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FALLS CHURCH, Va., Oct. 26, 2018 /PRNewswire-PRWeb/ -- FDAnews has called on top medical device regulation experts, Suzan Onel and Will Woodlee, partners at Kleinfeld, Kaplan & Becker LLP, to guide manufacturers through the regulatory, quality and legal maze of medical device regulation and quality. It's a day packed full of panel discussions on topics from emerging policies to strategies for working with the FDA.
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
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 themselves in the current regulatory climate and prepare for what lies down the road.
Here's just a sampling of what the event will cover:
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:
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.
SOURCE FDANEWS
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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
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 themselves 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
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
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.
SOURCE FDANEWS
