2011 Combination Products Workshop – P6 – Post Market Consideration

Web Code: ComboP6-11
Member/Nonmember Price: $75

Seminar Summary

This seminar will consider the role of post-marketing safety surveillance and other design corrective and preventive action inputs in product design evolution and validation during the life-cycle of a device containing combination product.

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

Presenters Bio

Suzanne Kiani, Associate Director, Regulatory Affairs, CMC, MedImmune, Inc.

Mrs. Kiani is responsible for leading regulatory strategy development and implementation for biotechnology based programs as well as the Regulatory subject matter expert for delivery device and combination product strategies. She has over 12 years of experience in the field of combination products, including pulmonary delivery devices, orthopedic implants, hemostatic products and drug-eluting stents. For the past 6 years she has focused on injectable delivery of therapeutic proteins and monoclonal antibodies, alternative formulation strategies for parenteral products and companion diagnostics; previously at Genentech, and now at MedImmune. Mrs. Kiani is an expert on ISO/TC 84 and 76 and is a member of the Combination Product Coalition, PDA Combination Product Task Force, AAPS and AdvaMed. Mrs. Kiani received a B.A. in Chemistry from Scripps College and a M.S. in Drug Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy.

Matthew Kanter, Director, Quality, Zogenix, Inc.

Matthew Kanter, Director of Quality for Zogenix, has been in Quality, Compliance and Regulatory Affairs for over 20 years, has held leadership positions implementing and managing quality systems for startup and established biotech, pharma, and medical product companies. With a degree from the University of Michigan focused on biology/biochemistry, he specializes in handling and preparing firms for regulatory inspections, bringing R&D processes to commercial and regulatory standards, and leading teams and contractors to implementing and validating complex processes and technologies.

Registration contact

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