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Clinical Trials Workshop I - Translating the New Clinical Trials Regulation into Practice

Sep 23 2014 9:00AM - Sep 24 2014 5:00PM | Millennium Gloucester Hotel London Kensington 4-18 Harrington Gardens London SW7 4LH United Kingdom

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The new EU Clinical Trials Regulation is expected to become applicable in 2016. The new legislation will have implications on clinical trial sponsors preparing and submitting clinical trial applications. Member States will have to adapt their procedures for the assessment of clinical trial applications by competent authorities and review by ethics committees. Additionally, the new Regulation will impact how the conduct of a clinical trial is managed after approval has been granted. New provisions for public access to an EU clinical trials database will enforce disclosure of clinical trials data and information.

This 2-day workshop will provide a forum for information exchange and discussion on conceptual and practical questions through lectures, panel discussions, and interactive break-out sessions. Day 1 will focus on the new provisions for submission, assessment and decision-making of clinical trial applications, and the management and monitoring of trials. Day 2 will focus on the new transparency provisions for clinical trials.


Upgrade to the full three days! Add the extra day (25.9.) of the adjacent “Clinical Trials Workshop II - Translating the New Transparency Requirements 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 clinical data transparency, will focus on practical considerations for the disclosure of clinical trials data. 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.

There will be an introductory session at the beginning of the workshop for those attendees, who feel they need an overview on the new legislation to enable them to participate in discussions throughout the event.


Featured Topics 

  • Key aspects of the new requirements on managing clinical trials including:
    • Coordinated assessment by Member States
    • Cooperation between Agencies and Ethics Committees
    • Clinical trial application dossier requirements
    • Reporting of safety information
    • Impact of requirements for disclosing data from clinical trials and how they work alongside other clinical trial data disclosure initiatives
  • Plans for implementation in the Member States
  • Exchange of views between regulators, industry, patients, academia and other stakeholders

Who Should Attend 

This workshop is aimed at intermediate and experienced professionals from:

  • Regulatory agencies
  • The pharmaceutical industry and Contract Research Organisations including:
    • Clinical science and clinical operations
    • Monitors, auditors of clinical trials
    • Regulatory affairs
  • Pharmacovigilance
  • Academic institutions
  • Physicians
  • Patient organisations

Learning Objectives 

  • Understanding the new requirements and the way implementation is being considered 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 of the clinical trials Regulation
  • 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

Agenda and Event Logistics
Kaija Kurki-Suonio, Event Manager
Phone: +41 61 225 51 63
Fax: +41 61 225 51 52



Program Committee 

Previous Next


Day 1 Tuesday, Sep 23, 2014

  • 9:30AM - 10:00AM

  • 10:00AM - 11:00AM


    Session Chair(s):

    • Nick Sykes, MS
      Senior Director, Worldwide Safety & Regulatory
      Pfizer Inc., United Kingdom


    • Sabine Atzor, RPh
      Head of EU Regulatory Policies
      F. Hoffmann-La Roche Ltd., Switzerland
    • Representative Invited
      Clinical Assessor
    • Susan Forda, PhD, MBA
      Vice President, International Regulatory Affairs
      Eli Lilly & Company Ltd., United Kingdom
  • 11:00AM - 12:15PM

    TUE Session 2: Submission, Assessment, Decision of a Clinical Trial Application – A new paradigm – Perspective from the Member States

    Session Chair(s):

    • Representative Invited
      Expert Inspector, GCP


    • From Voluntary Harmonisation Procedure to Clinical Trials Regulation: How long is the way to go?
      Hartmut - Krafft, PhD, MSc
      Head, Clinical Trials Unit
      Paul-Ehrlich-Institut, Germany
    • Challenges Faced by MS for Implementation
      Stefan Strasser, MD
      Clinical Assessor
      AGES/BASG, Austria
    • Integration of Ethics Committees into the Process – A Model Example
      Joerg Hasford
      Ludwig-Maximilians Univ, Germany
  • 12:15PM - 1:30PM

  • 1:30PM - 3:00PM

    TUE Session 3: Submission, Assessment, Decision of a Clinical Trial Application – A new Paradigm – Perspective from Commercial Sponsors

    Session Chair(s):

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


    • The New Process – Where are the open question marks?
      Judith Creba, PhD
      Head EU Liaison and Policy
      Novartis Pharma AG, Switzerland
    • How do companies need to get ready for the new regulation?
      Mark Andrew Rutter
      Associate Director, Regulatory Policy & Intelligence
      Abbvie Ltd, United Kingdom
  • 2:30PM - 3:00PM

    Panel discussion with speakers from Sessions 1 - 3

    Session Chair(s):

    • Ingrid Klingmann
      European Forum for Good Clinical Practice (EFGCP), Belgium
  • 3:00PM - 3:30PM

  • 3:30PM - 3:30PM

    TUE Session 4: Protection of the Subject

    Session Chair(s):

    • Esteban Herrero-Martinez, PhD
      Director, Regulatory Intelligence
      Daiichi Sankyo Development Ltd., United Kingdom


    • Informed Consent – What matters to patients?
      Kaisa Immonen-Charalambous
      Senior Policy Adviser
      European Patients' Forum, Belgium
    • Safety Reporting – How to ensure cooperation between Member States
      Elke Stahl
      Nonclinical Assessor, Clinical Trial Unit
      BfArM, Germany
  • 4:00PM - 4:45PM

    Panel discussion with Q&A
  • 4:45PM - 5:45PM

    TUE Session 5: Perspective of Other Stakeholders

    Session Chair(s):

    • Isabelle Clamou
      Regulatory affairs Director - EU Policy
      Amgen Ltd, Belgium


    • How will academia manage new processes in the future?
      Daniel Bridge
      Policy Manager
      Cancer Research UK, United Kingdom
    • Where do CROs need to re-adjust their processes?
      John Poland, PhD
      Senior Director, Regulatory Policy and Compliance
      Covance Clinical Development Services, United Kingdom

Day 2 Wednesday, Sep 24, 2014

  • 9:00AM - 10:30AM


    Session Chair(s):

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


    • 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
    • Representative Invited
      Clinical Assessor
    • Learning From Experience – Industry’s hopes and concerns?
      Angelika Joos, MPharm
      Executive Director, Global Regulatory Policy
      MSD (Europe) Inc., Belgium
  • 10:30AM - 11:00AM

  • 11:00AM - 12:30PM


    Session Chair(s):

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


    • EMA’s vision for Availability of Clinical Trial Information from Marketing Authorisation Applications and How it is to be Achieved
      Noel 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

  • 2:00PM - 3:00PM

    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


    • Representative Invited
      Health Policy Officer
    • Ethics Committee Representative
      Joerg Hasford
      Ludwig-Maximilians Univ, Germany
  • 3:00PM - 3:30PM

  • 3:30PM - 5:00PM

    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


    • 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


DIA will offer exhibition for this meeting.

Download Application Form


For more information please contact: Roxann Schumacher, DIA Exhibits Manager 

+41 61 225 51 38 or email: roxann.schumacher@diaeurope.org

Registration Fees 


Member Academia
Member Government
Member Standard
Member Standard (As of 08/13/2014)


NonMember Academia
NonMember Government
NonMember Standard
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 third day (25.9.) of the adjacent #14116 “Clinical Trials Workshop II - Translating the New Transparency Requirements 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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