Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Hyatt Regency Bethesda

Apr 13, 2015 7:00 AM - Apr 15, 2015 12:00 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

CMC Workshop 2015

Session 1: Life Cycle Management

Session Chair(s)

Jean-Louis  Robert, PhD

Jean-Louis Robert, PhD

Former CHMP/CVMP QWP Chair

Luxembourg

Moheb M. Nasr, PhD, MS

Moheb M. Nasr, PhD, MS

Principal

Nasr Pharma Regulatory Consulting, United States

The concepts described in ICH Q8, Q9, Q10 and Q11 provide opportunities for a more science- and risk-based approach for developing medicinal products. However full implementation of these concepts have not been realized mainly with regards to assessing changes across the life cycle of pharmaceutical products. Several gaps exist which limit intended benefits: criteria for a harmonized risk-based change management system that effectively evaluates the impact of change on quality, clarity of the expectations of a knowledge management system that ensures continuity of product and process information, and appropriate level of detail and information sufficient for regulatory assessment and inspection.

Leading regulators, from Europe and the United States, will join industry speakers to share their perspectives on this topic and provide an update on progress made to date. Presentations will be followed by panel discussions.

Speaker(s)

Moheb M. Nasr, PhD, MS

Life Cycle Management - ICH Q12

Moheb M. Nasr, PhD, MS

Nasr Pharma Regulatory Consulting, United States

Principal

Ganapathy  Mohan, PhD

Life Cycle Management - Industry Perspective and Case Studies

Ganapathy Mohan, PhD

Merck & Co., Inc., United States

Head of External Affairs (Quality)

Jean-Louis  Robert, PhD

Life Cycle Management - EU Perspective

Jean-Louis Robert, PhD

Luxembourg

Former CHMP/CVMP QWP Chair

Robert  Iser, MS

Life Cycle Management - FDA Perspective

Robert Iser, MS

Genentech, A Member of the Roche Group, United States

Lead, Quality Policy and Advocacy, Pharma Technical Quality and Compliance

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.