marcus evans europe conferences

TMF and Clinical Operations Quality Excellence

Getting The Best Framework For Integrating Quality Processes Into Clinical Documentation, Enhance Data Integrity And Risk Based Management Tools To Meet Inspection Readiness And Assure Vendor Quality Oversight

19-21 March 2018
Mövenpick Hotel, Berlin, Germany

Why You Should Attend

TMF and Clinical Operations Quality Excellence

How to think the TMF operations within a broader quality system, assuring that completeness, compliance, integrity of data can be supported thanks to qualified organizational processes aligned with GCP expectations?

The new marcus evans conference “TMF Operations: a Quality and Regulatory Approach” will help clinical operations and documentation professionals to develop better practice and methods to improve safety and performance in clinical trials system while supporting more efficient inspection readiness. With various case studies and discussions platform, this conference will give the opportunity for attendees to boost their practical knowledge and professional experience on quality requirements within trial master plans using a risk based approach and CAPA methods, understanding the new GCP E6 (R2) requirements, discussing continual improvement, featuring electronic transfer, addressing the challenge of fragmented operations and systems with standardized processes. Let’s open the silos and learn from cross functional approach! 

Key Topics

  • Integrate a quality approach into clinical operation routine
  • Align processes and requirements within multiple stakeholders and systems
  • Approach documentation, archive and records in a more efficient way
  • Control the completeness of your TMF with a robust plan
  • Learn practical experience on quality vendor oversight
  • Previous Attendees Include

    Eli Lilly
    Boehringer Ingelheim
    Johnson & Johnson
    Bristol-Myers Squibb
    Daiichi Sankyo
    Biogen Idec
    Janssen Pharmaceutical
    Shire Pharmaceutical

    Why Choose marcus evans?

    marcus evans specialises in the research and development of strategic events for senior business executives. From our international network of 63 offices, marcus evans produces over 1000 event days a year on strategic issues in corporate finance, telecommunications, technology, health, transportation, capital markets, human resources and business improvement.

    Above all, marcus evans provides clients with business information and knowledge which enables them to sustain a valuable competitive advantage and makes a positive contribution to their success.

    Event Sponsors
    Visit website >>

    Event Partners

    Practical Insights From

    Franck Gressier
    Head Clinical Quality Assurance
    Pierre Fabre

    Klaus Finneiser
    P3 Quality consultant & Risk management
    Former Head Quality Systemand Strategy at Acino Pharma

    Thomas Scholze
    Assoc. Director Clinical Quality group

    Marion Tonsch
    Global Document Specialist & Global Document Quality Centre
    Boehringer Ingelheim

    Eldin Rammell
    Managing Director
    Rammell Consulting

    Marion Pillwein
    R&D Quality Risk Management Lead Biopharma | Global Research & Development Quality (RDQ)

    Heiner Gertzen
    Head GxP Inspection & Audit Readiness

    Gergana Koutsarova
    Global TMF Process Owner

    Click Here For Full Agenda

    Voice of Our Customers
    • “The conference is well organised and speakers are all high quality!” Programme Coordinator J&J
    • “High quality speakers, enjoyed the networking” VP Debiopharm
    • “I appreciated the conference a lot, having the possibility to compare project management actions of my company with the other companies” Project Manager R&D Chiesi
    Latest Conference News & Resources

    Join the Discussion

    Follow on LinkedIn

    Event Contact

    For all enquiries regarding speaking, sponsoring and attending this conference contact:

    Melini Hadjitheori

    PO Box 24797
    CY-1304 Nicosia

    +357 22 849 308
    Fax: +357 22 849 394