Trista Schoonmaker, PCC – COPIA Coaching and Consulting ### 593803###Facilitator @@@ Virginia Ann Swassing, RAC (US and EU) ### 593804###Facilitator
9:00 AM - 5:00 PM
Developing Your Global Medical Device Regulatory Strategy
9:00 AM - 5:00 PM
Developing Your Global Medical Device Regulatory Strategy Location: 201 A Nicole Landreville, P.Eng, RAC, FRAPS – GE Healthcare Madison WI USA (Madison, WI); Megha Iyer, MS, RAC – Thermo Fisher Scientific; Bradley Hossack, Bsc – Stryker - ENTERPRISE; Patrick Lee, PE, MS, MBA, RAC – BioCardia Inc.
Connie Angela Del Buono – Synoptyx Inc. ### 574722###Workshop Leader @@@ Lorry W. Huffman, MT (ASCP), CLS – Qserve Group US. Inc ### 573387###Speaker @@@ Simon Richards, PhD – Abbott Rapid Diagnostics ### 585116###Speaker @@@ Andreas Stange, PhD – TÜV SÜD Product Service GmbH ### 585266###Speaker @@@ Anja Wiersma, PhD ### 574723###Speaker
9:00 AM - 5:00 PM
Pediatric Drug Development Regulatory Strategies for Global Success
9:00 AM - 5:00 PM
Pediatric Drug Development Regulatory Strategies for Global Success Location: 201C Kimberly Belsky, MS; Karl-Heinz Huemer, MD, PhD – AGES (Austrian Agency for Health & Food Safety); Linda McBride, R.Ph., RAC – Regulatory Professionals Inc; Dara Wambach, MA – Regulatory Professionals Inc
Jennifer Owen-O'Quill, MDiv ### 720624###Workshop Leader
9:00 AM - 5:00 PM
Demystifying the EU MDR: From Transition to Implementation
9:00 AM - 5:00 PM
Demystifying the EU MDR: From Transition to Implementation Location: 204C Bassil Akra, M.Sc, PhD – TUV SUD Product Service GmbH; Sabina Hoekstra-van den Bosch, PharmD FRAPS – Central Committee on Human Research; Erik Vollebregt, LLM – Axon Lawyers; Mindy McCann – Qserve Group Inc. - ENTERPRISE; Rita Guzzetta, MBA – Medtronic Inc.; Joanna Develter – Edwards Lifesciences; Melissa Day, RN, BSN, MBA – Johnson & Johnson; Gert Willem Bos, FRAPS – Qserve Group Inc. - ENTERPRISE; Alexandra Jantzen Schroeder, PhD – BSI - ENTERPRISE; Philippe Auclair, Pharma Dr, PhD , FRAPS – Abbott - ENTERPRISE
