April 23: Short Courses
More information coming soon!
April 24-25: Conference
Labeling is a critical tool for the safe and effective use of prescription drugs, biologics, and medical devices. Its purpose is to convey the essential information needed by providers, patients, and payers to make decisions about product access, prescription, and use. Today’s environment of increasingly complex labeling regulations and guidances is especially challenging for products marketed in multiple regions, which demand worldwide consistency of prescribing and patient information. This conference provides a forum for regulators and industry to update their knowledge of local and global labeling-related policies and to examine the impact of changes on regulatory compliance. Through expert panels and interactive discussions, participants will share approaches, processes, and tools to ensure effective labeling that meets regulatory expectations.
- Global Labeling Issues and Updates
- Labeling Role
- Pharmacovigilance Risk Assessment
- Packaging Issues
- Combination Products
- Patient Leaflet
- Plain Language Labeling
- Patient Medication Information (PMI)
- International Strategic Plan
As we prepare our meeting, check out our program from last year here!
Who should attend?
Professionals from biopharmaceutical and device companies, regulatory authorities, CROs, and consulting agencies involved in:
- Clinical Safety/pharmacovigilance
- Regulatory affairs/drug review and approval process
- Medical affairs and communications
- Medical writing
- Clinical research and development
- Product research and development alliances
- Quality control/quality asssurance
At the conclusion of this activity, participants should be able to:
- Discuss new labeling-related developments and regulations (e.g., Canada, EU, Japan, Asia, Latin America, Middle East, Africa, and US)
- Describe the impact of proposed changes to regional and global labeling requirements and implications for labeling practice and processes
- Analyze the impact of current and proposed global and region-specific labeling policies for combination products, biosimilars, and generic drugs on labeling development and product lifecycle practices
- Assess the advantages and limitations of various labeling processes and document management systems commonly used in companies
- Describe global labeling compliance expectations and best practices