The Information Professional’s Role in Product Safety. Jack Leitmeyer Director, Adverse Experience Information Management Worldwide Product Safety Merck & Co., Inc. Agenda. Importance of Safety Surveillance Regulatory Requirements
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Director, Adverse Experience Information Management
Worldwide Product Safety
Merck & Co., Inc.
Pre-Approval - To IND
Post-Approval - To IND
Post-Approval - To NDA
Pre-Approval - Termination of IND
21 CFR 312.44
Phase 1, 2 or 3
(b)(1)(vii) “The sponsor fails promptly to investigate and inform the Food and Drug Administration and all investigators of serious and unexpected adverse experiences in accordance with part 312 section 32 or fails to make any other report required under this part.”
Post-Approval- Withdrawal of NDA
21 CFR 314.80 (K)
“If an applicant fails to establish and maintain records and make reports required under this section FDA may withdraw approval of the application and, thus, prohibit continued marketing of the drug product that is the subject of the application.”
Reports / Queries
Data Mining Applications
Regulatory Submission database
Clinical (MedDRA) / Drug Dictionaries
Clinical Risk Mgt.
Clinical Trial data
MedDRA® is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).