With the increasing difficulties in internally-generated product development, drug, biologics, and device firms of all sizes are looking to acquisitions to augment product lines. Whether in the form of single products or whole companies, transactions can make or break the future of a company. However, often lost in the frenzy of a deal involving highly-regulated biomedical companies or products is the critical need to ensure that regulatory, clinical, and quality considerations do not undermine the value or viability of an investment. This webinar will focus on the key regulatory, quality, and clinical issues, including data integrity failings, that must be reviewed when purchasing an FDA-regulated product or company and how to adequately address those concerns in the due diligence phase. The presentation will highlight issues that can undermine a deal altogether or create burdens in the integration phase and how to ensure these issues are properly addressed in advance. The panel will address a “checklist” of items acquiring companies should consider as part of their due diligence, followed by a discussion of specific techniques these companies can use to determine whether due diligence issues exist.
To ensure that FDLI is able to provide you with a seat, materials, and meals, please register for programs at least 48 hours in advance. While onsite registration is available on a “space-available” basis; late registrants are not guaranteed materials or meals.
You can transfer your registration to another person at your organization for no cost by notifying us of the change. If you notify FDLI in writing at least five business days prior to the meeting, you can cancel your registration for a full refund (less a $75 fee). Refunds will be applied against the original form of payment.