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Monday, June 20 • 4:00pm - 5:00pm
#133: New Tools for Creating Flexible and Sustainable Master Protocols

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-526-L04-P ; CME 1.00; RN 1.00

Master protocols enable innovative complex trials but can be highly detailed and challenging to review, which can impede their successful implementation. The TransCelerate Common Protocol Template can be a framework for developing master protocols.

Learning Objectives

Identify key considerations for preparing master protocols; Apply the Common Protocol Template to master protocols; Recognize opportunities to utilize the IMI EU-PEARL integrated research platform framework, including a master protocol template, to set up a platform trial.

Chair

Nancy Tam, MS

Speaker

Industry Update
Madhavi Gidh-Jain, PhD

Industry Update
Mary Lynn Mercado, PhD



Speakers
avatar for Nancy Tam

Nancy Tam

Head of Medical Writing, Pfizer Inc, United States
Nancy Tam is the Head of Medical Writing at Pfizer and has more than 20 years of experience as a medical writing professional in the biopharmaceutical industry. Nancy has a longstanding interest in clinical trial design and serves as a business process owner for the interventional... Read More →
avatar for Madhavi Gidh-Jain

Madhavi Gidh-Jain

Medical Writing Head, Sanofi, United States
Madhavi Gidh-Jain has more than 20 years of experience in designing, writing, and reviewing medical and regulatory documents for pharmaceuticals, biologics, devices, and combination healthcare products. Currently, Madhavi is the Head of Medical Writing for multiple therapeutic areas... Read More →
avatar for Mary Lynn Mercado

Mary Lynn Mercado

Senior Group Head Regulatory Writing, Novartis Pharmaceuticals Corporation, United States
Mary Lynn Mercado is a US Group Head of Regulatory Medical Writing, Pharma at Novartis Pharmaceuticals Corporation. She has over 10 years of experience in the biopharmaceutical industry in Medical Writing, during which she has supported submissions across multiple therapeutic areas... Read More →


Monday June 20, 2022 4:00pm - 5:00pm CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Session |   04: MedAffairs-SciComm, Session