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
In his session at 19th Cloud Expo, Claude Remillard, Principal Program Manager in Developer Division at Microsoft, contrasted how his team used config as code and immutable patterns for continuous delivery of microservices and apps to the cloud. He showed how the immutable patterns helps developers do away with most of the complexity of config as code-enabling scenarios such as rollback, zero downtime upgrades with far greater simplicity. He also demoed building immutable pipelines in the cloud ...
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Choosing the right cloud for your workloads is a balancing act that can cost your organization time, money and aggravation - unless you get it right the first time. Economics, speed, performance, accessibility, administrative needs and security all play a vital role in dictating your approach to the cloud. Without knowing the right questions to ask, you could wind up paying for capacity you'll never need or underestimating the resources required to run your applications.
Technology vendors and analysts are eager to paint a rosy picture of how wonderful IoT is and why your deployment will be great with the use of their products and services. While it is easy to showcase successful IoT solutions, identifying IoT systems that missed the mark or failed can often provide more in the way of key lessons learned. In his session at @ThingsExpo, Peter Vanderminden, Principal Industry Analyst for IoT & Digital Supply Chain to Flatiron Strategies, will focus on how IoT depl...
Adding public cloud resources to an existing application can be a daunting process. The tools that you currently use to manage the software and hardware outside the cloud aren’t always the best tools to efficiently grow into the cloud. All of the major configuration management tools have cloud orchestration plugins that can be leveraged, but there are also cloud-native tools that can dramatically improve the efficiency of managing your application lifecycle. In his session at 18th Cloud Expo, ...
The pace of innovation, vendor lock-in, production sustainability, cost-effectiveness, and managing risk… In his session at 18th Cloud Expo, Dan Choquette, Founder of RackN, discussed how CIOs are challenged finding the balance of finding the right tools, technology and operational model that serves the business the best. He also discussed how clouds, open source software and infrastructure solutions have benefits but also drawbacks and how workload and operational portability between vendors an...
With the proliferation of both SQL and NoSQL databases, organizations can now target specific fit-for-purpose database tools for their different application needs regarding scalability, ease of use, ACID support, etc. Platform as a Service offerings make this even easier now, enabling developers to roll out their own database infrastructure in minutes with minimal management overhead. However, this same amount of flexibility also comes with the challenges of picking the right tool, on the right ...
Big Data, cloud, analytics, contextual information, wearable tech, sensors, mobility, and WebRTC: together, these advances have created a perfect storm of technologies that are disrupting and transforming classic communications models and ecosystems. In his session at @ThingsExpo, Erik Perotti, Senior Manager of New Ventures on Plantronics’ Innovation team, provided an overview of this technological shift, including associated business and consumer communications impacts, and opportunities it m...
Manufacturers are embracing the Industrial Internet the same way consumers are leveraging Fitbits – to improve overall health and wellness. Both can provide consistent measurement, visibility, and suggest performance improvements customized to help reach goals. Fitbit users can view real-time data and make adjustments to increase their activity. In his session at @ThingsExpo, Mark Bernardo Professional Services Leader, Americas, at GE Digital, discussed how leveraging the Industrial Internet and...
There will be new vendors providing applications, middleware, and connected devices to support the thriving IoT ecosystem. This essentially means that electronic device manufacturers will also be in the software business. Many will be new to building embedded software or robust software. This creates an increased importance on software quality, particularly within the Industrial Internet of Things where business-critical applications are becoming dependent on products controlled by software. Qua...
Fact is, enterprises have significant legacy voice infrastructure that’s costly to replace with pure IP solutions. How can we bring this analog infrastructure into our shiny new cloud applications? There are proven methods to bind both legacy voice applications and traditional PSTN audio into cloud-based applications and services at a carrier scale. Some of the most successful implementations leverage WebRTC, WebSockets, SIP and other open source technologies. In his session at @ThingsExpo, Da...
"Tintri was started in 2008 with the express purpose of building a storage appliance that is ideal for virtualized environments. We support a lot of different hypervisor platforms from VMware to OpenStack to Hyper-V," explained Dan Florea, Director of Product Management at Tintri, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
The speed of software changes in growing and large scale rapid-paced DevOps environments presents a challenge for continuous testing. Many organizations struggle to get this right. Practices that work for small scale continuous testing may not be sufficient as the requirements grow. In his session at DevOps Summit, Marc Hornbeek, Sr. Solutions Architect of DevOps continuous test solutions at Spirent Communications, explained the best practices of continuous testing at high scale, which is rele...
A critical component of any IoT project is what to do with all the data being generated. This data needs to be captured, processed, structured, and stored in a way to facilitate different kinds of queries. Traditional data warehouse and analytical systems are mature technologies that can be used to handle certain kinds of queries, but they are not always well suited to many problems, particularly when there is a need for real-time insights.
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and Containers together help companies to achieve their business goals faster and more effectively. In his session at DevOps Summit, Ruslan Synytsky, CEO and Co-founder of Jelastic, reviewed the current landscape of D...