FALLS CHURCH, Va., Nov. 14, 2018 /PRNewswire-PRWeb/ -- REMS: Requirements, Regulation, and Enforcement: Evolution from
REMS is no longer just a safety requirement. It's now a powerful enforcement tool. A constantly evolving enforcement tool.
In September the FDA added immediate-release opioids to its REMS for opioid analgesics, saying the move will encourage "rational prescribing."
Drug manufacturers need to be prepared for the FDA to add other similar safety requirements in the future.
FDAnews has called on Anne K. Walsh, a Washington, D.C., attorney to discuss why the REMS evolution has occurred and how to prepare for future changes. Her presentation alerts attendees to likely regulatory and legislative changes ahead in coming months, and positions manufacturers for better compliance. Attendees will learn about:
Failure to prepare for REMS changes could result in penalties: civil, and even criminal ones. Don't take that risk.
Meet the Presenter: Anne K. Walsh, Director, Hyman, Phelps & McNamara, P.C., Washington, DC
Anne K. Walsh counsels clients on compliance and enforcement issues, including FDA inspections, seizure and injunction actions, warning letters, and recalls. She focuses on defending companies against allegations of fraud related to marketing and promotion, cGMP and QSR, health care, and clinical studies, with particular emphasis on cases involving joint criminal and civil investigations under the FDCA and the False Claims Act (FCA). She also has successfully sued the government for violating the Administrative Procedure Act (APA). She applies her enforcement expertise to aid companies in compliance efforts, via internal investigations or risk assessment audits.
Who Will Benefit:
Webinar Details: REMS: Requirements, Regulation, and Enforcement: Evolution from Safety Program to Enforcement Tool **An FDAnews Webinar** Nov. 28, 2018 — 1:30 p.m. – 3:00 p.m. ET http://www.fdanews.com/remsrre
Tuition: $287 per site
Easy Ways to Register: Online: http://www.fdanews.com/remsrre 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.
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