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Wednesday, June 19 • 9:15am - 9:45am
#314 IT: IQVIA Innovation Theater: Pre-Approval Access - Strategies for Providing Investigational Product to Patients Beyond Clinical Trials

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Component Type: Session

This session on Pre-Approval Access (PAA) will address key considerations and challenges for provision of investigational products to patients outside of clinical trials, and before these therapies are approved by regulators. We will focus on key decisions and success factors for organizations to consider when developing their company’s philosophy on this type of access. We will also highlight pragmatic decisions that play into the development of efficient Pre-Approval Access programs.

Chair

IQVIA

Speaker

Speaker
Barbara Isquith Arone, MS

Speaker
Ana Tediosi


Speakers
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IQVIA

United States
avatar for Barbara Isquith Arone

Barbara Isquith Arone

Vice President, Evidence Generation for Medical Affairs, IQVIA, United States
Barbara has worked within late phase research for 20+ years, 18 with IQVIA. She is responsible for the development and support of market facing and operational aspects of the following study types: disease and product registries, natural history studies, low interventional and pragmatic... Read More →
avatar for Ana Tediosi

Ana Tediosi

Head of Expanded Access Strategy, WEP Clinical, United Kingdom
With over 10 years of experience in the pharmaceutical industry, Ana is a recognized expert in the field of Expanded Access Programs (EAP). Her expertise lies in oncology, hematology, Rare Diseases, and she has held various roles in the big Pharma (BMS, Roche, Menarini-Stemline... Read More →

Wednesday June 19, 2024 9:15am - 9:45am PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session