Welcome!

News Feed Item

FDA Approval Process for Medical Devices - Updated Programme Includes all the Current FDA Guidelines (Seminar, London)

DUBLIN, April 10, 2014 /PRNewswire/ --

Research and Markets (http://www.researchandmarkets.com/research/t45c8d/fda_approval) has announced the addition of the "FDA Approval Process for Medical Devices - Updated Programme Includes all the Current FDA Guidelines (Seminar, London)"conference to their offering. 

     (Photo: http://photos.prnewswire.com/prnh/20130307/600769 )

The FDA Approval Process for Medical Devices seminar will take place on the 19th & 20th May 2014 at The Rembrandt Hotel, London

This seminar will highlight new changes in the medical device regulations and provide an overview of the submission of documents to the FDA for approval of medical device products. Participants will gain a better understanding of the medical device approval process and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research will be provided, as well as information on the structuring of submissions and post-approval documents. Information on maintaining ongoing relationships with the FDA will also be discussed. Attendance at this seminar will enable delegates to provide the FDA with the necessary information to obtain product approval.

Upon completion of this seminar, participants will:

- Understand the FDA medical device approval system

- Know what is required for an Investigational Device Exemption (IDE)

- Learn the contents of a Post-Market Approval (PMA)

- Discover what to include in an annual report

WHO SHOULD ATTEND

This seminar is intended for Regulatory, Technical and Quality Personnel who require an understanding of the FDA medical device approval system. Management, Legal and other personnel who must be familiar with the essentials of the medical device approval process and submission of related documents will also benefit in attending.

DOCUMENTATION

Delegates will receive a course material folder containing comprehensive documentation provided by the speaker, which will be a valuable source of reference for the future.

A Certificate of Attendance for Professional Development will be given to each participant who completes each course

DATES:

19 & 20 May 2014 

TIMES:

19 May 2014 Start 09.30 - Finish 17.00
20 May 2014 Start 09.00 - Finish 16.30

REGISTRATION & COFFEE

19 May 2014 09.00

VENUE & ACCOMMODATION

The Rembrandt Hotel, 11 Thurloe Place, London SW7 2RS

DIRECTIONS:

Opposite V&A Museum. Nearest underground station: South Kensington.

NOTE: Events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged 

Key Topics Covered: 

PROGRAMME DAY ONE - 19 May 2014 

Introduction to FDA

- History and law
- Definitions
- Overview of FDA
- Establishment registration
- Product licensing


510(k) Process

- Substantial equivalence
- Letter of notification
- Truthful and accurate statements
- Cover page
- Table of contents
- Checklist for filing
- Executive summary
- Intended use
- Device description
- Table of comparison
- Similarities and differences
- Environmental testing
- Comparative performance
- Clinical performance
- Software
- Biocompatibility
- Voluntary standards
- Sterility
- Reusable or single-use device control
- Labelling
- Kit information
- 510(k) summary
- FDA 510(k) review

PROGRAMME DAY TWO - 20 May 2014

Investigational Device Exemption (IDE)

- Significant risk versus non-significant risk
- Sponsor
- Prior investigations and investigational plan
- Facilities and controls
- Investigator agreement
- IRB
- Institutions
- Sale of device
- Environmental assessment
- Labelling
- Informed consent
- GCP
- FDA actions on applications



Pre-Market Approval (PMA)

- Applicant
- Table of contents and summary
- Device description
- Standards
- Non-clinical studies and clinical studies
- One investigator
- Bibliography
- Samples
- Labelling
- Environmental assessment
- PMA amendments and PMA supplements
- FDA action on PMA
- Post-approval requirements 


Speakers

Albert. A Ghignone, MS, RAC, FDA Regulatory, Quality and Clinical Consultant, AAG Incorporated, USA. He has spent more than 30 years in the pharmaceutical industry at Sterling Drugs, Carter-Wallace, Hoechst-Roussel, National Patient Development Corporation and Datascope Corporation. He has a background in pharmacy and dosage form development. 

His professional career has specifically focused in the areas ofregulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics and medical devices. In his various positions he was responsible for all regulatory submissions, registrations, FDA liaison and all compliance activities. He also has expertise in the assessment of product and facilities for the due diligence relative to FDA requirements. He lectures throughout the world on drugs, biologics, medical devices and FDA related matters. 

He is a member of the Regulatory Affairs Professional Society, which gave him the Professional of the Year award in 1984. He has served the society as Vice-President, President and Chairman of the Board of Directors. He is certified as both an ISO 9000 Lead Auditor and Regulatory Affairs Professional.

NOTE: Events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged

For more information visit http://www.researchandmarkets.com/research/t45c8d/fda_approval

About Research and Markets

Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Media Contact: Laura Wood , +353-1-481-1716, [email protected]

SOURCE Research and Markets

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Recently, REAN Cloud built a digital concierge for a North Carolina hospital that had observed that most patient call button questions were repetitive. In addition, the paper-based process used to measure patient health metrics was laborious, not in real-time and sometimes error-prone. In their session at 21st Cloud Expo, Sean Finnerty, Executive Director, Practice Lead, Health Care & Life Science at REAN Cloud, and Dr. S.P.T. Krishnan, Principal Architect at REAN Cloud, discussed how they built...
Sanjeev Sharma Joins June 5-7, 2018 @DevOpsSummit at @Cloud Expo New York Faculty. Sanjeev Sharma is an internationally known DevOps and Cloud Transformation thought leader, technology executive, and author. Sanjeev's industry experience includes tenures as CTO, Technical Sales leader, and Cloud Architect leader. As an IBM Distinguished Engineer, Sanjeev is recognized at the highest levels of IBM's core of technical leaders.
Nordstrom is transforming the way that they do business and the cloud is the key to enabling speed and hyper personalized customer experiences. In his session at 21st Cloud Expo, Ken Schow, VP of Engineering at Nordstrom, discussed some of the key learnings and common pitfalls of large enterprises moving to the cloud. This includes strategies around choosing a cloud provider(s), architecture, and lessons learned. In addition, he covered some of the best practices for structured team migration an...
Digital transformation is about embracing digital technologies into a company's culture to better connect with its customers, automate processes, create better tools, enter new markets, etc. Such a transformation requires continuous orchestration across teams and an environment based on open collaboration and daily experiments. In his session at 21st Cloud Expo, Alex Casalboni, Technical (Cloud) Evangelist at Cloud Academy, explored and discussed the most urgent unsolved challenges to achieve f...
Recently, WebRTC has a lot of eyes from market. The use cases of WebRTC are expanding - video chat, online education, online health care etc. Not only for human-to-human communication, but also IoT use cases such as machine to human use cases can be seen recently. One of the typical use-case is remote camera monitoring. With WebRTC, people can have interoperability and flexibility for deploying monitoring service. However, the benefit of WebRTC for IoT is not only its convenience and interopera...
SYS-CON Events announced today that Synametrics Technologies will exhibit at SYS-CON's 22nd International Cloud Expo®, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. Synametrics Technologies is a privately held company based in Plainsboro, New Jersey that has been providing solutions for the developer community since 1997. Based on the success of its initial product offerings such as WinSQL, Xeams, SynaMan and Syncrify, Synametrics continues to create and hone inn...
"WineSOFT is a software company making proxy server software, which is widely used in the telecommunication industry or the content delivery networks or e-commerce," explained Jonathan Ahn, COO of WineSOFT, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
The past few years have brought a sea change in the way applications are architected, developed, and consumed—increasing both the complexity of testing and the business impact of software failures. How can software testing professionals keep pace with modern application delivery, given the trends that impact both architectures (cloud, microservices, and APIs) and processes (DevOps, agile, and continuous delivery)? This is where continuous testing comes in. D
The dynamic nature of the cloud means that change is a constant when it comes to modern cloud-based infrastructure. Delivering modern applications to end users, therefore, is a constantly shifting challenge. Delivery automation helps IT Ops teams ensure that apps are providing an optimal end user experience over hybrid-cloud and multi-cloud environments, no matter what the current state of the infrastructure is. To employ a delivery automation strategy that reflects your business rules, making r...
There is a huge demand for responsive, real-time mobile and web experiences, but current architectural patterns do not easily accommodate applications that respond to events in real time. Common solutions using message queues or HTTP long-polling quickly lead to resiliency, scalability and development velocity challenges. In his session at 21st Cloud Expo, Ryland Degnan, a Senior Software Engineer on the Netflix Edge Platform team, will discuss how by leveraging a reactive stream-based protocol,...
Modern software design has fundamentally changed how we manage applications, causing many to turn to containers as the new virtual machine for resource management. As container adoption grows beyond stateless applications to stateful workloads, the need for persistent storage is foundational - something customers routinely cite as a top pain point. In his session at @DevOpsSummit at 21st Cloud Expo, Bill Borsari, Head of Systems Engineering at Datera, explored how organizations can reap the bene...
Most technology leaders, contemporary and from the hardware era, are reshaping their businesses to do software. They hope to capture value from emerging technologies such as IoT, SDN, and AI. Ultimately, irrespective of the vertical, it is about deriving value from independent software applications participating in an ecosystem as one comprehensive solution. In his session at @ThingsExpo, Kausik Sridhar, founder and CTO of Pulzze Systems, discussed how given the magnitude of today's application ...
Digital Transformation (DX) is not a "one-size-fits all" strategy. Each organization needs to develop its own unique, long-term DX plan. It must do so by realizing that we now live in a data-driven age, and that technologies such as Cloud Computing, Big Data, the IoT, Cognitive Computing, and Blockchain are only tools. In her general session at 21st Cloud Expo, Rebecca Wanta explained how the strategy must focus on DX and include a commitment from top management to create great IT jobs, monitor ...
The 22nd International Cloud Expo | 1st DXWorld Expo has announced that its Call for Papers is open. Cloud Expo | DXWorld Expo, to be held June 5-7, 2018, at the Javits Center in New York, NY, brings together Cloud Computing, Digital Transformation, Big Data, Internet of Things, DevOps, Machine Learning and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding busin...
"Digital transformation - what we knew about it in the past has been redefined. Automation is going to play such a huge role in that because the culture, the technology, and the business operations are being shifted now," stated Brian Boeggeman, VP of Alliances & Partnerships at Ayehu, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.