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 8C: Risk Management for Biologicals

Session Chair(s)

Peter  Richardson, PhD

Peter Richardson, PhD

Head of Quality, Specialised Scientific Disciplines Department

European Medicines Agency, Netherlands

This session will look at some of the issues arising in managing risks for large (biological) molecules, mainly from the perspective of QbD. ICH guidelines detail approaches to risk management, however interpretation of these concepts have not always been consistently applied to the development of control strategies for biological substances. Of particular importance is providing assurance that Critical Quality Attributes have been appropriately identified and placed in the control strategy. Risk ranking and filtering is an important tool for this purpose, yet other tools can be employed to achieve this. Speakers with industry and regulatory experience will share their perspectives on how this may be applied for innovator and biosimilar products.

Speaker(s)

Patrick G. Swann, PhD, MS

Fit For Purpose Quality Attribute Risk Assessments

Patrick G. Swann, PhD, MS

United States

Kowid  Ho, PharmD

Risk Management Applied to Control Strategy

Kowid Ho, PharmD

F. Hoffmann-La Roche Ltd, Switzerland

Pharma Technical Regulatory Policy

Martin  Schiestl, PhD

Quality Risk Management in the Biosimilar Development

Martin Schiestl, PhD

Sandoz GmbH, Austria

Global Head Regulatory Affairs Policy

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.