White Papers

White Papers

Successful Medical Device Development: Critical Factors
Considerations in the Development of Biosimilars
Fundamentals in Drug Safety Strategies
US vs. EU: Differences in Initial Regulatory Applications for Phase 1 Studies
Which Of The European Regulations For Medical Devices Are Going To Be Adapted By The FDA?
Conducting EU Studies from a US Virtual Biotech Company (340.72 KB)
Case Study of Conducting EU Studies from a US Virtual Biotech Company
Preparing for an IND Application (333.22 KB)
The Role of Signal Thresholds (223.76 KB)
How to Recognize the Linkages Between a Safety Event and Drug Use (White Paper)
How to Recognize the Linkages Between a Safety Event and Drug Use (96.03 KB)
Powerpoint presentation
Risk Assessments During Protocol Development (962.78 KB)
Fundamentals in Drug Safety Strategies - Human Factor (1.11 MB)
New Safety Reporting Requirements for Drugs and Biologics: Dissecting the FDAs Sept. 29 Final Rule and Draft Guidance (1.42 MB)
In 90 fast-paced minutes, Joan Antokol, Managing Partner at Park Legal, LLC and Dr. John McLane, COO and VP Clinical and Regulatory Affairs with Clinquest Inc., will analyze the final rule and guidance, advise how to manage individual safety events in various settings, and offer compliance tips for sponsors, CROs and investigators.
Risk Assessments in 510K Clinical Studies (1.08 MB)
Powerpoint presentation
Preparing for an IDE Application (1.29 MB)
Powerpoint presentation