FDAnews Announces — Medical Devices and the FDA Reauthorization Act of 2017: What YOU Need to Know about FDARA Webinar, July 26, 2018
FALLS CHURCH, Va. (PRWEB) July 13, 2018 -- Medical Devices and the FDA Reauthorization Act of 2017:
What YOU Need to Know about FDARA
**An FDAnews Webinar**
July 26, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/mdfdareauthorizationact
Regulatory changes aren’t always a good thing, but many devicemakers are looking forward eagerly to the day FDARA, the FDA Reauthorization Act of 2017, takes effect.
Several FDARA deadlines fall next month. While the new law is viewed as generally easing burden on the device community, the devil is in the details.
A noted FDA regulatory lawyer takes devicemakers through the new law step-by-step. Over 90 fast-paced minutes, Jessica Ringel Esq. of King & Spalding LLP will touch on:
• User fees: Changes devicemakers can expect in the fees they pay for premarket submissions
• FDA Inspections: Improvements anticipated in the inspections process
• Certificates to Foreign Governments: How transparency in issuance and denials will increase
• Pediatric device development: Specific FDA efforts to stimulate innovation in this area
• What’s to come: New guidances, rules and reports anticipated from the agency in coming years
• And much more
Even in the absence of formal FDA policy or rule changes, knowing FDARA’s requirements and understanding twists and turns in FDA policy will benefit every FDA-regulated devicemaker.
Meet the Presenter:
Jessica Ringel Esq. is Counsel in the Washington offices of King & Spalding LLP where she participates in the FDA and Life Sciences practice. She is an expert on post-market inspections, responses to Forms 483s and Warning Letters, recalls and other enforcement actions. She regularly conducts due diligence reviews for drug and device manufacturers, private equity firms, and lenders in connection with mergers, acquisitions, investments, and other financial transactions.
Who Will Benefit:
Devicemakers, contract manufacturers, device specification develops and others subject to FDA device inspection, including specific job titles such as:
• Quality personnel
• Operations personnel
• Regulatory personnel
• Compliance personnel
• Legal counsel
Webinar Details:
Medical Devices and the FDA Reauthorization Act of 2017:
What YOU Need to Know about FDARA
**An FDAnews Webinar**
July 26, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/mdfdareauthorizationact
Tuition:
$287 per site
Easy Ways to Register:
Online: http://www.fdanews.com/mdfdareauthorizationact
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.
Michelle Butler, FDAnews, http://www.fdanews.com, +1 703-538-7660, [email protected]
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