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Learn the essential steps of Core Labeling, analyze common problems faced when designing safety information and discussing approaches with internal stakeholders and regulatory authorities, understand the structure and intricacies of US prescribing information (US safety labeling in particular), and define the key features of and performance criteria for a good labeling process – and much more with this new education Certificate Program!
These workshop courses are invaluable for managerial and professional staff in sponsor companies involved in the creation and maintenance of Core Safety Information, SOPs, and prescribing information. This newly-created educational certificate is also designed for labeling professionals at all stages of their careers, and regulatory affairs professionals, pharmacovigilance and medical/clinical professionals, and lawyers who participate in safety decision making, labeling and regulatory implementation.
Upon completion of the required courses, you will have accumulated a comprehensive transcript of knowledge-based courses and workshops to earn the Safety Labeling Certificate.
This new educational certificate is designed for managerial and professional staff in sponsor companies involved in the creation and maintenance of Core Safety Information, SOPs and prescribing information as well as labeling professionals (at all stages of their careers) and professionals involved in regulatory affairs, pharmacovigilance, medical writing and clinical research and design, and lawyers who participate in safety decision making, labeling and regulatory implementation.
[h4]How to Earn the Certificate[/h4]
The workshops required to earn the Safety Labeling Certificate introduce you to the essential steps of Core Labeling, teach you to analyze common problems faced when designing safety information and discussing approaches with internal stakeholders and regulatory authorities. These workshops clearly present the structure and main intricacies of US Prescribing Information and US Safety Labeling in particular while defining the key features of, and performance criteria for, a good labeling process. Upon completion of the required courses, you will have accumulated a comprehensive transcript of knowledge-based courses and workshops to earn the certificate.
To complete this program, you must register for and attend four of the following courses:
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- Company Core Data Sheets & Core Safety Information
- Safety Labeling: In Depth Review of Important Aspects
- US Prescribing Information and Safety Labeling
- Global Labeling Process Design and Evaluation
- Prescription Drug Labeling Regulations
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[h3]Ready to Start?[/h3]
Apply in just two minutes or start searching for courses immediately.
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[h4]Current Students: Track Progress[/h4]Submit your basic contact information to receive a progress update.
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