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Wednesday, June 27 • 4:00pm - 5:15pm
#390: Special Population Study Challenges

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-681-L04-P; CME 1.25; IACET 1.25; RN 1.25

Early phase pharmacokinetic studies continue to be challenging. Current issues from regulatory, CRO/Sponsor, and site perspectives will be discussed and suggestions for optimizing protocols and operations will be presented.

Learning Objectives

Describe the design challenges of special population studies; Develop practical solutions to special population study obstacles.


William B. Smith, MD


Critical Challenges in Conducting PK Studies in Patients and Special Populations
Charu Gautam, MD

Special Population Studies: Thirty Years Experience Shared
Harry Alcorn, PharmD

avatar for Harry Alcorn

Harry Alcorn

Chief Scientific Officer, DaVita Clinical Research
Chief Scientific Officer for DaVita Clinical Research a CRO, located in Minneapolis Minnesota and Lakewood Colorado. He has served as PI on over 150 protocols and Sub Investigator on over 300 protocols which have included Renal (Full and Adaptive), Hepatic and Pulmonary, along with... Read More →
avatar for Charu Gautam

Charu Gautam

Senior Medical Director, IQVIA
Charu Gautam is a Physician with over 20 years experience in research and academics. Been associated with leading companies in India to lead the clinical operations and medical teams. Qualified as MBBS, MD and a board certification in Clinical Pharmacology . She is also a lead faculty... Read More →
avatar for William Smith

William Smith

CEO, Alliance for Multispecialty Research/NOCCR
William B. Smith, MD, FACC, is a Professor of Medicine at the University of Tennessee Medical Center in Knoxville, Tennessee. Dr. Smith is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care. Dr. Smith is the President of New Orleans Center for Clinical... Read More →

Wednesday June 27, 2018 4:00pm - 5:15pm EDT
Room 156ABC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  06: PreClin Dev-EarlyPhaseCR, Session