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Full Schedule

Full Schedule

  • Monday, September 9, 2024
  • 7:00 AM – 7:45 AM ET
    Meet the ACCP/ISoP Special Interest Group
  • 7:00 AM – 7:45 AM ET
    STEP & ESP Gathering
  • 7:00 AM – 8:00 AM ET
    Continental Breakfast
  • 7:00 AM – 5:00 PM ET
    ACCP Registration Open
  • 7:00 AM – 7:00 PM ET
    Exhibit Hall Open
  • 8:00 AM – 9:30 AM ET
    Symposium 5: FDA Modernization Act 2.0: How do we Fully Leverage this Unique Opportunity to Transform Drug Development?

    Co-Chair & Faculty: Navin S. Goyal, PhD – Janssen Research & Development LLC

    Co-Chair & Faculty: Gwendolyn Pais, PhD – Midwestern Univ Chicago Coll of Pharmacy

    Faculty: Rodrigo Cristofoletti, PhD (he/him/his) – Univ of Florida Coll of Pharmacy

    Faculty: Daniel Levner, MS, PhD – Emulate Inc

    Faculty: Wendy Wu, PhD – US Food & Drug Administration

    Translational Clinical Pharmacology

    CE: 1.5

  • 8:00 AM – 9:30 AM ET
    Symposium 6: Increasing Diversity in Clinical Trials: What Will it Take for Us to Close the Gap?

    Co-Chair & Faculty: Shuangwu (Cheryl) Li, PhD – Takeda Pharmaceutical Co Ltd

    Co-Chair & Faculty: Anuradha Ramamoorthy, PhD – US Food & Drug Administration

    Faculty: R. Donald Harvey, PharmD (he/him/his) – Emory Univ School of Medicine

    Faculty: Gianluca Nucci, PhD (he/him/his) – Pfizer Inc

    Clinical Trial Designs

    CE: 1.5

  • 9:30 AM – 10:00 AM ET
    Coffee & Networking Break
  • 9:30 AM – 10:00 AM ET
    Industry Theater Presentation: ACCP IDE
  • 10:00 AM – 10:30 AM ET
    Meet the EICs
  • 11:30 AM – 1:30 PM ET
    Lunch Buffet
  • 11:45 AM – 1:15 PM ET
    Lunch & Awards
  • 1:30 PM – 3:00 PM ET
    Symposium 7: Operational Considerations for Early-phase Pharmacokinetic/Pharmacodynamic/Safety Studies in Pediatric Patients

    Co-Chair & Faculty: Dionna J. Green, MD

    Co-Chair & Faculty: Susan McCune, MD (she/her/hers) – PPD/Part of Thermo Fisher Scientific

    Faculty: Randi Gower, MHA – PPD/Part of Thermo Fisher Scientific

    Faculty: John Van Den Anker, MD, PhD (he/him/his) – National Inst of Health

    Specific Populations

    CE: 1.5

  • 1:30 PM – 3:00 PM ET
    Symposium 8: Harmonization of the Bioequivalence Assessments for Narrow Therapeutic Index Drugs: Delivering the Promise to Patients

    Co-Chair & Faculty: Yu Chung Tsang, PhD (he/him/his) – YCT Scientific Inc

    Co-Chair & Faculty: Lei Zhang, PhD – US Food & Drug Administration

    Faculty: Wenlei Jiang, PhD – US Food & Drug Administration

    Faculty: Paulo Paixao, PhD – Univ of Lisbon

    Faculty: Liang Zhao, PhD – US Food & Drug Administration

    Clinical Trial Designs

    CE: 1.5

  • 3:00 PM – 3:30 PM ET
    Coffee & Networking Break
  • 3:30 PM – 5:00 PM ET
    Symposium 9: Rethinking Hepatic Impairment Studies: A Patient Centric Approach

    Co-Chair & Faculty: Navin S. Goyal, PhD – Janssen Research & Development LLC

    Co-Chair & Faculty: Martina Sahre, PhD – US Food & Drug Administration

    Faculty: William B. Smith, MD – New Orleans Ctr for Clinical Research, an AMR Co

    Faculty: Xinyuan Zhang, PhD – Daiichi Sankyo Inc

    Specific Populations

    CE: 1.5

  • 3:30 PM – 5:00 PM ET
    Symposium 10: Hot Topics: Decentralized Clinical Trials & Clinical Pharmacology, a Joint ACCP-KSCPT Symposium

    Co-Chair & Faculty: Myong-Jin Kim, PharmD (she/her/hers)

    Co-Chair & Faculty: Kyung-Sang Yu, MD, PhD – Seoul Natl Univ Coll of Medicine & Hosp

    Faculty: Seol Ju Moon, MD, PhD (she/her/hers) – Jeonbuk National Univ Hosp

    Faculty: Leonard V. Sacks, MD (he/him/his) – US Food & Drug Administration

    Clinical Trial Designs

    CE: 1.5

  • 5:00 PM – 7:00 PM ET
    Evening Reception, Exhibits & Poster Session 2
  • 7:00 PM – 9:00 PM ET
    JCP & CPDD Editorial Board Dinner (Invitation Only)