12TH ANNUAL PDA GLOBAL CONFERENCE ON PHARMACEUTICAL MICROBIOLOGY – GENERAL INFORMATION
Connecting People, Science and Regulation®
PROGRAM PLANNING COMMITTEE
A MESSAGE FROM THE PROGRAM CO-CHAIRS Dear Colleagues:
Program Co-Chairs: Kim Sobien PETNET Solutions | A Siemens Company Vinayak B. Pawar, PhD FDA
Edward S. Balkovic, PhD MicroBio Technical Support Julie Barlasov, MBA Merck & Co./Merck Sharp & Dohme Renée Blosser FDA Walid El Azab, Ind. Ph. STERIS Corporation Marsha Steed (Hardiman) ValSource, LLC Amy McDaniel, PhD Pfizer Inc. John W. Metcalfe, PhD FDA Michael J. Miller, PhD Microbiology Consultants, LLC Wendy G. Tan, PhD FDA CAPT Sharon K. Thoma, PharmD FDA Edward Tidswell, PhD Merck & Co./Merck Sharp & Dohme Radhakrishna S. Tirumalai, PhD U.S. Pharmacopeial Convention MaryEllen E. Usarzewicz, MS Bristol-Myers Squibb Eric J. Ward, MBA Boston Analytical Richard V. Levy, PhD PDA
On behalf of the Program Planning Committee, we extend a personal invitation to you to attend the 12th Annual PDA Global Conference on Pharmaceutical Microbiology. The Committee members were inspired to create a highly value-added agenda in light Kim Sobien Vinayak B. Pawar, PhD of the continuing changes PETNET Solutions | FDA to and challenges of global A Siemens Company pharmaceutical manufacturing that have emerged as the industry continues to grow. This Conference is designed to meet the unique needs of pharmaceutical microbiologists and interdisciplinary scientists involved in manufacturing and regulating the pharmaceutical industry. The agenda encompasses a wide variety of issues pharmaceutical microbiologists face and work in partnership to solve on a daily basis. An intriguing Conference keynote address will provide insight into the current dilemma of the alarming rate of antimicrobial resistance reported in patients. With fewer new antibiotics on the horizon and our need for alternative approaches, the focus will be on the potential use of vaccines to combat resistance, thus opening new doors for biotech manufacturing and microbiological testing. In subsequent sessions, you will hear case studies from industry experts about overcoming manufacturing obstacles when drugs, delivery devices, and biologics are combined to create new products. Regulatory experts will explain the complexities involved in ensuring that combination product regulation is as clear, consistent, and predictable as promised. Day one culminates with fresh perspectives and case studies of using teamwork to solve unique microbiology mysteries in the inspiring “Emerging Leaders” session. Day two of the Conference opens with the insightful real-life story of a microbiologist prevailing in a life-threatening battle against bacteria. The Committee’s own Marsha Steed (Hardiman) will deliver a unique perspective of her medical journey and reliance on the quality, safety, efficacy, and sterility of multiple pharmaceutical and medical device products manufactured by our industry. New this year is a U.S. FDA update on human drug compounding. An all-U.S. FDA speaker panel will address the unique needs of this industry, focusing on developing regulatory policy, facility inspections, cGMP requirements, and compounded drug quality. This is an essential session for attendees involved with outsourcing facilities and interested in the advancement of regulatory policy. Day three offers an introduction to the new path for pharmaceutical inspections in Europe and beyond through the U.S. FDA’s new Mutual Reliance Initiative and the much-anticipated “Ask the Regulators” panel session, where the audience can interact with highly regarded regulatory professionals and get answers to their most pressing microbial questions.
Molly O’Neill Moir, CMP PDA
The program will connect industry, academic, and regulatory professionals at all levels to achieve a unified goal of learning through sharing of best practices, development of standards, and integration of innovative technologies.
Brooke Schneider, CMP PDA
Please join us October 16-18 in Bethesda, MD for this always-popular interactive learning opportunity!
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