Clinical Due Diligence: Evaluating and Acquiring Clinical Trials in Medical Devices
| Date: March 17, 2010 |
| Time: 12:00 pm - 1:30 pm Eastern Time US; Please check your time zone prior to the webinar |
| Registration Deadline: March 16, 2010, 11:59 pm Eastern Time |
Contact Hours: CME, CBRN, ACRP
Earn 1.5 contact hours (only purchaser eligible to receive contact hours) |
| Level: Intermediate |
| Member Rate: $99.00 |
| Regular Rate: $124.00 |
|
|
Program Description
- Describe the importance of clinical due diligence
- Regulatory implications: corporate warning letters
- Know what the company is acquiring: get your money's worth
- Pre-Acquisition Diligence
- What one needs to see
- What one needs to do
- Cautionary tales: what happens when you don't
- Post-Acquisition/Partnership
- What are the implications
- What is required
- More cautionary tales: what happens when you don't
- How Can a Company Avoid the Mistakes?
- From both sides of the contract
Target Audience
This webinar is intended for any clinical, medical and regulatory persons involved with clinical due diligence, and those professionals also with companies that have trials in medical devices that might be examined by other companies.
Learning Objectives
Upon completion of this webinar, attendees should be able to:
- Demonstrate a knowledge of the implications of clinical due diligence
- Distinguish between the pre- and post-acquisition demands
- Compare the needs of both large and small companies in clinical work prior to a merger/acquisition
Presenters
Robert S. Walsh, MD, MBA, FAHA, FCCP is a Medical Director for Boston Scientific Corporation. He is a cardiothoracic surgeon who had been in academia and private practice for 12 years prior to joining industry. He works with the Endoscopy, Urology/Womens Health and Electrophysiology divisions of Boston Scientific.
Dr. Walsh states that he is an employee of Boston Scientific Corporation, Inc.
Heidi Hershberger, BS, AS, is a Director for the Strategic Partnerships of Boston Scientific Clinical Sciences. Heidi has over twenty years of experience in Project Management in the healthcare and consumer goods industries. She has worked within the clinical research setting on a variety of medical device and pharmaceutical projects ranging from feasibility to pivotal trials. Heidi currently oversees the conduct of clinical due diligence assessments and integration of potential Boston Scientific Corporation partners across all therapeutic divisions.
Ms. Hershberger states that she has no actual or potential financial conflict of interest in relation to this program.
Accreditation Information
Continuing Nursing Education
The California Board of Registered Nursing approves the Association of Clinical Research Professionals (ACRP) as a provider of continuing nursing education. ACRP’s webinar program provides 1.5 contact hours of continuing nursing education credit (Program Number 11147-2010-307).
Accreditation Council for Continuing Medical Education
The Association of Clinical Research Professionals (ACRP) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
The Association of Clinical Research Professionals designates this educational activity for a maximum of 1.5 AMA PRA Category 1 credits™. Each physician should only claim credit commensurate with the extent of their participation in the activity (Program Number 0007229-2010-CME-307).
Association of Clinical Research Professionals
The Association of Clinical Research Professionals (ACRP) provides 1.5 continuing education credits for the completion of this educational activity with the completion of the online evaluation form. These credits can be used to meet the certification maintenance requirement (Program Number ACRP-2010-WEB-307).
Please note: Webinar presentations are delivered online at the scheduled presentation time only and will not be distributed prior to or following the event. Speakers maintain all copyrights on presentation materials and duplication or preservation of webinar content is strictly prohibited.