2011 PDA/FDA Joint Regulatory – P5 - Center Initiatives

Web Code: PDAFDAP511
Member/Nonmember Price: $75

Seminar Summary

Hear directly from CBER, CDER, CDRH, CVM and ORA leaders with regard to their Center’s current and future initiatives.

Who Should Attend

Departments
Research & Development | Regulatory Affairs | Manufacturing | Quality Assurance/Control | Marketing | Sales

Job Functions
Supply Chain | Clinical Supply Material Preparation | Executive Management

Presenters Bio

Steve Silverman, Director, Office of Compliance, CDRH, FDA

Steve Silverman is the Director of CDRH’s Office of Compliance.  In this role, he oversees a staff of more than 170 scientific and regulatory personnel who assure compliance with the medical-device related provisions of the federal Food, Drug, and Cosmetic Act and its implementing regulations.  Mr. Silverman also represents CDRH on agency-wide globalization initiatives and leads Center-wide compliance strategic planning efforts.  He comes to this position from his role as Assistant Director of the Center for Drug Evaluation and Research’s Office of Compliance, where he helped lead a staff that applied federal laws and regulations governing the development, manufacture, labeling, and marketing of human drugs. 

Before joining the Center for Drugs, Mr. Silverman served as an Associate Chief Counsel in FDA’s Office of Chief Counsel.  Mr. Silverman’s government service includes four-plus years as a trial attorney with the U.S. Department of Justice’s Tax Division, which he joined following his tenure with the Federal Trade Commission’s Financial Practices Division.  He began his career in private practice.

Mr. Silverman received his undergraduate degree cum laude from the University of Michigan.  He attended the University of Pennsylvania law school, where he graduated cum laude and was an editor of the University of Pennsylvania Law Review.

Christopher Joneckis, Senior Advisor for CMC Issues, CBER, FDA

Christopher Joneckis serves as the Senior Advisor For Chemistry, Manufacturing and Control (CMC) Issues, at The Center for Biologics Evaluation and Research (CBER), US FDA.  In this position, he advises on a variety of CMC issues for the Center’s regulatory, review and scientific programs and activities, and is involved in the development and implementation of several programs, policies and standards for CMC issues in the Center.  He is also involved in several Agency groups drafting CMC and cGMP policy, including the Steering Committee and working groups under the CGMP for the 21st Century Initiative, and currently a member of the FDA Pharmaceutical Quality Council implementing these activities.  In addition, he is the Quality Lead for CBER in ICH activities and has represented FDA on several ICH Quality Expert Working Groups including Q6B, CTD-Quality, Q8 and currently Q10.

He earned his Ph.D. in Pharmacology from the University of North Carolina at Chapel Hill and has over 13 years of research experience on biologics including therapeutic proteins as well as small molecules in the areas of oncology, cell adhesion and vascular disease conducted in academic and government institutions.  He joined CBER, in 1994 as a reviewer in the Office of Therapeutics.  In this capacity he reviewed IND and BLA applications and participated in pre-license and biennial facility inspections for a variety of therapeutic products including cytokines, monoclonal antibodies, thrombolytics and somatic cellular products.

Bernadette Dunham, Director, CVM, FDA

Dr. Bernadette Dunham was appointed Director of the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) on January 7, 2008, by Commissioner of Food and Drugs, Andrew C. von Eschenbach, M.D.  Prior to becoming CVM’s Director, Dr. Dunham had been CVM’s Deputy Director.

Dr. Dunham also served as the Director of CVM’s Office of Minor Use and Minor Species from August 2006 to January 2008.  She came to CVM in December 2002 as the Deputy Director of CVM’s Office of New Animal Drug Evaluation.

Dr. Dunham is also an Adjunct Professor in the Department of Biomedical Sciences and Pathobiology at the Virginia-Maryland Regional College of Veterinary Medicine, a position she has held since 1996.  She lectures on a variety of topics from emerging issues and opportunities in veterinary medicine to the role of consensus building in policy development.

Janet Woodcock, Director, CDER, FDA

Dr. Woodcock has served FDA as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations and Chief Operating Officer.  In these roles, she oversaw scientific and medical regulatory operations.   Dr. Woodcock served as Director of the Center for Drug Evaluation and Research from 1994-2005.  She previously held other positions at FDA including Director, Office of Therapeutics Research and Review and Acting Deputy Director, Center for Biologics Evaluation and Research.   Dr. Woodcock received her M.D. from Northwestern Medical School, and completed further training and held teaching appointments at the Pennsylvania State University and the University of California in San Francisco.  She joined FDA in 1986.

Armando Zamora, Acting Director, Office of Enforcement, ORA, FDA

Armando Zamora is responsible for overseeing the operations and activities of the Office and ensuring that the Office of Enforcement’s mission supports FDA in protecting public health through the coordination and initiation of regulatory and recall actions, the review and management of compliance policies and processes, and the evaluation of data to assess and enhance agency compliance activities. Prior to becoming the Deputy Director, Mr. Zamora served as the Team Leader for the Recall Operation Staff from April 2008 to December 2010 in the Office of Enforcement. He also served as the primary liaison between ORA, the Centers, Office of Chief Counsel and the Office of Public Affairs for all matters pertaining to recalled products and recall management. Prior to this position, Mr. Zamora was a Consumer Safety Officer in the Division of Case Management, Office of Compliance and Biologics Quality, at the Center for Biologics Evaluation and Research from 1993 to 2008. Mr. Zamora was responsible for reviewing and evaluating information pertaining to compliance and enforcement activities, as well as activities related to recalls of products regulated by CBER. Prior to joining FDA in 1993, Mr. Zamora worked at the Washington Hospital Center, Washington, D.C., as a medical technologist in the clinical laboratory’s Immunohematology department.

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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