The U.S. Opioid Crisis - Webinar Recording/Transcript

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The U.S. Opioid Crisis: What Every Regulatory Professional Absolutely, Positively Needs to Know

The opioid crisis is the stuff of daily headlines. But behind the headlines lurk serious implications for drugmakers, healthcare providers and other regulated firms.

But how should a drug firm respond now, before things get out of hand? (Think tobacco settlements.)

Lawyer and author Roseann B. Termini Esq. has answers. In an all-new presentation from FDAnews, Ms. Termini will address these hot-button issues:

  • The likelihood of industry-wide liability similar to the tobacco settlements (if you think that’s not possible, guess again)
  • Concrete measures pharma companies can take now to counter the opioid crisis
  • Opioid deterrents and other novel methods you’ll be called upon to address
  • New regulations that could affect both pharma firms and providers
  • Off-label liability and how to avoid it
  • The opioid task force — how it could affect your operations, including tough new label warnings and dosage limits
  • Developing a proactive plan that integrates both marketing and legal
  • The impact of outside players and stakeholders on FDA regulations and guidances
  • And much more!

The opioid crisis isn’t going away any time soon. Drugmakers and healthcare providers have a lot to lose if public opinion turns against them. Don’t take that risk. Start preparing now.

This presentation targets:

  • Pharmaceutical companies
  • Quality and Regulatory companies
  • Physicians
  • Other medical professionals including PAs, nurses and paramedics
  • Insurers

Within such organizations, job titles include:

  • Regulatory Affairs/Compliance
  • Product Developers
  • QA/QR/QC
  • Risk Managers
  • Product Assurance
  • Enforcement
  • Scientists
  • Sales/Marketing/Strategic Planning

Roseann B. Termini Esq. is an author and educator specializing in direct-to-consumer advertising and corporate accountability. As a lawyer she successfully litigated and prosecuted numerous cases involving food and drug law. As an educator she created online food and drug law courses at Widener University Law School. She was corporate counsel for a pharmaceutical company, founding board member of Pharmaceutical Health Services and is Vice Chair, Health Law Committee. She recently published New Edition Print and E-books — Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary and Tobacco Products (2017)