2011 Combination Products Workshop – P7-Panel Discussion

Web Code: ComboP7-11
Member/Nonmember Price: $75

Seminar Summary

This seminar is will give the audience the opportunity to ask representatives from global regulatory agencies and the pharmaceutical industry their latest perspectives regarding the challenges we face related to Combination Products including Design Controls, Human Factors, Clinical Trials, Design Verification and Validation, and Quality Systems.

Who Should Attend

Department Operations | Regulatory Affairs | Clinical Affairs | Manufacturing | Quality| Product and Process Development Engineering | Project Management

Job Function
Individuals, at all levels, working in strategic roles in quality, regulatory, clinical and manufacturing departments in drug, biologic or medical device companies engaged in the development and manufacture of combination products

Panelists

Angela Krueger, Product Jurisdiction Officer, CDRH, FDA

Lee Leichter, President, P/L Biomedical

Carlos Mena-Grillasca, Lead Interdisciplinary Scientist, CDER, FDA

Jacqueline Ryan, PhD, Medical Officer, General Hospital Devices Branch, CDRH, FDA

Michael Wiklund, Founder, Wiklund Research and Design, Inc.

Registration contact 

Jason E. Brown
Senior Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093
Email: brown@pda.org

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