Risk Evaluation and Mitigation Strategies Program

Being prepared for the FDA's new inspection program

Date: 29 November 2018
Location: Kfar Maccabiah, Ramat Gan
General Information
Duration: 1 - Day Course
Hours: 9:00 – 17:00
Price: 1,950 NIS + VAT
Credit Points: 1
SKU: 18988
Course Language: English
About the Course
Submission of REMS is a specific FDA requirement that impacts both US and non-US companies planning FDA submissions.
Attending this one-day course will help you understand the REMS program, REMS requirements, how to execute a quality-assured REMS program, and what FDA inspectors specifically look for when evaluating compliance to an approved REMS. Also, learn how you can perform an internal gap analysis or audit to proactively identify, document and mitigate any existing gaps before the FDA shows up with the new compliance guide in their pocket.
On 16 April 2018, the FDA implemented a new compliance program document describing their REMS Inspection program. On September 27, 2007, the Food and Drug Administration Amendments Act (FDAAA), was created. It authorized the FDA to require persons submitting or holding certain applications to submit a proposed Risk Evaluation and Mitigation Strategy (REMS), if the FDA determines that a REMS is necessary to ensure that the benefits of a drug outweigh the risks. An understanding of REMS requirements is important to avoid gaps in FDA submission strategies. An increased focus on REMS calls for increased attention to REMS execution and documentation. If your company has a planned FDA submission or an existing REMS program in the US, don’t be caught off guard.
  • At the completion of this session, you will be able to:
  • Understand and discuss the FDA REMS Program including their new inspector guideline
  • Execute a gap analysis or internal audit to identify existing gaps in your REMS
  • Identify strategies for closing any gaps identified
  • Determine how to best document your gap analysis and strategy to demonstrate due diligence considering that the FDA is ramping up their REMS inspection program.
Who should attend
This course will be of benefit to employees working in a GCP regulated environment who set strategy for, manage, execute, and/or audit pharmaceutical clinical trial and post-marketing activities including but not limited to:
  • Clinical Development
  • Clinical Operations
  • Project Management
  • Regulatory Affairs
  • Medical Writing
  • Quality Systems (Quality Assurance, Training, Document Management, etc.)
  • Drug Safety/Pharmacovigilance
  • Risk Management
Risk Evaluation and Mitigation Strategies Program
Benefits to the Participants
  • Gain an understanding of the FDA REMS Program and the new FDA Inspection Guideline
  • Learn how the requirement for a REMS impacts FDA submission planning  
  • Acquire strategies for implementing and monitoring a compliant REMS that will pass regulatory inspection
  • Obtain a REMS template that can be used immediately for REMS gap analysis and mitigation planning, execution, and documentation.
Contact us
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Issues to be covered
  • Introduction and history of the FDA REMS Program
  • The concepts and requirements of a solid REMS Program
  • The new FDA inspection Guideline
  • Company and vendor roles, responsibilities, and skillsets that may be needed for REMS implementation
  • How to create and document a compliance strategy as soon as possible
About The Lecturer

Ms. Penelope Przekop

Penelope Przekop, RQAP-GCP, is a Quality Management Systems, Assurance & Compliance Consultant with 25 plus years of experience in Pharmaceutical GXP Global Quality Systems with key focus in clinical research and development, data management, computer systems validation, and pharmacovigilance. Her areas of expertise include quality systems quality assurance, regulatory compliance, inspection readiness, training, and strategic planning for quality.
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