This webinar will explain the similarities and differences that exist for device and drug studies in the US and EU and the nuances of study conduct.
- Identify clearly the similarities in conducting device and drug studies
- Identify clearly the differences in conducting device and drug studies
- Understand more about device study nuances, conduct and regulations
Kimberly D. Hunsicker, MSN, CRNP, MBA, Vice President, Global Medical Devices & Diagnostics, Premier Research
Ms. Hunsicker comes to Premier Research with extensive leadership experience in global clinical trials. Most recently she was Senior Director, Global Clinical Operations at LifeCell Corporation, Bridgewater, NJ, where she was responsible for all global clinical research and development activities, the execution of complex strategic clinical plans and compliance with regulatory requirements worldwide. Perhaps even more important, she demonstrated a consummate ability to foster cross-functional relationships, communication and cooperation.
Prior to that Ms. Hunsicker was a principal at CRD Consulting in Philadelphia and a Vice President, Global Clinical Operations at Allergan Medical in Goleta, CA. She received an MBA in general management from Moravian College, Bethlehem, PA and Master of Science in Nursing degree as a Certified Registered Nurse Practitioner from Villanova University, Villanova, PA.
Victoria Cavendish, BSc(Hons), MPhil, PhD, PGDipPH, MICR, CSci, Senior Director, Devices, Premier Research
Victoria Jane Cavendish comes to D-Target with over 10 years experience in academia, health service and private sector medical device and Pharmaceutical corporations. She has a global perspective, a solid background in clinical research project management, and a thorough understanding of the nuts and bolts of identifying and satisfying customer needs. She also has a remarkable ability to build effective teams and get the job done.
Previously, as Global R&D Senior Clinical Project Manager, Health Wellbeing Category, Reckitt Benckiser, Hull, UK, Dr. Cavendish established and integrated the Clinical Health Wellbeing team and implemented regulatory and post-marketing clinical programs to support all medical devices within the company’s portfolio.
She is a contributor to The Challenges of Conducting Medical Device Studies (ICR Publishing, 2006), the author of numerous articles and poster presentations, a member of Chartered Scientist (CSci), and since 2012 chair of the Medical Device Subcommittee at the Institute of Clinical Research (MICR).
Dr. Cavendish received a Post Graduate Diploma in Public Health from the University of the West of England; a Doctor of Philosophy in Respiratory Immunology from the University of Bristol; a Master of Philosophy in Diabetes/Immunology from the University of Manchester; and a Bachelor of Science (Honours) in Immunology from the University of Glasgow.
Who Should Attend?
VPs, Directors, Managers, Department Heads, Scientists and Researchers working within:
- Clinical Affairs
- Clinical R&D
- Clinical Research
- Clinical Pharmacology
- Clinical Operations
- Project Management
- Regulatory Affairs
- Medical Affairs
for pharmaceutical, biotechnology and medical device companies
Premier Research is a leading global contract research organization serving biotech, Pharmaceutical and medical technology companies. The company’s D-TARGET medical devices and diagnostics unit has conducted more than 340 clinical research projects and recruited 35,000 patients.
The company has a wealth of experience in rare disease and pediatric research having managed about 100 projects in each area in the last five years alone. Its services include clinical research and regulatory outsourcing in the areas of analgesia; neurology; infectious, cardiovascular, and respiratory disease; dermatology; oncology; and medical devices.
Premier Research has 21 offices (seven in North America, 14 in Europe) and operates in 23 countries. It employs 1,200 clinical professionals dedicated first and foremost to fulfilling each customer’s requirements in a timely, accurate, and cost-effective manner. This includes a strong international network of monitors and project management professionals combined with regulatory, data management, statistical, scientific, and medical experts, and staff at its well-established network of dedicated clinical sites.