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DAY THREE - EST (Eastern Standard Time, GMT-5)

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DAY THREE - EST (Eastern Standard Time, GMT-5)

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8:00am - 8:20am20 mins
PLAIN LANGUAGE SUMMARIES OF CLINICAL TRIAL RESULTS
EU Clinical Trial Regulation: New Commission Recommendations on Good Lay Summary Practice (GLSP)
  • Ingrid Klingmann - Chairman, European Forum for Good Clinical Practice (EFGCP), Belgium
8:20am - 8:40am20 mins
PLAIN LANGUAGE SUMMARIES OF CLINICAL TRIAL RESULTS
Expanding the Foundations of the Good Lay Summary Practice (GLSP) Guidance: Hot Topics
  • Thomas Schindler - Innovation Medical Writing, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
8:40am - 9:00am20 mins
PLAIN LANGUAGE SUMMARIES OF CLINICAL TRIAL RESULTS
Considerations for Presentation of Secondary Endpoints in Plain Language Clinical Trial Result Summaries: Multi-stakeholder Perspectives for Emerging Practice
  • Caragh Murray - Plain Language Summary Program Manager, The Janssen Pharmaceutical Companies of Johnson & Johnson, USA
9:00am - 9:20am20 mins
PLAIN LANGUAGE SUMMARIES OF CLINICAL TRIAL RESULTS
Plain Language Clinical Research Glossary
  • Sylvia Baedorf Kassis - Program Manager, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard, USA
9:20am - 9:40am20 mins
PLAIN LANGUAGE SUMMARIES OF CLINICAL TRIAL RESULTS
Plain Language Summaries for Pediatrics
  • Theresa Shalaby - Senior Regulatory Services Manager, Synchrogenix, a Certara company, USA
9:40am - 10:20am40 mins
LIVE Virtual Hub Networking
    10:20am - 11:00am40 mins
    PLAIN LANGUAGE SUMMARIES OF CLINICAL TRIAL RESULTS
    PANEL: Considerations for Presentation of Secondary Endpoints in Plain Language Clinical Trial Result Summaries
    • Debra Guerreiro - Plain Language Summary Program Lead, Data Transparency, Integrated Data Analytics and Reporting (IDAR), Global Development, Janssen R&D, USA
    • Maureen Mooney Kashuba - Plain Language Summary Project Lead, Merck & Co., Inc, USA.
    • Caragh Murray - Plain Language Summary Program Manager, The Janssen Pharmaceutical Companies of Johnson & Johnson, USA
    • Jessica Valencia - Operational Excellence Expert, Novartis, USA
    • Thomas Schindler - Innovation Medical Writing, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
    • Deborah Collyar - President, Patient Advocates In Research (PAIR), USA
    11:00am - 11:20am20 mins
    PLAIN LANGUAGE SUMMARIES OF CLINICAL TRIAL RESULTS
    CASE STUDY: Plain Language Summaries for Early Phase Trials at Novartis
    • Jessica Valencia - Operational Excellence Expert, Novartis, USA
    11:20am - 11:40am20 mins
    PLAIN LANGUAGE SUMMARIES OF CLINICAL TRIAL RESULTS
    Lessons learnt from PLS implementation
    • Vidhi Vashisht - Associate Director, Kinapse, India
    11:40am - 12:00pm20 mins
    PLAIN LANGUAGE SUMMARIES OF PUBLICATIONS
    Disclosure of Clinical Trial Data Through Scientific Publications
    • Sonia A. Schweers - Publication Compliance Lead, WW Medical Compliance & Governance, Medical Capabilities, Bristol Myers Squibb, USA
    12:00pm - 12:40pm40 mins
    LIVE Virtual Hub Networking
      12:40pm - 1:00pm20 mins
      PLAIN LANGUAGE SUMMARIES OF PUBLICATIONS
      Update on the PLSP- Plain Language Summaries Publication - What are PFMD doing with the guidance doc?
      • Anne-Marie Hamoir - Senior Consultant, Patient Focused Medicines Development (PFMD), the Synergist, Brussels
      • Thomas Schindler - Innovation Medical Writing, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
      1:00pm - 1:20pm20 mins
      PLAIN LANGUAGE SUMMARIES OF PUBLICATIONS
      Plain Language Summaries and how they Evolved from Original need to know and how they can Revolutionize Scientific Disclosures
      • Iwona Bucior - Sr. Director, Medical Affairs, Bristol Myers Squibb, USA
      1:20pm - 2:00pm40 mins
      PLAIN LANGUAGE SUMMARIES OF PUBLICATIONS
      PANEL: Where we are and where we are going with - PLSP Publications
      • Thomas Schindler - Innovation Medical Writing, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
      • Anne-Marie Hamoir - Senior Consultant, Patient Focused Medicines Development (PFMD), the Synergist, Brussels
      2:00pm - 2:05pm5 mins
      End of the Conference
        DAY TWO
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