Company Core Data Sheets &
Core Safety Information
Overview
- 2-Day seminar
- For pharmaceutical company employees; admission of other attendees only on invitation by Pharmiceutics LLC
Target Audience
- Labeling/regulatory professionals
- Pharmacovigilance professionals
- Clinical/medical professionals
- Law department members
- For those new to core labeling and for experienced professionals who seek discussion with peers and the instructor about particular challenges and newest trends
Brief Program Outline
The following outline is a sample only and the actual seminar may differ.
View Seminar Details
Click the following links to get to a detailed description of seminar content. Note: The structure of an individual seminar may deviate from the structure of these Seminar Details
- The CCDS as a Corporate Labeling Control Tool
- Company Core Safety Information: Recommendations of the CIOMS Working Groups and Current Regulatory Expectations – An Overview
- Alerting Users About Risks - General Considerations
- Populating the Adverse Reactions Section of a CCDS/CCSI
- Populating the Interactions Section of a CCDS/CCSI - Handling of Information on Drug-Laboratory Test Interference
- How Labeling Supports the Process of Selecting the Right Medicine for the Right Patient/Consumer
- Populating the Indications and Contraindications Sections of a CCDS/CCSI
- Populating the Warnings and Precautions Section of a CCDS/CCSI – Placement of Information on Use in Specific Populations
- Other Sections, Other Aspects
- Core Labeling and Controlled Terminology
- Supporting Rationales and Documentation for Safety Updates
- Regulatory Considerations and Strategies
- Development Core Safety Information and Development Core Data Sheets
Seminar History and Changes to the Seminar Structure
Over the last 4 years, our “Core Labeling Practices” seminar has become THE core labeling course and training event for regulatory/labeling, pharmacovigilance and clinical professionals. It has been held numerous times as a public seminar and as an in-house event for large pharmaceutical companies. Throughout this time, feedback from attendees and the rapid developments in the global labeling/regulatory environment led to continuous updates of the curriculum.
Since July 2007, this seminar is offered under the name: “Company Core Data Sheets and Core Safety Information.”
Effective February 2008, the structure and curriculum has been revised to include a more detailed review of CIOMS recommendations vis-à-vis actual labeling regulations, and to provide a more systematic coverage of typical CCDS sections. This structure makes the seminar binder a better-organized "reference book for core labeling.”
In addition, we eliminated prescheduled break-out group work from the agenda. Case studies for group exercises are still available and can be used if time permits and the participants wish to do them. The purpose of case studies is to stimulate discussion and exchange among participants. The mix of participants with different backgrounds (labeling, pharmacovigilance, regulatory, medical, etc.) fosters interaction so much so that the participants often decide to drop the case studies in favor of whole-group discussions.
In February 2009, we began offering a new, additional 2-day seminar: "Safety Labeling - In-depth Review of Important Aspects". Responding to requests from industry professionals, it offers a very detailed discussion of selected critical aspects of safety labeling, and includes several practice exercises.