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FALLS CHURCH, Va., Nov. 14, 2018 /PRNewswire-PRWeb/ -- 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
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:
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:
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.
SOURCE FDANEWS
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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:
- The recently changed requirements evolving REMS from a safety initiative to a powerful enforcement tool
- How to protect from enforcement actions and strategies for defending an enforcement
- The most successful strategies to defend against a False Claims Act case based on compliance with safety requirements
- Recent settlements and what they mean
- Novo Nordisk — resulted in disgorgement of $12 million, and payment of $46.5 million to resolve False Claims Act liability
- Aegerion — contained both criminal and civil components and resulted in the company agreeing to pay $7.2 million in criminal fines and forfeiture
- How to prevent a Deferred Prosecution Agreement with the government to resolve charges of conspiracy to violate HIPAA
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:
- Regulatory Affairs
- Quality Assurance
- Regulatory Counsel
- Contractors
- Consultants
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.
SOURCE FDANEWS
