1 Supplemental Health Plans Expert Witness Found
Results Sorted Below by State
Debra Leibold, MD, PhD Consultant
Blue Bell, Pennsylvania
Pharmaceutical Regulation, Warnings & Labels
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Pharmaceutical Industry, Drug Development, Product Labeling, Regulatory Labeling, Prescribing Information, Indications, Dosage, Contraindications, Warnings, Precautions, Adverse Experiences, Regulatory Compliance, Safety, FDA, Off-label Use
...Bring decision makers across divisions to the table to negotiate resolution of labeling issues - leading to the creation, revision, and maintenance of clear and compliant product labels that educate health care professionals and patients in the US, EU, Japan, and Rest of World.
Gain consensus and champion proactive consensus-building across Research, Statistics, Regulatory, Joint Ventures, Legal, and Marketing on labeling - laser-focused on the bottom line: “What do the doctor and patient need to know?”
Provide leadership in support of label development for new applications, supplemental applications, revision filings based on new clinical data, new safety information, local labeling, new guideline compliance, and agency comments. Responsible for labeling for headquarter Company Core Data Sheet (CCDS), US (USPI), EU (SmPC), Rest of World, and Japan....
