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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.