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Impact of the New Pharmacovigilance Legislation on Regulatory Affairs

Jun 4 2013 9:00AM - Jun 5 2013 4:00PM | NH Harrington Hall 5-25 Harrington Gardens London SW7 4JB United Kingdom

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Overview 

This two day conference will focus on the impact of the new Pharmacovigilance legislation on regulatory affairs, from various perspectives. The changes in legislation will affect the way product assessment is carried out in both pre- and post-authorisation phases, introduce new obligations to Marketing Authorisation Holders, and bring in continuous benefit risk assessment. This important conference will also be looking at the impact of the new Pharmacovigilance Risk Assessment Committee (PRAC) on the life-cycle management of products and the PRAC’s interactions with other Committees.

Who Should Attend 

This conference is aimed at intermediate and experienced professionals from

  • Regulatory agencies
  • The pharmaceutical industry and service providers
  • Academic institutions

including

  • Regulatory affairs personnel
  • Pharmacovigilance staff
  • Quality assurance personnel for pharmacovigilance and pharmacovigilance inspectors
  • Clinical and medical personnel
  • Project managers in drug development

Learning Objectives 

  • To provide insight into the regulatory requirements, scientific and operational challenges associated with the implementation of the New Pharmacovigilance Legislation
  • Attendance will offer opportunities to exchange experiences and hear from the regulators directly about how different aspects of the new legislation will be implemented

Special Offers 

Group Discounts Available – Send 3 participants and the 4th is free!

Conditions apply. Online registration not available for this offer. Call DIA in Europe on +41 61 225 51 51 or email for further information.

Hotel & Travel 

DIA has blocked a limited number of rooms at the following hotel:

NH Harrington Hall Hotel
5-25 Harrington Gardens
South Kensington, London SW7 4JW
UK

Tel.: +44 207 396 96 96
Fax: +44 207 398 46 61
Email: bookings@nh-hotels.com

At the special rate of GBP 180.00 per room/night inclusive of breakfast and VAT.

In order to make a reservation, please contact the hotel directly: bookings@nh-hotels.com or by phone: +44 870 735 0358.

Please quote the booking reference (group name and code)

Group name: DIA

Group code: 19429982

The special room rate will be available until 4 May 2013 or until the group block is sold-out, whichever comes first.

Cancellation policy: In case of no-show or late cancellation the costs will be charged onto your credit card. Once your booking is confirmed, the individual cancellation policy will be 7 days prior to arrival.

Contact Information 

DIA Europe

KUECHENGASSE 16, POSTFACH

4002 BASEL

SWITZERLAND

 

TEL.: +41 61 225 51 51

FAX: +41 61 225 51 52

E-MAIL: DIAEUROPE@DIAEUROPE.ORG

Program Committee 

Previous Next

Agenda  

Day 1 Tuesday, June 04, 2013

  • 9:30AM - 11:00AM

    FUNDAMENTALS - THE ROLE OF PRAC & CMD (h)


    Session Chair(s):

    • Emma Louise Du Four, MBA
      Senior Director, Regulatory Policy & Intelligence
      Abbvie, United Kingdom

    Speaker(s):

    • PRAC - General overview including membership, working procedures and transparency
      Speaker Invited
      Switzerland
    • How will CMD (h) will interact with the PRAC
      Peter Bachmann, DrSc
      Senior Expert; Chair, Coordination Group for Mutual Recognition and Decentralise
      Federal Institute for Drugs and Medical Devices, Germany
  • 11:30AM - 1:00PM

    NEW FEATURES OF THE PHARMACOVIGILANCE LEGISLATION AND THEIR IMPACT ON REGULATORY ACTIVITIES


    Session Chair(s):

    • No-image Angelika Joos, MPharm
      Executive Director, Regulatory Policy, EU and Most of World
      Merck Sharp & Dohme Inc., Belgium

    Speaker(s):

    • Requirements for PASS Including Article 22 Joint Protocols and Registries
      Speaker Invited
      Switzerland
    • PAES, Annual Review of Conditions and Renewal
      Speaker Invited
      Switzerland
    • Monitoring (Black Symbol) and Change in Scope of Drugs
      Speaker Invited
      Switzerland
  • 2:00PM - 3:30PM

    NEW PV LEGISLATION AND HOW IT IS IMPACTING DRUG DEVELOPMENT


    Session Chair(s):

    • Katrin Rupalla, PhD
      Vice President
      Bristol-Myers Squibb Company , France

    Speaker(s):

    • How Does the New PV Legislation Impact the Drug Development and Pre-Approval Phase from the EMA Perspective?
      Andrea Laslop
      Head of Unit
      AGES PharmMed - the Austrian medicines agency, Austria
    • How Does the New PV Legislation Impact the Drug Development and Pre-Approval Phase from the Industry Perspective?
      Katrin Rupalla, PhD
      Vice President
      Bristol-Myers Squibb Company , France
    • How Do these Elements Impact the Approval and Post-Approval-Phase from the Industry Perspective
      Angelika Joos, MPharm
      Executive Director, Regulatory Policy, EU and Most of World
      Merck Sharp & Dohme Inc., Belgium
  • 4:00PM - 5:00PM

    WHAT IS NEXT IN 2013?


    Session Chair(s):

    • Zaide Frias, PharmD
      Head of Regulatory Affairs
      European Medicine Agency, United Kingdom

    Speaker(s):

    • Industry experience with Amendments to the PV legislation
      Anne-Marie de Ferran
      Head of the Pharmacovigilance Quality & Compliance - Global PhV and Epidemiology
      Sanofi, France
    • XEVMPD and Future of Art 57 (2)
      John W. Kiser, MSc
      Senior Director, Regulatory Operations
      Abbvie, United States

Day 2 Wednesday, June 05, 2013

  • 8:30AM - 10:00AM

    INVOLVEMENT OF TWO SETS OF RAPPORTEURS IN THE PROCEDURES AND IMPACT ON REGULATORY AFFAIRS


    Session Chair(s):

    • No-image Peter Bachmann, DrSc
      Senior Expert; Chair, Coordination Group for Mutual Recognition and Decentralise
      Federal Institute for Drugs and Medical Devices, Germany

    Speaker(s):

    • Marketing Authorisation Application and post-approval phase - Working with two sets of rapporteurs from the EMA perspective
      Speaker Invited
      Switzerland
    • Marketing Authorisation Application and post-approval phase - Working with two sets of rapporteurs from the CHMP perspective
      Speaker Invited
      Switzerland
    • Industry Experience - Working with two sets of rapporteurs
      Speaker Invited
      Switzerland
  • 10:30AM - 12:00PM

    NEW PV LEGISLATION AND THE OPPORTUNITIES FOR REGULATORY AFFAIRS


    Session Chair(s):

    • Isabelle Clamou
      Director
      EFPIA, Belgium

    Speaker(s):

    • Adaptive Licensing: Overview of initiatives and status
      Speaker Invited
      Switzerland
    • Data Elements around Adaptive Licensing and Which Tools of the New PV Legislation Could be Used
      Andrea Laslop
      Head of Unit
      AGES PharmMed - the Austrian medicines agency, Austria
    • Potential Pilot Projects – What could this look like?
      Anton Hoos, DrMed,MD,MBA
      Senior Vice President, European Medical Affairs
      Glaxosmithkline, United Kingdom
  • 1:00PM - 2:30PM

    REFERRALS, OPINIONS AND CONDITIONS


    Session Chair(s):

    • Anu M Tummavuori-Liemann
      -
      -, Switzerland

    Speaker(s):

    • Referral Procedures: Art 20, 31 and UUP (107i), public hearings from the EMA perspective
      Speaker Invited
      Switzerland
    • Referral Procedures: Art 20, 31 and UUP (107i), public hearings from the PRAC perspective
      Sabine Straus, MD
      Head of Pharmacovigilance
      Medicines Evaluation Board, Netherlands
    • Referral Procedures from the CMDh Perspective
      Peter Bachmann, DrSc
      Senior Expert; Chair, Coordination Group for Mutual Recognition and Decentralise
      Federal Institute for Drugs and Medical Devices, Germany
    • Article 20: Recent industry experience with procedures
      Ian Hawkins
      Celgene Europe Ltd., United Kingdom
  • 3:00PM - 4:00PM

    PANEL DISCUSSION ON IMPACT ON DRUG DEVELOPMENT AND APPROVAL


    Session Chair(s):

    • Isabelle Clamou
      Director
      EFPIA, Belgium

Exhibits  

DIA is not offering exhibition for this meeting. For more information on exhibition opportunities in 2013 please contact: Roxann Schumacher, DIA Exhibits Manager on +41 61 225 51 38 or email: roxann.schumacher@diaeurope.org

Registration Fees 

Other Fees

Subevent Only Rate
€0.00

Member

Member Academia
€683.00
Member Government
€683.00
Member Standard
€1365.00
Member One-Day
€819.00
One Day Rate
€410.00
One Day Rate
€410.00

Non-Member

NonMember Academia
€798.00
NonMember Government
€798.00
NonMember Standard
€1480.00
One Day Rate
€525.00
One Day Rate
€934.00
One Day Rate
€525.00
Register Online

CANCELLATION POLICY: All cancellations must be made in writing and be 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.

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