May 18, 2011
CLE Credits Requested
Presented by a host of Indiana Medical Device Manufacturing Sector Experts:
4 Sponsorships Available
(Sponsorship includes promotions, signage at the event as well as a shared table for materials distribution. Sign up at the bottom of the Registration Form)
|8:00-8:30 am.||Registration / Continental Breakfast / Networking|
|8:30-9:00||Welcome/Overview||Ralph Hall, Counsel,
Baker & Daniels
|9:00-9:45||Clinical Trials and IDEs
|Keli Hankee, Manager, Clinical Affairs,
|10:00-11:00||Submissions||Colleen Hittle, Managing Partner
The Anson Group
|11:00-11:30||Combination Products||Suzanne O’Shea, Partner
Baker & Daniels
|11:30-12:00||Complaint Handling/Adverse Event Reporting
|Laura Lyons, VP, Clinical, Quality & Regulatory Affairs,
|12:00-1:15||Lunch and Networking||
|1:15-1:45||Corrections and Removals||Chris Kilander, Regulatory Manager/ Corporate Compliance Administrator
Cook Urological, Inc
|1:45-2:30||QSR Overview||Richeal Cline, Quality Director,
Roche Diagnostics (invited)
|2:30-3:15||Advertising and Promotional Controls||Danelle Miller, Regulatory Counsel
|3:30-4:00||Enforcement||Ralph Hall, Counsel
Baker & Daniels
|4:00-4:30||Emerging Trends and Panel Q&A||Panel of Prior Speakers|
Registration: 8:00 am
Program 8:30 – 4:30 pm
Location: Montage Catering Facility, 8580 Allison Pointe Blvd., Indianapolis, IN 46250
Members: $195 per person
(Member discounts apply when registering more than 4 attendees at the same time)
Non-Members: $275 per person
Pearl IRB is speaking on a panel and exhibiting at the ACRP Excellence in Clinical Research Fall Symposium – REGISTER NOW!
Don’t miss the Circle City ACRP Event
held on November 6, 2010
Who should attend:
All personnel who are involved in or planning to be involved in clinical research. This conference is targeted for both new and experienced clinical research professionals including research nurses, clinical research coordinators, investigators, site managers, IRB members, and Pharmaceutical & Medical Device representatives.
What will be covered:
The pursuit of excellence in clinical research will be presented from the perspective of each of the major clinical research stakeholders. Click here for full agenda and brochure.
Date:Â Â November 6, 2010
Time:Â 7:30am – 4:30pm
Where:Â Indianapolis, Indiana at the downtown University Place Hotel
This Event Has Been Approved for 7.5 Contact Hours
About Pearl IRB
Pearl IRB is an independent Institutional Review Board that provides comprehensive IRB services for institutions, principal investigators, and CRO’s nationwide.We deliver quality and timely reviews that balance the interests of human subjects, sponsors, and institutions. Together, we will drive enhanced efficiency and value in clinical research.To learn more, please visit us at www.pearlirb.com, call us at 317.278.4100, or email firstname.lastname@example.org.
Sponsored by: American Association for Clinical Chemistry
Contact: email@example.com / 202-857-0717
Who Should Attend
This two-day course is designed:
The objective of this course is to provide an overview of the preparation, design and management aspects of clinical trials for medical devices.Â Upon completion of this course, attendees will have an understanding of the unique challenges faced in clinical trials for medical devices, which will be useful in the future development of device technology.
This course will review challenges, roles and responsibilities of sponsors and investigators during the clinical development phase.Â Participants will learn the essentials of coordinating, monitoring, and managing a clinical trial with an emphasis on good quality product outcome and meeting ICH E6 for Good Clinical Practice.
The goal of the conference is to enhance the knowledge and skills of conference attendees in the conduct of clinical trials in order to evaluate the drug, biologic, and/or medical deviceâ€™s safety and effectiveness in treating, preventing or diagnosing a specific disease or condition.Â In addition to providing clinical research education and training, this conference acknowledges the dedication and excellence of its membership.
What is the difference?Â How do they affect us?Â Why do we have them?Â Click on the link and get registered today to find out more!!!
Come hear Fred McClure, currently Manager, Regulatory Compliance at Roche in Indianapolis, IN and responsible for recalls in the US.
Fred has 12 years of regulatory experience in Medical Devices.Â He spent 5 years in orthopedic implant industry and 7 years in the in-vitro diagnostic industry.Â He has a breadth of experience in the medical device regulatory field including experience in pre-market regulatory submissions (510(k), PMA and IDE), clinical trials, post market activities (complaint handling, medical device reporting and recalls), quality system management, internal auditing, supplier auditing, FDA 483 and Warning Letter remediation as well as review and approval of advertising and promotional materials.
Hosted by Clarian and Methodist Research Institute
Mark April 15th in your calendars for more than just Tax Day! Clarian / Methodist Research Institute (MRI), Indiana Health Industry Forum (IHIF) and Baker & Daniels are hosting a networking reception for members of the IHIF Clinical Trials Working Group and invited VIP guests.
Speaker Anantha Shekhar, M.D, Chair of the Indiana Clinic Research Committee and Director of the Indiana Clinical and Translational Sciences Institute, will address how the emergence of the Indiana Clinic will positively affect and impact research in Indiana. Cary Mariash, M.D., Medical Director of the Methodist Research Institute and a practicing physician at Indiana Clinic Endocrinology, will also be on hand to answer questions.
Date: Thursday, April 15, 2010
Time: 5:00 p.m.Â - 6:30 p.m.Â EDT
Methodist Research Institute
1812 North Capitol Avenue
Indianapolis, IN 46202
About the Conference
This conference program will bring together executives from industry to discuss and debate the challenges that they face in designing and conducting studies that support an increasing array of corporate goals. Keynote presentations will address topics of interest to clinical and reimbursement executives, on movements within the industry resulting in new evidence thresholds, as well as methods for bringing teams together throughout the product lifecycle to ensure targets are met.
Each afternoon, the audience will divide into break-out sessions that will focus more specifically on topics related to clinical research or reimbursement
Topics to Include:
Clinical Study Breakouts
Reposted from Manufacturing & Technology eJournal:
FAST Diagnostics, a developer of a technology for the rapid assessment of kidney function has received additional federal funding to further develop and validate its device technologies.
The company, which is based in the Indiana University Emerging Technologies Center on the IUPUI campus, is using a $1 million Phase II Small Business Technology Transfer grant from the National Institutes of Health for further development and trials of its early detection technology. Grant procurement assistance was provided by the state’s SBIR/STTR office. FAST Diagnostics is also a 2008 recipient of a $2 million grant from the state’s 21st Century Research and Technology Fund.
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