    Session 1: Technical and procedural aspects of PSUR submissions and the PSUR single assessment


    Session Chair(s):

    • Heidi Janssen
      Head, Endocrinology, Metabolism & Cardiovascular
      European Medicines Agency (EMA), United Kingdom
    • Irene Rager
      Head of Service E, Procedure Management Department
      European Medicines Agency, United Kingdom

    This session will provide a detailed update on the technical and procedural aspects in relation to PSUR submissions and the PSUR single assessment. It will start with an overview of the PSUR/PSUSA assessed so far including statistics, type of outcome and challenges encountered. Other key areas addressed will include procedural aspects related to periodicity, submissions and the maintenance of the EURD list. The PSUR repository functionalities to be audited will be also summarised.

    Speaker(s):

    • An overview of the PSUR/PSUSA assessment experience so far
      Maria Boulos
      Scientific Administrator
      EMA, United Kingdom
    • Application of the EU reference date list for PSUR submissions
      Katerina-Christina Deli
      EMA, United Kingdom
    • Submission requirements and procedural aspects of the PSUR single assessment procedure
      Ana Zanoletty Perez
      Procedure Manager, Evaluation Procedures E
      EMA, United Kingdom
  • 10:15AM - 10:40AM

    COFFEE BREAK
  • 10:40AM - 11:40AM

    Session 1: Technical and procedural aspects of PSUR submissions and the PSUR single assessment


    Session Chair(s):

    • Heidi Janssen
      Head, Endocrinology, Metabolism & Cardiovascular
      European Medicines Agency (EMA), United Kingdom
    • Irene Rager
      Head of Service E, Procedure Management Department
      European Medicines Agency, United Kingdom

    This session will provide a detailed update on the technical and procedural aspects in relation to PSUR submissions and the PSUR single assessment. It will start with an overview of the PSUR/PSUSA assessed so far including statistics, type of outcome and challenges encountered. Other key areas addressed will include procedural aspects related to periodicity, submissions and the maintenance of the EURD list. The PSUR repository functionalities to be audited will be also summarised.

    Speaker(s):

    • PSURs for Nationally Authorised Products – Transitional and Future arrangements
      Anne M Ambrose
      Chairperson of the CMDh EU PSUR worksharing working party
      Medicines & Healthcare Products Regulatory Agency, United Kingdom
    • PSUR Repository and functionalities to be audited
      Kristiina Puusaari
      Human Medicines Evaluation
      EMA, United Kingdom
  • 11:40AM - 12:30PM

    Session 2: Practical implementation experience with the PBRER in the EU


    Session Chair(s):

    • Almath Spooner, PhD,RPh
      Pharmacovigilance and Risk Management Lead, IMB and Vice Chair, PRAC
      Irish Medicines Board, Ireland

    This session will focus on the experience of the implementation and operation of the ICH E2C (R2) guideline on the “Periodic Benefit/Risk Evaluation Report (PBRER)” from regulators’ and industry perspective.

    Speaker(s):

    • Experience with operation of the new PSUR assessment procedure at the PRAC
      Jolanta Gulbinovic
      Chief expert
      State Medicines Control Agency , Lithuania
    • Experience with operation of the new PSUR assessment procedure at Health Canada
      Christopher Turner, MD,FRCPC
      Director General
      Health Canada / EMA, Canada
  • 12:30PM - 1:15PM

    SANDWICH LUNCH
  • 1:15PM - 2:00PM

    Session 2: Practical implementation experience with the PBRER in the EU


    Session Chair(s):

    • Almath Spooner, PhD,RPh
      Pharmacovigilance and Risk Management Lead, IMB and Vice Chair, PRAC
      Irish Medicines Board, Ireland

    This session will focus on the experience of the implementation and operation of the ICH E2C (R2) guideline on the “Periodic Benefit/Risk Evaluation Report (PBRER)” from regulators’ and industry perspective.

    Speaker(s):

    • Experience with operation of the new PSUR assessment procedure at PMDA
      Yoshihiko Sano
      MHLW/PMDA Liaison Officer at European Medicines Agency
      EMA, United Kingdom
    • Reflections from a pharmaceutical industry perspective on the implementation and operation of the new PBRER format
      Laurent Auclert, MD
      Qualified Person Responsible for Pharmacovigilance (QPPV)
      Sanofi-Aventis R&D, France
  • 2:00PM - 3:30PM

    Session 3: Periodic Benefit Risk Evaluation Reporting in practice


    Session Chair(s):

    • Enrica Alteri, MD
      Head of Safety and Efficacy of Medicines
      European Medicines Agency, United Kingdom

    This session will focus on the main objectives of the PBRER with regard to the optimisation and effective use of medicines and will provide an overview of the expectations of the PRAC as regards the presentation of signals and the risk assessment. Practical suggestions on content optimisation will be highlighted from an industry perspective.

    Speaker(s):

    • Periodic Benefit Risk Evaluation Report – has it achieved what it set out to do?
      Almath Spooner, PhD,RPh
      Pharmacovigilance and Risk Management Lead, IMB and Vice Chair, PRAC
      Irish Medicines Board, Ireland
    • Presenting signal evaluations and presenting risk assessments in the PBRER – interdependencies with signal management
      Menno Van Der Elst, PharmD,PhD
      Alternate PRAC member
      Medicines Evaluation Board, Netherlands
    • Practical suggestions to optimise content: industry perspective
      Valerie E. Simmons, MD,FFPM
      EU QPPV, Executive, Global Patient Safety
      Eli Lilly and Company Ltd, United Kingdom
  • 3:30PM - 4:00PM

    COFFEE BREAK
  • 4:00PM - 5:00PM

    Session 3: Periodic Benefit Risk Evaluation Reporting in practice


    Session Chair(s):

    • Enrica Alteri, MD
      Head of Safety and Efficacy of Medicines
      European Medicines Agency, United Kingdom

    This session will focus on the main objectives of the PBRER with regard to the optimisation and effective use of medicines and will provide an overview of the expectations of the PRAC as regards the presentation of signals and the risk assessment. Practical suggestions on content optimisation will be highlighted from an industry perspective.

    Speaker(s):

    • Periodic Benefit Risk Evaluation Reporting: industry perspective
      Klaudija Marijanovic Barac
      Drug Safety Associate
      Pliva - Research & Development Ltd., Croatia (Hrvatska)
    • Exposure, off-label use, benefit evaluation – what is expected by the PRAC
      Representative Invited
      MHRA

Registration Fees 

Other Fees

Charitable Nonprofit/Academia
€180.00
Government (Full Time)
€180.00
Industry
€365.00
Register Online

CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

  • Industry (Member/Non-member) = €200.00
  • Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
  • Tutorial cancellation: €50.00

If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

« Back to Listing Back To Top