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Establishing an Effective REMS Process:
Significant Implications of Risk Management

WORKSHOP AGENDA

Instructor: Howard Dorfman, Vice President, General Counsel, Ferring Pharmaceuticals

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Day One: Tuesday, November 19, 2013

8:30am – 9:00am

Registration and Continental Breakfast


9:00am – 10:30am

Reviewing the History of REMS and Risk Management

  • Hear an overview of FDA activity relating to risk management
  • Discuss the integration of labeling into the risk management process
  • Uncover FDAAA and its connection with risk management procedures

10:30am – 10:45am

Morning Break


10:45am – 12:30pm

Understanding the Risk Management Process Under the FDAAA

  • Identify general risk provisions of FDAAA including: clinical trials, post approval evaluations, class labeling authority, new DTC authority
  • Examine the FDAAA definition of The Risk Evaluation and Mitigation Strategy (REMS)
  • Interactive Exercise – Analyze the REMS structure and process

12:30pm – 1:30pm

Lunch


1:30pm – 3:00pm

Examining the Influential REMS Guidance: More on the Way?

  • Discuss the stakeholder responses to the REMS guidance
  • Examine the Initial FDA Guidance on REMS
  • Understand existing REMS issues since the REMS guidance was published
  • Interactive Exercise – Issues to be considered and addressed during the REMS process

3:00pm – 3:15pm

Afternoon Break


3:15pm – 5:00pm

Identify Lessons Learned from REMS Programs in Review

  • Uncover the history of approved REMS
  • Analyze the Elements To Assure Safe Use (ETASU)
  • Interactive Exercise – Identify patterns of REMS implementation

5:00pm

Day One Adjourns

Day Two: Wednesday, November 20, 2013

8:00am – 8:30am

Continental Breakfast


8:30am – 10:00am

Integrating Risk Management into the Drug Development Lifecycle

  • Identify potential risk during the early development (IND, Phase I and II)
  • Apply risk mitigation activities during the Phase III process
  • Improve risk identification and minimization post-approval
  • Interactive Exercise – Addressing the continuum of risk

10:00am – 10:15am

Morning Break


10:15pm – 12:00pm

Creating and Developing REMS in the Real World

  • Build REMS as part of the risk mitigation process
  • Understand the impact of the FDA Transparency Initiative on REMS
  • Include medical communication functions as part of risk management
  • Interactive Exercise – Leveraging the cross disciplinary processes

12:00pm – 12:15pm

Break


12:15pm – 1:30pm

Working Boxed Lunch
Discovering the Key Implications of REMS

  • Examine the impact of REMS on product liability exposure
  • Evaluate how REMS intersect with social media
  • Coordinate REMS with effective health care compliance
  • Interactive Exercise – Explore REMS and company functions

1:30pm – 1:45pm

Afternoon Break


1:45pm – 3:00pm

Explore Unresolved REMS Issues: What does the Future Hold?

  • Determine the impact of PDUFA V on Risk management
  • Impact of the OIG Report on REMS Implementation
  • Evaluate the effectiveness of a REMS
  • Seek FDA input and the voluntary REMS
  • Realize the effect of REMS on the practice of medicine and drug utilization
  • Interactive Exercise – Formulate and share best practices

3:00pm

Training Adjourns