Life Sciences Horizons Brochure 2025 - Flipbook - Page 81
2025 Horizons Life Sciences and Health Care
Cross-Jurisdictional.
80
10
Click on a section to take you to the relevant page
81
The hospital as a global institution
82
EU MDR/IVDR and U.S. FDA harmonization
& global regulatory alignment
84
Complex patchwork of rules govern GMO
medicine trials in the EU
91
How global antitrust compliance programs
may help pharmaceutical companies
92
How medical device companies should
navigate the evolving AI regulatory landscape
94
FDA transition to QMSR marks a new era in
device compliance
95
It was only a gift: Identifying and mitigating
compliance risks
96
Use of AI in compliance and investigations:
Expectations from regulators and enforcement
agencies
97
“How do I terminate this agreement?”: Top tips
for terminating an agreement to achieve an
optimal outcome in any subsequent dispute