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Monday, June 27 • 8:30am - 9:45am
#115: Clinically Relevant Specifications: Translating Voice of the Patient Into Quality Attributes of the Product

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-605-L04-P; CME 1.25; IACET 1.25; RN 1.25

Clinical relevance has re-emerged within recent discussions in both the quality and regulatory arenas, with specific focus on patient expectations, clinically relevant specifications, residual uncertainty, and benefit-risk based decision making. Translating highly technical information into the pertinent patient-centric frame requires an intricate balance. This session highlights multiple opportunities for collaboration and communication, with the end goal of improving medicines, ensuring their availability, and assuring their use in accordance with patient needs.

Learning Objectives

Share common experiences regarding the establishment of clinically relevant specifications; Identify areas for future discussion with regard to clinical relevance in the quality arena; Discuss specific cases that illustrate establishment and/or challenges establishing clinically relevant specifications.


Richard T. Lostritto


Paving the Road Toward Setting Clinically Relevant Drug Product Specifications: The Relevance of Biopredictive Dissolution Testing
Sandra Suarez Sharp, PhD

Industry Perspective
Ganapathy Mohan, PhD

FDA Perspective
Laurie Graham


Richard Lostritto

Acting Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA
Richard (Rik) Lostritto currently serves as a Division Director In FDA's ONDQA. Prior to this, he served in the FDA as a Team Leader, and Chemsitry Reviewer.


Laurie Graham

Director, DIPAP, OPPQ, OPQ, CDER, FDA, United States
Laurie Graham is currently the Director of the Division of Internal Policies and Programs (DIPAP) in the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) at the Center for Drugs Evaluation and Research (CDER). DIPAP is responsible for... Read More →
avatar for Ganapathy Mohan

Ganapathy Mohan

Head of External Affairs (Quality), Merck & Co., Inc., United States
Ganapathy Mohan leads the Global External Advocacy and strategies for Global Quality and Compliance. Prior to this until April 2017, he was the head of Small Molecule Development Quality. Mohan was the head of Global CMC regulatory Affairs at Merck until April 2015. Prior to joining... Read More →

Sandra Suarez Sharp

Biopharmaceutics Lead (Acting), DB Branch III, ODNP, OPQ, CDER, FDA
Dr. Sandra Suarez-Sharp joined the Office of Clinical Pharmacology (OCP) at the FDA, in September 1999. Currently, she works at the Office of New Drug Products/Division of Biopharmaceutics (FDA/OPQ/ONDP) as a Master Biopharmaceutics Reviewer/Biopharmaceutics Lead (acting) supporting... Read More →

Monday June 27, 2016 8:30am - 9:45am EDT
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 12: Pharm Quality, Session