Web Code: ComboP7-11
Member/Nonmember Price: $75
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.
Department Operations | Regulatory Affairs | Clinical Affairs | Manufacturing | Quality| Product and Process Development Engineering | Project Management
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
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, FDAMichael Wiklund, Founder, Wiklund Research and Design, Inc.
Jason E. Brown
Senior Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093