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Tuesday, June 18 • 1:15pm - 2:15pm
#245: The European Clinical Trials Environment Under the Accelerating Clinical Trials (ACT EU) Initiative: Two Years On

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-583-L04-P; CME 1.00; RN 1.00

Accelerating Clinical Trials in the EU (ACT EU) and the successful launch of the clinical trial regulation have modernized the clinical trial environment. This session is focused on how Europe is embracing the change and will also present other international initiatives offering opportunities for collaboration.

Learning Objectives

Describe how ACT EU, together with other EU initiatives, is providing a platform to optimize clinical research and development, and fostering innovation through joint collaborations between member states, ethics committees, and stakeholders, bringing tangible benefits for patients, sponsors, and regulators; Discuss other international clinical trial initiatives and potential areas of collaboration.

Chair

Ana Zanoletty Perez

Speaker

FDA Update
Shari Targum, MD, MPH, FACC, FACP

Academic Update
Sara Bristol Calvert, PharmD

Patient Advocate Perspective
Deborah Collyar

WHO Update
Marion Laumonier, MSc


Speakers
avatar for Sara Calvert

Sara Calvert

Director of Projects, Clinical Trials Transformation Initiative (CTTI), United States
Dr. Sara Bristol Calvert is currently the Director of Projects at the Clinical Trials Transformation Initiative (CTTI). Prior to this role, she was a CTTI Senior Project Manager which included leading projects in Diversity in Clinical Trials, Single IRB, Registry Trials, HABP/VABP... Read More →
avatar for Deborah Collyar

Deborah Collyar

President, Patient Advocates In Research (PAIR), United States
Deborah Collyar is founder and president of Patient Advocates in Research (PAIR), “where research meets reality.” Her leadership in patient engagement and advocacy started in the 1990s after her first cancer diagnosis. She applies business leadership, IT, communication and strategic... Read More →
avatar for Marion Laumonier

Marion Laumonier

Technical Officer, Regulatory Convergence and Networks, World Health Organization (WHO), Switzerland
Marion Laumonier is currently Technical Officer in the Regulatory Convergence and Networks team at the WHO in Geneva, Switzerland. Marion Laumonier joined the WHO in 2021 and has over 20 years of experience gained in different settings, pharmaceutical industries and non-profit organizations... Read More →
avatar for Ana Zanoletty Perez

Ana Zanoletty Perez

Head of Clinical Trials Transformation workstream, European Medicines Agency, Netherlands
Ana qualified as a pharmacist and following various roles managing clinical trials for the biopharmaceutical industry joined EMA in 2006. At EMA she spent her initial years coordinating initial marketing authorisation procedures, and later transitioned into the management of post-authorisation... Read More →
ST

Shari Targum

Deputy Director, Office of Clinical Policy, OC, FDA, United States
Dr. Shari Targum has over 30 years of clinical, industry and regulatory experience. She began her FDA career in 1999 as a Medical Officer and then Team Leader in CDER's Division of Cardiovascular and Renal Products and she has held positions of increasing authority in CDER and CBER... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session |   02: ClinTrials -ClinOps, Session