Dr. Lori Alquier | Regulatory Harmonization in a Resource-Limited Setting: The World Health Organization Collaborative Procedure for Accelerated Registration |
Mladen Bozic | The Impact of FDA Patient Focused Drug Development (PFDD) on US Drug Development Strategies: A Survey of Views from Pharmaceutical Product Companies |
Wendy Clark | Patient Focused Recall Strategy and Communication for Implantable Medical Devices: A Survey of the Medical Device Industry Views and Practices |
Kerry Cobb | Surveying Stakeholder Views on the Current Good Laboratory Practices (GLP) Regulations and their Proposed Revisions. |
Wenying Du | China’s Role in Global Drug Development |
Cheryl Hergert | Use of Electronic Health Record Data for Generating Clinical Evidence: A Summary of Medical Device Industry Views |
Ronald Lillie | Implementation of GVP IX for Postmarketing Signal Management in the Bio-Pharmaceutical Industry |
Dr. Hai Luong | Regulatory CMC Strategies for Gene and Cell Therapies During Mergers and Acquisitions: A Survey of Industry Views |
Dr. Lequina Myles | An Industry Survey of Implementation Strategies for Clinical Supply Chain Management of Cell and Gene Therapies |
Nozomi Yagi | US Regulatory Policy for Human Factors Engineering in Medical Devices: A Survey of Policy Impact on Current Practices |