Inside the Minds provides readers with proven business intelligence from C-Level executives and lawyers (Chairman, CEO, CFO, CMO, Partner) from the world's most respected companies and firms nationwide. Each chapter is comparable to an essay/thought leadership piece and is a future-oriented look at where an industry, profession, or topic is heading and the most important issues for the future. Each author has been selected based upon their experience and C-level standing within the professional community.
Chapters Include: 1. Mitchell Fuerst and Christine Humphrey, Partners, Fuerst Humphrey Ittleman PL - "Assisting and Defending Clients in Overcoming Violations and Resolving Compliance Situations"
2. Christopher L. Hagenbush, Partner, Patton Boggs LLP Compliance Issues and Challenges for Food and Drug Industry Clients
3. Mark C. Levy, Partner, Saul Ewing LLP - "Defending a Pharmaceutical, Medical Device, or Biotechnology Client in a Government Investigation: Key Issues for Clients and Attorneys"
4. Heather E.A. Watts, Partner, Deeth Williams Wall LLP - "Canadian Food and Drug Law Enforcement Trends and Issues"
5. Claudia Lewis-Eng, Partner, Venable LLP - "Working Amicably with the FDA"
Appendices Include:
Appendix A: Summary of Laws Enforced by the FDA
Appendix B: FDA Guide to Self-Inspection
Appendix C: FDA Compliance Program Guidance Manual Information
Appendix D: FDA Issues Good Reprint Practices Guidance
