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The Orthopaedic Regulatory and Clinical Affairs Program at Grace College: A Joint Partnership


 

 

Meet Our Faculty, Learn Their Credentials
Mikhail Chkolnik is the project leader for clinical research at Depuy Orthopaedics. He holds a Doctorate in family medicine and specializes in therapeutic knowledge of cardiovascular and orthopaedic devices.

Rodrigo Diaz is the medical safety officer at DePuy Orthopaedics. He earned his Doctor of Medicine in Bogota, Colombia, with an emphasis in family medicine. He has worked over ten years in clinical research.

Jordan Lee is a manager with DePuy Orthopaedics. She holds a Doctorate in the field of biomedical device design and serves as an advisory council member for the Indiana Space Grant Consortium and the Technical Assistance Program at Purdue University.

Mark Piazza  practices law as the owner and managing director of Mark T. Piazza, LLC. He holds a Juris Doctorate and previously served as an assistant general counsel for Johnson & Johnson.
Pamela Plouhar is the vice president of worldwide clinical affairs at DePuy Orthopaedics. She earned her Doctorate in chemistry/biochemistry from the University of Notre Dame and holds ten published patents.

Max Sherman is the president of Sherman Consulting Services, Inc. He holds a Bachelor of Science in pharmacy and is the author and co-author of more than 100 professional publications in numerous pharmacy, regulatory and orthopaedic journals and books.

JoAnn M. Tyson is the CEO and clinical and regulatory affairs director at J. Tyson & Associates, Inc (JTA). JTA specializes in device clinical trials with an emphasis on orthopaedic and cardiovascular products and services. Ms. Tyson is a registered nurse and holds her Master’s in health care services administration. 

Paul Voorhorst is the director of worldwide biostatistics and data management at DePuy Orthopaedics. He holds an M.B.A. and a Master’s in biostatistics and has provided leadership in numerous Investigational Device Exemption and Premarket Approval submissions to FDA.

Ted M. Wendt is a consultant in regulatory affairs, compliance and quality assurance and holds a doctorate in microbiology. He retired as vice president of regulatory affairs and compliance from Zimmer in 2004. Prior to his tenure with Zimmer, he served as director of international regulatory affairs for Johnson & Johnson Medical, Inc.

Learn more about ORCA by attending Professor Decker’s session on Wednesday, June 13 at OMTEC 2012. Allyn will explain key features of the program, share highlights from the inaugural year and answer participant questions.

Apply for ORCA online.

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