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6 Must-Knows Before Buying a Drug or Device Company
Manage episode 421183699 series 3506216
المحتوى المقدم من Darshan Kulkarni. يتم تحميل جميع محتويات البودكاست بما في ذلك الحلقات والرسومات وأوصاف البودكاست وتقديمها مباشرة بواسطة Darshan Kulkarni أو شريك منصة البودكاست الخاص بهم. إذا كنت تعتقد أن شخصًا ما يستخدم عملك المحمي بحقوق الطبع والنشر دون إذنك، فيمكنك اتباع العملية الموضحة هنا https://ar.player.fm/legal.
Buying a Drug or Device Company? 6 Compliance Must-Knows
Thinking of acquiring a drug or device company? Buckle up! This deal requires serious compliance considerations. Here's a quick rundown:
The DOJ offers a 6-month "safe harbor" for confessing past compliance issues. Use it!
The DOJ demands strong compliance programs with thorough risk assessments, effective training, and clear reporting channels.
Companies can now claw back bonuses from employees who break compliance rules.
Accurate risk assessments, comprehensive training, and clear misconduct reporting are key for HHS compliance.
Disclosing payments to doctors and hospitals is crucial too, with details readily available online.
Don't forget about mandatory clinical trial disclosures on ClinicalTrials.gov. Skipping this can lead to hefty fines and hinder future research.
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