Standard Operating Procedures ,Title 21,Title 493, 2012 - Live webinar on US Pharmaceutical vs Device Clinical Development: Similarities and Differences Explored By compliance2go

While most clinical research professionals are familiar with US pharmaceutical regulations, many have no experience with regulated research involving medical devices, or their experience is primarily related to studies conducted outside the United States (OUS). As globalization of research increases and more device/drug and device/biologic combination products are introduced into the market, each of us is more likely to become involved in clinical research of medical devices. Device clinical research activities must comply with many of the same regulations as pharmaceutical products, but there are some notable differences. The regulatory similarities and key differences, such as phases of study, classes of risk, adverse experience and reimbursement practices will be presented.

Regulation of medical device approvals in the US differs from that of pharmaceutical products. Many clinical research professionals are not familiar with device research requirements in the US. As more combination products (device/drug, device/biologic) are developed, we will all need to become more familiar with the differences between drug and device research to ensure we are compliant with the regulatory requirements specific to devices.

Why should you Attend:

In the US, clinical development of both devices and drugs are regulated by the FDA. While there are many similarities between regulatory requirements for the two types of products, there are also some important differences.

- List at least three differences between the clinical development and approval of drugs versus devices in the US.

-Identify the US regulations that apply to both drug and device studies.

- Recognize differing product development and product reimbursement practices of drugs and devices.

Areas Covered in the Session:

We will review some key differences between the pharmaceutical and device industries, regulatory requirements common to drug and device clinical studies and illustrate some important differences such as reimbursement issues specific to device trials.

Who will benefit:

- Clinical research manages
- Project managers
- Clinical research associates
- Monitors
- Quality assurance professionals
- Research coordinators
- Clinical investigators

About Speaker

Glenda Guest is Vice President of Norwich Clinical Research Associates Ltd. (NCRA), a full service Clinical Contract Research Organization (CRO) located in central NY State, USA. She has been involved in regulated research since 1997 and specializes in medical device monitoring and project management; GCP, vendor and third party auditing as well as training on US regulated research and Good Clinical Practice.

Ms. Guest is an active member of the Association of Clinical Research Professionals (ACRP) and is a regular speaker at their local events and global conferences. She has also presented at a number of other industry-related events and enjoys sharing her expertise with colleagues in the clinical research arena.

Ms. Guest has maintained her status as an ACRP Certified Clinical Research Associate since April of 2002. She is also recognized by the Society of Quality Assurance as a Registered Quality Assurance Professional - Good Clinical Practices (RQAP-GCP),having successfully passed the first exam for this designation offered by SQA in April 2007.