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[h2]Course Overview[/h2]
This course provides a detailed review of the legal and regulatory principles driving prescription drug labeling, and patient labeling in the United States, Canada and the European Union. It addresses postmarketing communication to consumers and healthcare professionals, as well as providing an overview of product liability and public health policy issues in the United States. Also covered will be the clinical content structuring and coding based on the SPL Clinical Information Model SPL 2b and its implications on writing labels.
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[h3]Benefits of Attendance[/h3]
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- Gain a basic understanding of the importance of the label in the product lifecycle
- Learn key regulatory principles promulgated by the FDA, EMA and Health Canada
- Identify issues related to advertising
- Network with labeling and regulatory experts
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- Interpret the regulatory principles guiding prescription drug labeling in the US, Canada & EU
- Explain current FDA labeling initiatives such as DailyMed, Structured Product Labeling (SPL), Patient information sheet, Consumer Medication Information (CMI) and principles of medication error prevention
- Summarize the main principles in use and implementation of a Company Core Data Sheet (CCDS)
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[tab title=”Key Topics”]
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- Prescription Drug Labeling: Content and Format
- Populating the Safety Sections of the USPI
- Development & Implementation of Company Core Data Sheets
- Understanding Labeling Changes from a Liability Perspective
- New Canadian Labeling Guidelines
- EU SmPC Guideline
- FDA Office of Drug Safety and Medication Errors
- Communicating with Patients: Labeling and Advertising
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[tab title=”Who Should Attend”]
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- Regulatory and Clinical Managers
- Drug Information Specialists
- Senior Research & Development Professionals
- Drug Safety Associates
- Project and Marketing Managers
- Medical Affairs Professionals
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REGISTRATION INFORMATION/CONTINUING EDUCATION CREDIT
Course #06C
Continuing Education Credit
Pharmaceutical Education & Research Institute, Inc. (PERI) is pleased to make continuing education credit available to you for attendance at this program. To receive credit, you must attend the entire program and submit the Continuing Education Application form directly to a PERI on-site coordinator.
ACPE Statement:
Pharmaceutical Education & Research Institute, Inc. (PERI) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Activity Number is 0708-0000-13-006-L03-P. 1.4 continuing education units (CEUs) are available for this program. Initial Release Date: 06/17/2013. This is a knowledge based CPE Activity.
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ACCME Statement:
[image src=”/images/cme.jpg” align=”left”] PERI, Inc. is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. PERI, Inc. designates this live activity for a maximum of 14 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
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[h3]Event Details[/h3]
Registration is no longer available for this event.
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[h3]Request a Proposal[/h3]
Interested in bringing this course to your company? Request a proposal and a PERI team member will be in touch about hosting this course as a Corporate Education program.
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[h4]Course Information[/h4]
Marian Selby
Course Manager
703–276-0178, ext. 192
[button_small color=”slate” url=”mailto:mselby@peri.org”]Email Question[/button_small]
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