DIA 2018 Global Annual Meeting
The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.
Modernization and Harmonization of Inspectional Approaches
Stephen Mahoney, JD, MS
- Senior Director, Compliance and External Collaboration, Pharma Technical Quality
- Genentech, A Member of the Roche Group, United States
This session will discuss industry challenges, needs and feedback regarding international efforts currently underway to harmonize global inspection schemes.
Learning Objective : The forum will discuss the need to engage FDA in reforming its compliance and enforcement process.
Moving Beyond Compliance
- Global Vice President, Head External Relations
- Novartis Pharmaceuticals Corporation, United States
Reforming FDA's Enforcement Process
Howard Sklamberg, JD, MA
- Partner, Health Group
- Akin Gump Strauss Hauer & Feld LLP, United States
International Inspections Issues and Successful Remediation
Thomas J. Cosgrove, JD
- Covington & Burling LLP, United States