Kavita Aulakh is employed as Compliance Officer at the Kare Pharmacy & Compounding where she oversees pharmacy’s activities to ensure compliance with ethical, legal, and regulatory standards. She contributes to obtaining and maintaining accreditation and registration / licensure. The pharmacy has presence in 28 states and is accredited by Pharmacy Compounding Accreditation Board (PCAB) and Utilization Review Accreditation Commission (URAC) for mail services. In addition to conducting internal audits and responding to PBM audits; she writes policies and procedures for the organization.
Earlier, she had served in the capacity of Performance Improvement Coordinator, Quality Control Analyst and Laboratory Manager at the Kare Pharmacy & Compounding. She had also worked at UGA as a Molecular Biologist under the title of Research Professional and Laboratory Coordinator. In addition, she is an experienced teacher and had taught at various levels including School, College and Undergraduates at the University.
She has a master’s degree in International Biomedical Regulatory Sciences from The University of Georgia, a master’s degree in Molecular, Cellular and Developmental Biology from The University of Louisville, a bachelor’s degree in Education, a bachelor’s degree in Botany and a Diploma in Multimedia.
Kavita actively participates in the outreach programs. She is a Medical Reserve Corps Volunteer at Virginia Department of Health (VDH) where she served as a non-medical staff at COVID-19 vaccine point of dispensing centers. This is her third term serving as a committee member of the Medical Devices Regulatory Conference.
Michael G. Bartlett
Michael G. Bartlett is the Georgia Athletic Association Professor in Pharmacy and Associate Dean for Science Education, Research and Technology at the University of Georgia, College of Pharmacy. His research program focuses on the development of novel bioanalytical methodology to advance drug development including oligonucleotides, proteins and small molecule therapeutics. He also has served as the chair of the program committee for the UGA/FDA International GMP Conference since 2015.
James Bertram is currently the associate director with the Regulatory Policy and Combination Products Staff which supports the Office of Product Evaluation and Quality in CDRH. In addition, he serves as a product jurisdiction officer representing CDRH across the FDA. In this capacity James collaborates across the Agency on cross-cutting policies, many of which apply to the review and regulation of combination products. After receiving a BS in Mechanical Engineering from Pennsylvania State University and a MS/PhD in Biomedical Engineering from Yale University, James joined the FDA in 2009 as a Regenerative Medicine Fellow in the Commissioner’s Fellowship Program.
Trang Cox is the Supervisory Consumer Safety Officer for Division II Office of Medical Device and Radiological Health (OMDRHO). She began her career with FDA in 2009 as a Consumer Safety Officer in the Atlanta District Office as a fresh grad from the University of Georgia. She was fast tracked and conducted technical and complex inspections for Medical Devices. Trang became Supervisory Consumer Safety Officer in 2014 in the Atlanta District Office and covered the Medical Device program and staff. She was also one of the New Hire Training cadre members and has worked co-operatively with other District’s management to perform the functions of a District Training Officer. She also served on the Subject Matter Expert Panel for the Medical Devices Grade Elevation including other workgroups for the Device Program after Program Alignment. Prompted by COVID-19, Trang served as the senior lead for the Remote Regulatory Assessment Strategic Priority Workgroup for OMDRHO. She is one of the members of the first cohort of the Leadership Excellence Advancement Program (LEAP) and has served on a detail as Acting Director of Compliance Branch and Acting Director of Investigation Branch for Office of Medical Device and Radiological Health Operations/Division II and was promoted in 2018. In her current position, Trang supervises a team of Investigators conducting domestic and foreign operations.
Richard has in depth knowledge of regulatory, clinical and quality activities, with extensive experience of bringing medical devices of all classesto market, including strategic regulatory discussions with notified bodies, competent authorities and FDA. At Medidee, Richard takes the lead on clinical and scientific related processes. Clinical process specialities include Clinical Evaluation, Clinical Investigation design, Clinical Development Planning, including PMCF. Related to Scientific Process within Medidee, this includes specialisation in biological evaluation and biological safety assessment, assessment of substance-based devices according to GSPR 12, cleaning validation, sterilisation validation, processing validation, together with the design of usability and animal study design as part of V&V activities.
Richard holds a PhD in the development of biomarkers of dietary intake, in colitis patients. For over 7 years Richard worked as a Technical Manager in the dental and orthopaedic field, responsible for the manufacture and quality assurance of medical devices to ISO 13485 and GMP standards, working closely with clinical and R&D functions to bring implantable medical devices to market. Before this he worked as a Project Leader in the area of bio-analytics focusing on testing and validating pharmaceutically active ingredients as well as cosmetic products. Richard has worked as senior consultant for 6 years with Medidee, providing a range of clinical and scientific services for a diverse range of devices used to treat a multitude of pathologies. Richard’s other duties include the development of processes related to emerging requirements in the medical device sector, as well as the coaching and development of colleagues for the processes he specialises in.
John joined MCRA on August 31st, 2020 as Senior Director, Neurology Regulatory Affairs. At MCRA, John provides guidance on regulatory strategies and submissions development for MCRA’s neurology clients, as well as interacts on breakthrough device designation submissions and strategies across various therapies. He has extensive knowledge of medical device regulatory pathways to drive technologies from conception to market. John is a neuroscientist and biomedical engineer with 10+ years of FDA experience in medical device regulation, and 13+ years of Johns Hopkins experience in discovery science, and 6+ years of management experience at FDA and Johns Hopkins School of Medicine.
Prior to joining MCRA, John was the Former US Food and Drug Administration (FDA) Policy Lead, for the Breakthrough Device Program. In this position, John managed the Breakthrough Device Program, where he oversaw all aspects of the program, was involved in the granting or denial of all Breakthrough designation requests, and served as CDRH’s expert for internal and external stakeholders regarding the regulatory standard for obtaining the Breakthrough designation for a medical device.
In addition to John’s leadership role with the FDA Breakthrough Designation Device Program, John also served in additional roles at FDA including Acting Director of IDE Program, Lead Reviewer of Neurology and Physical Medicine Devices, Acting Branch Chief of Neurostimulation Devices Psychiatry Branch, and Policy Analyst of Office of Device Evaluation.
Philippe Etter is the Founding partner of Medidee – a leading Swiss consulting firm specializing in Regulatory, Quality and Clinical affairs services within the medical device industry. He has served in the MedTech compliance and innovation sector for 27 years and is currently driving the USA operations in New Jersey. His background includes experience as a hardware and software development engineer in the field of biological components separation for a USA based company. Medidee serves on ten sites throughout Europe and the USA, located around the areas of active MedTech innovation. One of the key missions is to support American companies on their way to the EU markets with the current transitions of the EU regulations. Philippe’s expertise includes strategic and tactical consulting on regulatory and clinical pathways for critical products such as active medical devices, AIMD, extra corporal circulation, implants and IVD. To better serve the community, Philippe leads in three European Universities a set of continuous training programs preparing leaders for current and upcoming MedTech challenges. Philippe holds an MSc in micro technology from Swiss Institute of Technology and a level III European certificate in medical devices sterilization.
Seppe De Gelas
- Located / based near Brussels in Belgium (Europe)
- Peptide chemist by education (Free University of Brussels)
- Started my career +25years ago in clinical research (Bristol-Myers Squibb) , evolved into Quality Assurance and Regulatory Affairs of several pharmaceutical production units (Baxter International, Belgian-based HQ of UCB & Lonza)
- Between 2010 & 2015 owned my own laboratory doing QC testing & batch release for the European market.
- Latest responsibilities included auditing a myriad of pharmaceutical and medical device suppliers and subcontractors and a QA & RA director position at a medical device ISO13485 certified start-up company, developing a sub-cutaneous continuous glucose sensor.
- Currently holding a position as director QA & regulatory affairs at Hyloris Pharmaceuticals, a virtual pharmaceutical company focusing on products using FDA’s 505b2 regulatory approval pathway.
- Faculty member of the UGA since 2017 teaching various classes including European regulatory affairs and Process control & Process validation.
Mike currently oversees the OPEQ Shortages Team for OPEQ in CDRH, including responsibilities related to shortages and policies regarding EUA and PEUAs. He works with stakeholders across CDRH, who are collectively focused on developing tools, processes, and policies for identifying and mitigating device shortages in the future. Mike has worked at CDRH since 2007 originally in Office of Device Evaluation (ODE) in the area of neurological devices including various forms of neurostimulation, neurodiagnostics, and rehabilitation, providing review of several different types of medical devices before they are marketed and before many are studied in clinical trials. He subsequently served as a Branch Chief, Deputy Division Director, and Associate Office Director for Policy within the Office of Neurological and Physical Medicine Devices, which included oversight and policy recommendations of premarket activities for a wide variety of devices associated with neurology and rehabilitation including but not limited to prosthetic limbs, brain-computer interface systems, rehabilitation robotics, powered exoskeletons, neurosurgical tools, stereotaxic systems, neurodiagnostic systems, and neurointerventional devices as well as a wide variety of implanted and external neurostimulation systems. Michael received his B.S. in Electrical Engineering from the University of Illinois in Urbana-Champaign and his M.S. in Biomedical Engineering from Marquette University.
In addition to his instructional role at The University of Georgia Institute for International Biomedical Regulatory Sciences, Al is the Vice President of Quality Assurance at Axogen Incorporated. Al has over 25 years of Quality and Regulatory experience, including serving in leadership roles at a variety of pharmaceutical and medical device companies, including Glaxo (now GSk), J&J, and CR Bard; as well as successful start-ups CorMatrix, Alimera Sciences, and VERO Biotech. His regulatory experience includes numerous NDA and 510(k) submissions, and he is passionate regarding achieving and sustaining consistent regulatory compliance. He has successfully implemented multi-site global quality management systems that meet FDA and international compliance requirements for pharmaceuticals, medical devices, and combination products, and is passionate about developing Quality Management Systems that achieve global regulatory compliance using a data-driven approach. Al is also a mentor who enjoys helping talented people capitalize on their strengths so they can best contribute to both their personal and company success.
Ms. Angela Krueger serves as the Deputy Director for Regulatory Policy for the Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA). In this position, she provides leadership for scientific and policy issues that impact the premarket and postmarket review of medical devices. Ms. Krueger provides oversight and strategic direction for OPEQ’s policy, guidance and regulation development programs, implementation of statutory provisions, and policies and processes for combination product review. Ms. Krueger has worked at the FDA for 18 years and has previously served in the former Office of Device Evaluation (ODE) as the Deputy Director for Engineering and Science and Associate Director for Regulations and Guidance; a Regulatory Advisor and Policy Analyst; the CDRH Product Jurisdiction Officer; and a Scientific Reviewer in the Division of Cardiovascular Devices. Ms. Krueger holds degrees in Chemistry and Journalism from Butler University, Indianapolis, Indiana.
Michael Maier has 20+ years of hand on experience within medical device industry in design & development projects, product industrialization and regulatory & quality affairs. Michael is a trained Notified Body auditor for ISO 13485 and MDD and has served numerous international compliance programs. Michael helps clients determining the most appropriate regulatory pathways and strategies to bring medical devices to markets. Michael supports you with regulatory troubleshooting and compliance audits for product files, clinical investigation files and quality systems. Michael is fluent in German, French and English.
Michael holds an MBA in corporate management, a master in Medical Engineering and a Swiss Certificate of Capacity as precision mechanic. He earned his RAC Devices in 2019. Michael is member of several standardization committees related to Medical Devices. Regularly, he is speaker in international events for medical devices, quality and regulatory affairs topics.
Dr. McMeekin is the Associate Commissioner for Regulatory Affairs (ACRA) within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). She has responsibility for over 5,000 staff and operations in ORA. ORA is FDA’s “field force” supporting FDA’s product centers through responsibilities including, inspections and investigations, including criminal investigations, compliance and enforcement, import operations, regulatory science and field laboratory operations. ORA also works closely with global, federal, state, local, tribal and territorial partners, and administers contracts, grants and cooperative agreements to advance an integrated system and ensure an effective public health safety net.
Prior to becoming ACRA, Dr. McMeekin served as the Deputy Associate Commissioner for Regulatory Affairs, Acting Director of ORA’s Office of Strategic Planning and Operational Policy and as the Director, Division of Operational Policy. Dr. McMeekin began her FDA career in the Center for Drug Evaluation and Research in the Office of Compliance, eventually serving as the Director, Division of Prescription Drugs. Before joining FDA, she worked for the United States Pharmacopeia, and several health systems as a clinical pharmacist.
Dr. McMeekin received her Bachelor of Science degree in pharmacy and her Doctor of Pharmacy degree from Northeastern University in Boston, MA.
Ayishwariya Menon has over 13 years of experience in the medical device industry in engineering, product development, program management, business development and regulatory affairs. She began her career in research and development for planning, navigation, and robotics for orthopaedic surgical interventions in a start-up environment. This was followed by a 10-year tenure at Materialise, a leader in the additive manufacturing industry, where Ayishwariya worked on several innovative additive manufactured medical devices that are successfully being used by clinicians today. Her experience there spanned several areas having transitioned from roles in product development in Belgium to business development and team management in Malaysia before overseeing a large and complex product and process development program in the USA. Over the years Ayishwariya has been involved with several submissions to the FDA and is currently a consultant to the medical device industry, supporting their product development, project management and regulatory needs. She is a member of the Project Management Institute and has maintained her PMP® certification since 2018. Ayishwariya holds an MEng. degree in Biomedical Engineering with Electrical and Electronic Engineering from Imperial College London.
Melissa Gaynor O’Connor
Melissa Gaynor O’Connor, M.S., RAC, CTBS has over 20 years of experience in medical device, combination product, and human tissue new product development research, engineering, and commercialization. She has over 10 years of experience in Quality System design, implementation, maintenance, and compliance. Prior to joining StimLabs, Melissa held Quality leadership positions serving as the Management Representative, Head of Quality, and Official FDA correspondent for prescription eye-glass lens manufacturer QSpex Technologies, Inc., and Chemence Medical Products, Inc., a global manufacturer of adhesive based Class II medical devices for wound closure. During her 11 year tenure with Kimberly-Clark Health Care, Melissa held positions in Regulatory Affairs, Product Development, and Process Engineering. In addition to Quality Systems expertise, Melissa is skilled at developing comprehensive regulatory strategies to support new product development including pre-market approval requirements for the U.S and E.U. She is a member of both the Regulatory Affairs Professional Society (RAPS) and the American Association of Tissue Banks (AATB), and also holds active RAC and CTBS certifications. Melissa holds a B.S. degree in Biological Sciences from the University of Georgia and a M.S. Degree from the University of Georgia School of Pharmacy in Biomedical and Pharmaceutical Regulatory Affairs.
Batul Patel is the Director for Digital Health Center of Excellence, at the Food and Drug Administration (FDA). Mr. Patel is responsible for providing leadership, development, implementing, execution, management and setting strategic direction and regulatory policy and coordinate scientific efforts for digital health, software and emerging technologies.
Mr. Patel, in 2013, created the term “software as a medical device” (SaMD) and under his leadership the International Medical Device Regulators Forum (IMDRF) established the globally harmonized definition of SaMD. Mr. Patel subsequently led global regulators at IMDRF to create and author the globally harmonized regulatory framework for SaMD. The concepts, principles and vocabulary created in harmonized regulatory framework has been used as a foundation and adopted by medical device regulatory bodies in the European union, Japan, Canada, Brazil, Australia and in the USA by US-FDA.
Mr. Patel is currently leading the effort for the agency in developing an innovative software precertification program to reimagine a pragmatic regulatory approach for Digital health that that aims for patients and providers to have timely access to safe and effective digital health products.
Prior to joining FDA, Mr. Patel held key leadership positions in several sectors including telecommunications industry, semiconductor capital equipment industry, wireless industry and information technology industry. His experience includes Lean Six Sigma, creating long and short-term strategy, influencing organizational change, modernizing government systems, and delivering high technology products and services in fast-paced, technology-intensive organizations. Mr. Patel earned an MS in Electronic Systems Engineering from the University of Regina, Canada, and an MBA in International Business from The Johns Hopkins University.
Tony has been with BSI for 19 years and is currently AVP of Medical Devices – Development, for BSI -Regulatory Services-Medical Devices. Initially starting as a national and global accounts manager, his role evolved to training and support of the commercial staff and operations especially around more complex organizations, restructuring, and consolidations, as well as to handle occasional special projects. He has been a key member of the team that developed the MDSAP program implementation at BSI starting in 2013 and continues to be actively involved as the program evolves. He has helped guide organizations through transitions such as ISO 9001:2015, ISO 13485:2016, MDR and IVDR.
Prior to joining BSI he spent 24 Years in the Quality industry, 6 of those years as a consultant focusing on Quality Management Systems for international companies in automotive and medical device areas. He worked 18 years in the Asia-Pacific region with a technical services organization in the industrial projects, inspection, testing laboratory, marine and cargo supervision business, in operational, administrative, and management positions, serving the last 8 years as president of the consolidated group.
Tony holds a Master’s Degree in the Management of Technology from MIT.
Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs external seminars, webinars and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has many published articles on biocompatibility topics.
He is a participating member on all Association for Advancement of Medical Instrumentation (AAMI) TC 194 and 10993 ISO committees and plays an active role along with the FDA and regulatory committees developing standards, discussing biocompatibility methods and voting on changes to those standards. As one of a select group of experts in the industry, Thor’s participation on the committees offers him insight on industry changes and helps prepare clients for changes in testing.
Jeffrey Shuren, MD, JD is the Director of the Center for Devices and Radiological Health (CDRH) at FDA. He previously served as Acting Center Director. Dr. Shuren has held various policy and planning positions within FDA from 1998 to 2009, including Acting Deputy Commissioner for Policy, Planning, and Budget; Associate Commissioner for Policy and Planning; and Special Counsel to the Principal Deputy Commissioner. Dr. Shuren is board certified in Neurology and served as an Assistant Professor of Neurology at the University of Cincinnati. In 1998, Dr. Shuren joined FDA as a Medical Officer in the Office of Policy. In 2000, he served as a detailee on the Senate HELP Committee. In 2001, he became the Director of the Division of Items and Devices in the Coverage and Analysis Group at the Centers for Medicare and Medicaid Services. From 1998 to 2003, he served as a Staff Volunteer in the National Institutes of Health’s National Institute of Neurological Disorders and Stroke Cognitive Neuroscience Section supervising and designing clinical studies on human reasoning. Dr. Shuren returned to FDA as the Assistant Commissioner for Policy in 2003, and assumed his current position in September 2009.
Kathleen M. Sinninger
Kathleen Sinninger is the Director of Investigations for Office of Medical Devices and Radiological Health Program (OMDRHO) Division 2, and is currently acting as Program Division Director for Division 2. The Investigations branch includes a staff of 65, including 7 Supervisory Teams and 50 consumer safety officers. Ms. Sinninger began her career with the FDA in 1991 as an Investigator in Richmond, VA. As an Investigator, she gained experience conducting inspections in all program areas. In 1997, Ms. Sinninger was promoted to the position of Supervisory Investigator in Miami, FL. While in Miami, she also served as the Acting Import Branch Director for one year. In June 2005, Ms. Sinninger moved to Maitland, FL to become the Director of Investigations Branch for Florida District. Ms. Sinninger was assigned to the Medical Device program when the Office of Regulatory Affairs initiated its Program Alignment in 2017.
Kelly M. Smith
Kelly M. Smith is Dean of the College of Pharmacy at the University of Georgia. Serving as the first female dean in the College’s more than 115-year history, she has overseen several key initiatives since joining the College in August 2018, including developing and implementing a five-year strategic plan; more than doubling research funding; intensifying and expanding Diversity, Equity, and Inclusion; and increasing the number of degree offerings, among others. These advances led to the College’s elevation in the U.S. News and World Report rankings to 24th among more than 140 colleges of pharmacy in the nation.
A native of Statesboro, Georgia, Dean Smith is a proud alumna of the College, graduating in 1992 with a B.S. in Pharmacy degree and in 1993 with a Doctor of Pharmacy degree. Prior to returning to her alma mater as Dean, she served for more than 24 years at the University of Kentucky College of Pharmacy in various capacities, including Associate Dean for Academic and Student Affairs and Interim Dean of the College.
An academic leader with a record of advancing research and pharmacy education, Dean Smith is a past President and Fellow of the 55,000-member American Society of Health-System Pharmacists (ASHP), one of the largest pharmacy membership organizations in the world. She currently serves as Vice Chair of the Board of Directors of the ASHP Foundation, the philanthropic arm of ASHP. She also is a Fellow of the American College of Clinical Pharmacy and received the Zeta Tau Alpha Foundation’s 2018 Outstanding Alumna Award in recognition of her national leadership in Pharmacy and Pharmacy education.
Mr. Solis is a recognized expert in FDA import operations who has served as the acting assistant commissioner and director of ORA’s Office of Enforcement and Import Operations (OEIO) since March 29, 2020. During this time, he has provided leadership and direction to all OEIO field import divisions as well as the Division of Food Defense Targeting and Division of Import Operations at FDA HQ. He brought about the leadership and stability needed during the COVID-19 Pandemic. Mr. Solis was selected as the Assistant Commissioner for Import Operations on November 22, 2020 and prior to that he was the Division Director for the Division of West Coast Imports since February 9, 2018.
He started his career with FDA in 1998. Prior to working in FDA, Mr. Solis worked in the Bioresearch field focusing on Medical Device and Drug Application Products after graduating from the University California of Irvine and the University of La Verne. Mr. Solis has held many positions within FDA that includes working at the FDA lab in Irvine, Ca. as a Microbiologist, HQ position within the Division of Import Operations in Rockville, MD, working as an Import Compliance Officer and working in the FDA Los Angeles District Office as a Director of Import Operations Branch.
Mr. Solis is an experienced collaborator who has played an integral role in FDA operational activities with other federal agencies, partnering with Customs and Border Protection, Homeland Security Investigations, U.S. Department of Agriculture, U.S. Fish and Wildlife Service, Drug Enforcement Agency, and state and local law enforcement agencies. Additionally, he conducts local and national training on imports, is a member of the National Leadership Development Workgroup at FDA’s Office of Training and Education Development, and has served as a mentor for the Federal Executive Board in Los Angeles and ORA’s Potential Supervisors Program.
In his new role, Mr. Solis serves as the principal advisor to Associate Commissioner for Regulatory Affairs and report to the Deputy Associate Commissioner for Regulatory Affairs (DACRA) on all import matters. This includes providing direction and oversight to FDA field import operations, reviewing prior notice and intelligence data on human and animal food, and leading the development and implementation of new import programs and procedures.
Mr. Solis has had many accomplishments within FDA and these are a few notables: Implementation of PREDICT at all ports in the US, the implementation of electronic communications and paperless transactions initiatives with the Trade Associations, formation of the CBP/FDA Teams including the Opioid Task Force, formation of the West Coast Import Advisory Council, formation of Federal and State Task Forces, conducting Federal Operations, streamlining the refusal process in the Ports of LA, San Francisco and Seattle, and development of strong partnerships with the filers, brokers and importers in the Pacific Region.
Mr. Solis is nationally recognized as a subject matter expert in the program area of Import Operations and gives local, as well as, national training on Imports Investigations. He is a member of the National Leadership Development Workgroup at FDA’s Office of Training and Education Development, has served as a mentor for the Federal Executive Board in Los Angeles and the Potential Supervisor Program within FDA. He also has had integral roles in FDA Operations with other Federal Agencies, working with CBP, HSI, USDA, FWS, DEA and State and local law enforcement agencies. Currently, aside from his duties at the port, Mr. Solis is also a member of the FSMA – Foreign Supplier Verification Program (FSVP) Implementation Team as well as the Associate Commissioner’s IT Advisory Workgroup, the Associate Commissioner’s Import Advisory Panel, member of AFDO, WAFDO, ASQ, OCRA and the Pacific Island Health Officers Association (PIHOA).
Mr. Solis holds a Masters Degree (MS) in Healthcare Administration from the University of LaVerne and a Bachelor’s Degree (BS) from University California of Irvine.
LT Colin Tack serves as a Medical Device Investigator / Regulatory Officer in ORA’s Office of Medical Device and Radiological Health Operations (OMDRHO) Division 1 in Jamaica, NY. In this role he primarily conducts medical device inspections. Prior to joining ORA/OMDRHO in 2018, LT Tack served as a Lead Reviewer for several years in FDA’s Center for Devices and Radiological Health (CDRH) Office of Product Evaluation and Quality (OPEQ), where he reviewed pre-market applications for various cardiovascular devices and combination products. LT Tack is an active duty commissioned Engineer Officer in the U.S. Public Health Service. He earned his Bachelor of Science degree in Bioengineering from Syracuse University and is currently pursuing a Graduate Certificate in Global Health and Global Health Engagement at the Uniformed Services University of the Health Sciences (USUHS).
Kimberly A. Trautman is an experienced Medical Devices, InVitro Diagnostics, and Combination Product Expert with over 30 years of experience. She worked at the US Food and Drug Administration (FDA) for 24 years and continues to work with Regulatory Agencies around the globe. Industry experience as well as regulatory agency experience. Demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. Executes several medical device regulatory services and developed a formal Education/Training business. Established an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body for EU IVDR/MDR Designation.
Expert in global medical device regulations, wrote and harmonized the current US FDA Quality System Regulation and was on the international authoring group of ISO 13485 since inception. Conceived and developed the Medical Device Single Audit Program and its consortium of five Global Regulators. Twenty-year veteran of the Global Harmonization Tasks Force (GHTF) and foundational member of the International Medical Device Regulators Forum (IMDRF). Recognized International Medical Device expert with a Master’s Degree in Biomedical Engineering.
Kim Walker is an independent Global Regulatory Affairs, Quality Assurance, and Clinical Affairs Consultant and owner of Kim Walker Consulting since 2006 with over 28 years of industry experience. In her consulting practice, she assists clients with pre- and post-market regulatory, clinical, and quality system needs for IVD, dietary supplement, biologic, pharmaceutical, combination, and medical device products. Recently, she assisted WHO as an Innovation COVID19 Response Team Consultant and Operations Support and Logistics Supply Team Consultant, where she evaluated regulatory and quality system preparedness for COVID-19 medical devices and IVDs for WHO placement in underserved countries. Kim is active in non-profits, serving on the board of directors and various committees, and has managed, moderated, and presented at several professional conferences. She is an instructor at SDSU, CSUF, and Roseman University for both graduate and undergraduate level regulatory courses. Kim achieved both the US and EU RAPS RAC and has been accepted as a RAPS Fellow in recognition of her contributions and leadership in advancing the regulatory profession. Additionally, Kim received the 2008 Leonard Stauffer Award from RAPS in recognition of her contributions to mentoring and furthering regulatory professional education development. She received a Leveraging Collaboration Award from the FDA for being the industry originator of the LOS-DO Quality Leadership Network (QLN), helping to bridge communication and collaboration opportunities between FDA and industry and she was awarded an OCRA lifetime membership for her contributions to the organization. She has a Bachelor of Science degree in Bio-Medical Sciences and a Master of Science degree in Regulatory Affairs.
Qianqian is the Director of International Regulatory Affairs at Immucor, Inc. In this role, she is responsible for the management of international regulatory requirements, including product registration, compliance to importation regulations and post-market vigilance. She supports cross-functional teams within Immucor for product commercialization planning and market strategies. Over the past seven years, Qianqian has successfully led the registration of 20+ Class III Medical Devices and In-Vitro Medical Devices (IVD) with China’s National Medical Products Administration (NMPA); covering product testing and clinical trials. Qianqian participated in the development of five technical evaluation guidelines for China’s Center for Medical Device Evaluation (CMDE); and a number of national standards with China’s National Institute for Food and Drug Control (NIFDC). Qianqian was a key speaker at The RAPS Convergence 2017 Conference delivering “The Art of Getting NMPA Premarket Approval in the Shortest Time Possible”. Qianqian serves as the Director of the Chinese Regulatory Affairs Professional Society, a non-profit organization in Boston, MA. Qianqian holds a Masters in Business Administration, a Master of Laws (LL. M.) and an RA graduate certificate from The University of Georgia. Qianqian is working towards completion of a masters degree in International Biotechnology Regulatory Affairs. Qianqian is Regulatory Affairs Certified (RAC). Prior to her career in the US, Qianqian received her BA in Law from China and practiced law at the JunZeJun law offices in Beijing.