Navigation Links
FDAnews Announces — Early Bird Pricing Ends on Nov. 8 for Emerging Trends in Medical Device Regulation and Quality, Dec. 6, 2018, Washington, DC
Date:11/3/2018

Emerging Trends in Medical Device Regulation and Quality:
New Regulations, New Guidance, New Challenges and New Opportunities
**Presented by FDAnews**
Dec. 6, 2018 – Kleinfeld, Kaplan & Becker, LLP • Washington, DC
http://www.fdanews.com/trendsmdregquality

Early bird pricing for Emerging Trends in Medical Device Regulation and Quality ends on Thursday, Nov. 8.

Wearable wellness products. Mobile apps. 3D printing. OTC genetic tests. LDTs. Combination products.

Welcome to the fast-paced world of innovative medical devices. It’s a land of emerging trends, FDA regulation and guidance.

What is the best way to navigate the thorny road of innovative medical devices?

It’s time to find out what is ok to do today, tomorrow, and in the weeks and months to follow.

FDAnews has called on a top medical device regulation experts, Suzan Onel and Will Woodlee, partners at Kleinfeld, Kaplan & Becker LLP, to guide devicemakers through the regulatory, quality and legal maze. It’s a day packed full of panel discussions on topics from emerging policies to strategies for working with the FDA. And there’s no need to travel — the whole event is livestreamed.

Attendees will end the day fully briefed on how to comport themselve in the current regulatory climate and prepare for what lies down the road.

Here’s just a sampling of what the event will cover:

  • Emerging FDA policies — wearable wellness products, 3D printing, OTC genetic tests, lab developed tests (LDTs), and combination products
  • Current trends in enforcement
  • The requirements for disclosure of medical device clinical trial information on ClinicalTrials.gov
  • How the FDA’s regulations on the use of OUS data in premarket submissions have changed
  • How the reorganization of CDRH, ORA, and ODE could affect the development and approval of medical devices
  • Legislative initiatives that may impact medical devices
  • Strategies for interacting with FDA and managing risk
  • Real world, practical insight on making premarket submission decisions and whether to prepare a Letter to File (LTF) or file a 510(k), De Novo, or PMA submission
  • And much more

Stay abreast of emerging trends and developments in the dynamic world of innovative medical devices. This groundbreaking livestream event provides an overview of recent regulatory, compliance, policy, and legislative developments and offers practical insight into regulatory and quality issues.

Early bird pricing ends on Thursday, Nov. 8.

Meet the Chairpersons:
Suzan Onel, Partner at Kleinfeld, Kaplan & Becker in Washington, DC.
Suzan Onel, J.D. joined Kleinfeld, Kaplan & Becker (KKB) in 2016. Prior to joining KKB in 2016, Ms. Onel was Chair of the FDA Practice at a global law firm. Suzan is a recognized expert in FDA law. She has advised medical device, pharmaceutical, food, supplement, and cosmetic clients on FDA-related legal and regulatory issues since 1990.

Will Woodlee, Partner at Kleinfeld, Kaplan & Becker in Washington, DC.
Will Woodlee joined Kleinfeld, Kaplan & Becker in 2010. Will’s practice focuses primarily on counseling and advocating on behalf of food, dietary supplement, cosmetic, pharmaceutical, medical device, tobacco, and consumer product companies on regulatory and advertising law matters.

Who Will Benefit:

  • Regulatory specialists
  • Quality specialists
  • Attorneys
  • Managers/Directors
  • Consultants
  • Strategic planners
  • Clinical trial developers
  • Data specialists

Conference Details:
Emerging Trends in Medical Device Regulation and Quality:
New Regulations, New Guidance, New Challenges and New Opportunities
**Presented by FDAnews**
Dec. 6, 2018 – Kleinfeld, Kaplan & Becker, LLP • Washington, DC
http://www.fdanews.com/trendsmdregquality

Tuition:
Early Bird Pricing: $597 (available until Nov. 8, 2018)
Regular Pricing: $697 (after Nov. 8, 2018)
Significant team discounts are available.

Easy Ways to Register:
Online: http://www.fdanews.com/trendsmdregquality
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Read the full story at https://www.prweb.com/releases/fdanews_announces_early_bird_pricing_ends_on_nov_8_for_emerging_trends_in_medical_device_regulation_and_quality_dec_6_2018_washington_dc/prweb15884153.htm.


'/>"/>
Source: PRWeb
Copyright©2018 Vocus, Inc.
All rights reserved


Related biology news :

1. Karius Announces the Clinical Investigator Award for Applied Pediatric Infectious Disease Genomics
2. Myoscience Announces Commercial Release of Nerve Stim Enabled iovera° Smart Tip
3. Slone Partners, Where People Are Our Science®, Announces Insights: Scientific Healthcare Investing 2018 Panel Event With Leaders In The Investment Community
4. Ajinomoto Health & Nutrition's Amino Acid Division Announces Price Increase
5. The Arch Mission Foundation Announces Digital Data Stored in DNA Added to Lunar Library™, Creating Groundbreaking Archive of Knowledge on the Moon
6. Fuzionaire Diagnostics Announces Disease-Agnostic Platform to Radiolabel Any Molecule for Disease Diagnosis and Drug Discovery
7. Genedata Announces Aptevo Therapeutics Deploys Genedata Biologics to Streamline Cancer Immunotherapy R&D
8. Diagenode Announces Acquisition of Service Provider NXT-Dx to Complement Epigenetics Assay Services
9. ActiGraph Announces New Scientific Affairs and Data Management Division
10. Trivedi Global, Inc. Announces Research by TC Slade on Energy Treated Vitamin D3 Which Shows Significant Benefits for Bone Health
11. Trivedi Global, Inc. Announces Research by Shirley Holmlund on Energy Treated Vitamin D3 Which Shows Significant Benefits for Bone Health
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/8/2019)... ... May 08, 2019 , ... MMS Holdings – ... services provided by Medrio , the leading provider of eClinical technology for ... , By collaborating to position high-quality CRO services with Medrio’s fast and easy-to-use ...
(Date:5/7/2019)... ... May 07, 2019 , ... Landsec and Spartan Bioscience today ... UK. , In May, Landsec will undertake trials using Spartan’s innovative Legionella test. ... to take corrective action within hours instead of weeks. This test, if ...
(Date:5/2/2019)... ... April 30, 2019 , ... Global molecular diagnostics company ... Holotype HLA and other Omixon products will be featured in 12 poster presentations ... in Lisbon, Portugal. Among the major scientific events, Omixon’s Lunch Symposium ...
Breaking Biology News(10 mins):
(Date:5/2/2019)... ... April 30, 2019 , ... The centuries old practice ... macro breweries to local craft breweries, and even home brewing clubs scattered across the ... and biological processes, that when mastered can produce a superb product. Students at ...
(Date:4/25/2019)... ... April 23, 2019 , ... Frank is an albino, deaf Great Dane. His owners rescued ... due to his health issues. Despite his hearing impairment, he was always an active and ... would play all day, every day. As the two grew, playtime became rougher and Frank ...
(Date:4/16/2019)... ... April 16, 2019 , ... Fulcrum ... today announced that Bank South Pacific (BSP), the largest regionally owned bank in ... awarded Fulcrum a contract to deliver a fingerprint-based Know Your Customer (KYC) banking ...
(Date:4/10/2019)... ... April 10, 2019 , ... After more than three months of ... kitchen is equipped with updated appliances and modern lighting and fixtures, and will provide ... , “We’ve seen tremendous growth in the demand for our team-building events and ...
Breaking Biology Technology: