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Clinical Trials Workshop II - Translating the New Transparency Requirements into Practice

Sep 24 2014 8:00AM - Sep 25 2014 5:30PM | Millennium Gloucester Hotel London Kensington 4-18 Harrington Gardens London SW7 4LH United Kingdom

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Overview 

New EU requirements are expected to come into force during 2014, impacting clinical trial processes including informed consent as well as the provision of public access to information and results of clinical trials. This workshop will review the new transparency requirements and voluntary commitments and, describe how these will impact current disclosure procedures. There will be a focus on sharing experiences on how the requirements are being implemented in practise.

The two day workshop will address the Transparency aspects of the new Clinical Trials Regulation expected to become applicable in 2016, the EMA clinical data transparency policy expected to be published in its final version for implementation later in 2014, and implementation of the clinical trials results submission to EudraCT for public disclosure via the EU Clinical Trials Register. The EU results requirements via EudraCT is to come in force by the finalisation of the next version update of EudraCT, expected mid 2014. The workshop will also address how these initiatives relate to the EFPIA-PhRMA “Principles for Responsible Data Sharing” and how industry is implementing the Principles.

 

Upgrade to the full three days! Add the extra day (23.9.) of the adjacent “Clinical Trials Workshop I - Translating the New Clinical Trials Regulation into Practice” for a special fee (Industry €550.00 / Government/Academia € 275.00). Online registration available for upgrade. Discount will show in the total fee on check-out.

 

An adjacent 2-day workshop on the new Clinical Trials Regulation, will offer an opportunity for attendees to focus on conceptual and practical aspects of implementation of the new Regulation. Attendees can participate in either one workshop or in the entire 3-day program. The two workshops will overlap with a day addressing the Transparency aspects of the Clinical Trials Regulation. 

Featured Topics 

  • Key aspects of the present and new requirements on clinical trials with respect to disclosure and transparency of clinical trial information
  • Impact on preparation and update of CTA submissions by sponsors
  • Preparing redacted Clinical Study Reports (CSRs) and lay summaries in response to the EFPIA-PhRMA Principles, the new EMA policy, and the new Clinical Trials Regulation
  • Role of European Commission and EMA and implementing measures
  • Entering study results into the EudraCT database versus ClinicalTrials.gov
  • Public information in the EU Clinical Trials Register from the EudraCT database
  • Industry scheme for clinical trial data sharing

Who Should Attend 

This workshop is aimed at intermediate and experienced professionals from:

  • Regulatory agencies
  • The pharmaceutical industry and Contract Research Organisations including
    • Staff from clinical data disclosure, clinical science, and clinical operations
    • Regulatory affairs personnel
    • Pharmacovigilance staff
    • Staff from Legal, Patent departments and Scientific Intelligence
  • Academic institutions
  • Physicians
  • Patient organisations

Learning Objectives 

  • Understanding the new requirements and the way they are being implemented by authorities and clinical trial sponsors including their practical and operational impact
  • Discuss and identify the key challenges and opportunities of the new requirements and policies
  • Recognise how companies and research institutions are fine-tuning and optimising processes to meet the requirements for disclosure of clinical trial information and data sharing initiatives
  • Exchange views between regulators, industry, patients, academia and other stakeholders

Hotel & Travel 

Millennium Gloucester Hotel London Kensington
A limited number of rooms are available at a special rate. DIA rate is guaranteed until 11 August 2014, or until room block is filled. Attendees should make reservations as soon as possible.

To make your booking, go to www.millenniumhotels.co.uk/millenniumgloucester/
Booking Code: LOND230914 (insert the code into the CORP/PROMO CODE box)
Single GBP 140.00/Double GBP 150.00 including breakfast and VAT

Address: 4-18 Harrington Gardens, London SW7 4LH, UK
Tel:  +44(0) 207 331 6105 Fax: +44(0) 207 331 6123

Travel Information
For details on public transport please visit http://www.tfl.gov.uk

Contact Information 

Registration Questions
Phone.: +41 61 225 51 51
Fax: +41 61 225 51 52
Monday-Friday 8:00-17:00 CET
diaeurope@diaeurope.org

Agenda and Event Logistics
Nicole Hintersatz, Event Manager
Phone: +41 61 225 51 60
Fax: +41 61 225 51 52
nicole.hintersatz@diaeurope.org

 

 

Program Committee 

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Agenda  

Day 1 Wednesday, Sep 24, 2014

  • 9:00AM - 10:30AM (Central European Standard Time)

    WED Session 1: PROVISIONS UNDER THE NEW REGULATION – REQUIREMENTS FOR THE DATABASE AND TRANSPARENCY


    Session Chair(s):

    • Fergus Sweeney, PhD
      Head of Inspections and Human Medicines Pharmacovigilance (Division)
      European Medicines Agency, European Union, United Kingdom

    Speaker(s):

    • The new EU Portal and Database – What to be expected by when?
      Ana Rodriguez, PhD
      Head of Clinical and Non-Clinical Compliance
      European Medicines Agency, European Union, United Kingdom
    • Expectations by Member States for Competent Authorities and Ethics Committees
      Stefan Strasser, MD
      Clinical Assessor
      AGES/BASG, Austria
    • Learning From Experience – Industry’s hopes and concerns?
      Angelika Joos, MPharm
      Executive Director, Global Regulatory Policy
      MSD (Europe) Inc., Belgium
  • 10:30AM - 11:00AM (Central European Standard Time)

    COFFEE BREAK
  • 11:00AM - 12:30PM (Central European Standard Time)

    WED Session 2: CLINICAL TRIAL DATA TRANSPARENCY AND MAAS– HOW TO MOVE TO THE FUTURE?


    Session Chair(s):

    • Noël Wathion, RPh
      Chief Policy Adviser
      European Medicines Agency, European Union, United Kingdom

    Speaker(s):

    • EMA’s vision for Availability of Clinical Trial Information from Marketing Authorisation Applications and How it is to be Achieved
      Noël Wathion, RPh
      Chief Policy Adviser
      European Medicines Agency, European Union, United Kingdom
    • What changes will new transparency provisions bring for researchers?
      Catrin Tudur Smith
      Reader in Medical Statistics
      Liverpool University, United Kingdom
    • What does greater availability of clinical trial information mean for HTA?
      Meindert Boysen
      Programme Director Technology Appraisals, PASLU and HST
      National Institute for Health and Care Excellence, United Kingdom
  • 12:30PM - 2:00PM (Central European Standard Time)

    LUNCH
  • 2:00PM - 3:00PM (Central European Standard Time)

    WED Session 3: EXPECTATIONS – WHAT STAKEHOLDERS EXPECT FROM THE NEW TRANSPARENCY REQUIREMENTS


    Session Chair(s):

    • Ingrid Klingmann
      European Forum for Good Clinical Practice (EFGCP), Belgium

    Speaker(s):

    • Patient Organisation Representative
      Kaisa Immonen-Charalambous
      Senior Policy Adviser
      European Patients' Forum, Belgium
    • Ethics Committee Representative
      Joerg Hasford
      Ludwig-Maximilians Univ, Germany
  • 3:00PM - 3:30PM (Central European Standard Time)

    COFFEE BREAK
  • 3:30PM - 5:00PM (Central European Standard Time)

    WED Session 4: INDUSTRY COMMITMENT – FROM DATA SHARING POLICY TO IMPLEMENTATION


    Session Chair(s):

    • No-image Hanns-Georg Leimer, PhD
      Head of Transparency, Disclosure, and Application Governance within Medical
      Boehringer Ingelheim Pharma , Germany

    Speaker(s):

    • How does the new policy translate for the industry? A company approach
      Robert Frost
      Policy Director
      GlaxoSmithKline, United Kingdom
    • Commercially Confidential Information – Where to draw the line?
      Victoria Kitcatt, LLM
      Vice President and Assistant General Counsel, European Regulatory Law
      Pfizer Limited, United Kingdom
    • How may data transparency contribute to improving the development of medicines?
      Rebecca Sudlow, MS
      Statistics Team Leader
      Roche Products ltd, United Kingdom

Day 2 Thursday, Sep 25, 2014

  • 9:00AM - 10:30AM (Central European Standard Time)

    THU Session 1: OPERATIONAL ASPECTS OF DATA SHARING: CLINICAL STUDY RESULTS AND PATIENT LEVEL DATA


    Session Chair(s):

    • No-image Holger Maria Rohde, PhD
      Merck KGaA, Germany

    Speaker(s):

    • Independent Review Panel – different models
      Nicola Perrin
      Head of Policy
      Welcome Trust, United Kingdom
    • Perspectives from Academia
      Catrin Tudur Smith
      Reader in Medical Statistics
      Liverpool University, United Kingdom
    • How can patient confidentiality be maintained?
      Robert Frost
      Policy Director
      GlaxoSmithKline, United Kingdom
  • 10:30AM - 11:00AM (Central European Standard Time)

    COFFEE BREAK
  • 11:00AM - 12:30PM (Central European Standard Time)

    Session 2: A PERSPECTIVE OUT OF EUROPE – REGIONAL AND LOCAL REGISTRIES - CONSIDERATIONS OF TRANSPARENCY


    Session Chair(s):

    • No-image Robert Paarlberg, MS
      Principal
      Paarlberg & Associates LLC, United States

    Session 2: A PERSPECTIVE OUT OF EUROPE – REGIONAL AND LOCAL REGISTRIES - CONSIDERATIONS OF TRANSPARENCY

    Speaker(s):

    • Overview of Regional/Country Registries and Results Disclosure
      John C. McKenney
      President
      SEC Associates, Inc., United States
    • Regulatory and Policy Issues in the USA
      Rebecca J. Williams, PharmD, MPH
      Assistant Director, ClinicalTrials.gov
      National Library of Medicine, NIH, United States
    • EU-CTR and National Registers - way into the future?
      Thorsten Ruppert
      Senior Manager Research/Development/Innovation
      vfa - German Association of Research-Based Pharmaceutical Companies, Germany
  • 12:30PM - 2:00PM (Central European Standard Time)

    LUNCH
  • 2:00PM - 3:30PM (Central European Standard Time)

    US Requirements on Results Reporting – and international context


    Session Chair(s):

    • No-image Merete Joergensen, MBA, MSc
      Director, Global Clinical Registry
      Novo Nordisk A/S, Denmark

    US Requirements on Results Reporting – and international context

    Speaker(s):

    • How to cope with the posting back to 2004?
      Azin Shahzamani
      Senior Director, Regulatory Affairs
      Genentech, A Member of the Roche Group, United States
    • EMA – Practical considerations of EudraCT and EU CTR postings, and international context
      Noemi Manent
      Scientific Administrator, Compliance and Inspection
      European Medicines Agency, United Kingdom
    • US Requirements on Results Reporting – and international context
      Rebecca J. Williams, PharmD, MPH
      Assistant Director, ClinicalTrials.gov
      National Library of Medicine, NIH, United States

Registration Fees 

Member

Member Academia
€710.00
Member Government
€710.00
Member Standard
€1420.00

Non-Member

NonMember Academia
€840.00
NonMember Government
€840.00
NonMember Standard
€1550.00
Group Discounts

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

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

Upgrade available: Add a day (23.9.) of the adjacent #14111 “Clinical Trials Workshop I - Translating the New Clinical Trials Regulation into Practice” for a special fee: Industry €550.00 / Government/academia € 275.00. Online registration available for upgrade, discount will show on check-out.

Register Online
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