Broadcast Date: Wednesday, May 24, 2023
from 12:00 pm to 1:00 pm (ET)
Overview:
FDA’s enforcement landscape continues to evolve as the agency implements its new legislative authorities, advances its regulation of cutting-edge issues, addresses significant supply chain concerns, and deals with the fallout from the COVID-19 public health emergency. Despite the evolving landscape, enforcement related to manufacturing and data integrity-related deficiencies and unapproved new products remain at the core of the agency’s enforcement priorities.
In this LIVE Webcast, attorneys from Ropes & Gray will provide the audience with an in-depth analysis of the latest trends and issues shaping the food and drug industry today. Speakers will discuss key FDA initiatives and offer best practices to help industry stakeholders successfully navigate this evolving legal climate, mitigate compliance risks, and maximize potential opportunities.
Key topics include:
- Key Legislative Developments
- FDA Enforcement Priorities
- Compliance Best Practices
Credit:
Course Level:
Intermediate
Advance Preparation:
Print and review course materials
Method of Presentation:
On-Demand Webcast
Prerequisite:
General knowledge of food and drug regulations
Course Code:
1410771
NY Category of CLE Credit:
Areas of Professional Practice
Total Credit:
1.0 CLE
How to Claim CLE Credits Per State:
https://knowledgewebcasts.com/how-to-claim-cle-credits-per-state/
CLE State Requirements:
https://knowledgewebcasts.com/cle-state-requirements/
CPE State Requirements:
Speaker Panel:
Joshua Oyster, Partner
Experienced Life Sciences Regulatory Attorney
Ropes & Gray LLP
Josh Oyster is a partner in Ropes & Gray’s Life Sciences Regulatory & Compliance practice. He steers clients through a wide range of FDA regulatory issues to help them bring innovative products to market while also ensuring regulatory compliance. Josh is regularly called upon for help with a range of enforcement, regulatory compliance and transactional matters. Josh routinely helps companies navigate FDA inspections, Warning Letters, product recalls, and other compliance and enforcement matters. He is frequently tapped to analyze clients’ toughest questions related to complex or ambiguous regulatory requirements, drawing on his extensive experience with key policy and enforcement priorities, including medical product promotion, digital health, drug compounding, data integrity, CBD, and developments arising from the COVID-19 pandemic. In addition, Josh assists clients in assessing regulatory risks associated with potential acquisitions and investments in FDA-regulated entities.
Rebecca H. Williams, Associate
Ropes & Gray LLP
Rebecca focuses her practice on FDA regulatory matters and advises life sciences and health care clients on a broad range of regulatory and compliance issues under the Food, Drug and Cosmetics Act and related laws. Rebecca routinely provides regulatory counsel for corporate transactions, license and collaboration agreements, manufacturing and supply arrangements, and public and private securities offerings involving drug, device, cosmetic, food, and dietary supplement companies. Rebecca also regularly provides legal and strategic advice to pharmaceutical and biotech clients on advertising and promotion issues. Rebecca maintains an active pro bono practice with a focus on immigration, health care, and child welfare issues.
Agenda:
Joshua Oyster, Partner
Ropes & Gray LLP
AND
Rebecca H. Williams, Associate
Ropes & Gray LLP
- Key Legislative Developments
- FDA Enforcement Priorities
- Compliance Best Practices
Date & Time:
Wednesday, May 24, 2023
12:00 pm to 1:00 pm (ET)
Who Should Attend:
- FDA Attorneys
- FDA Specialists
- FDA Inspectors
- Operations Executives
- Compliance Executives and Officers
- Regulatory Executives and Officers
- General Counsel from Food/Drug/Beverage Industries
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