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:4/12/2019)... ... April 11, 2019 , ... Neal O’Farrell is one of the ... experience. He is executive director of the consumer advocacy non-profit the Identity Theft Council ... a member of the Federal Communications Commission’s Cybersecurity Roundtable and is currently a fellow ...
(Date:4/9/2019)... ... 2019 , ... The McLeod Center for Cancer Treatment and Research ... voluntary audit conducted by an independent, third-party panel of experts in radiation oncology, patient ... United States, McLeod is the only such cancer center in South Carolina. The hospital ...
(Date:4/4/2019)... ... April 02, 2019 , ... The ... will provide insight into the connectivity between product risk management (ISO 14971) and ... in supporting this process. , With increasing global regulation and reimbursement challenges faced ...
Breaking Biology News(10 mins):
(Date:3/19/2019)... ... March 19, 2019 , ... ... (Konica Minolta) today announced the formation of their inaugural Scientific Advisory Board. ... precision medicine that takes into account individual variability in genes, environment, and lifestyle ...
(Date:3/18/2019)... ... March 18, 2019 , ... For more than 15 years, USDM Life ... life science companies to easily comply with FDA 21 CFR Part 11 and EMA ... managed service delivering end-to-end GxP compliance from vendor audit through ongoing validation maintenance, including ...
(Date:3/14/2019)... ... March 14, 2019 , ... ... & Expo, themed “Navigating the Full Spectrum of Case Management,” continues as CMSA ... 2019. This conference is the only case management industry conference serving the educational ...
(Date:3/14/2019)... ... March 14, 2019 , ... ... a preclinical gold standard solution for preclinical research organizations. It is a ... end-to-end workflows, connected systems and facilities, innovative technology-driven automated data capture and ...
Breaking Biology Technology: