Topics
- What should you include in proposed modifications of an approved REMS?
- What content must you provide in a proposed Risk Evaluation and Mitigation Strategy (REMS) and what is the format required for a submission?
- How should you communicate with FDA about a REMS?
- What identifiers should you use on REMS documents?
- When do you need to distribute a Medication Guide?
- What do you need to do to update drug safety information?
- When can you take advantage of Shared System REMS?
- What are the key points that you need to know about The Medication Guide Regulations?
- What do you need to know about of the March 2012 Draft Guidance on Drug Safety Information?
Who should Attend
Attendees from pharmaceutical manufacturing, drug, biologic and clinical research companies, including Compliance, Regulatory Affairs, Study Sponsors, Clinical Research Administrators, Senior Management (production, supply chain and operations) and Legal.
