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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

Practical Considerations for Robust Evaluation of Risk Minimization Programs: Regulatory, Industry, and Service Provider Insights

Session Chair(s)

Alicia  Gilsenan, PhD, MS, RPh, FISPE

Alicia Gilsenan, PhD, MS, RPh, FISPE

Vice President, Epidemiology

RTI Health Solutions, United States

Evaluation of risk evaluation and mitigation strategies programs in the US or additional risk minimization measures (aRMM) in the EU is required by regulatory bodies in their respective jurisdictions, though the approach, timing, requirements, and available guidance varies. Due to regulatory and cultural differences in global risk minimization practices, successful evaluation of risk minimization programs can be challenging. This forum will share views from varying stakeholder perspectives in the US and Europe for consideration in regulatory discussion, design, and implementation of these programs. Special consideration for practical implementation across different geographic regions in light of a pandemic to meet different regulatory requirements will be discussed. Practical challenges to evaluation implementation (e.g. identification of target population, controlling for selection bias, design options for process and outcome measures and cultural adaptation and consideration—will be discussed. Areas of benefit-risk management and communication will include: Rigorous approaches for evaluation, and practical considerations for planning for evaluation of risk minimization tools Presenters will share examples from their experiences for consideration in the planning, design, and implementation of evaluation of risk minimization programs, with focus on global implementation.

Learning Objective : Identify at least three design considerations for evaluation of risk minimization programs that should not be compromised despite challenges to resource and logistics; Recognize at least two practical considerations in design of evaluation of a global risk minimization program in light of a pandemic.

Speaker(s)

Cynthia  LaCivita, PharmD

Considerations for REMS Evaluation from US Regulatory Perspective

Cynthia LaCivita, PharmD

FDA, United States

Director, Division of Risk Management, OMEPRM, OSE, CDER

Annalisa  Rubino, DrSc, PhD, MSc

Special Considerations for Evaluation of Additional Risk Minimization Measures: European Perspective

Annalisa Rubino, DrSc, PhD, MSc

AstraZeneca, United Kingdom

Director of Epidemiology

Meredith  Smith, PhD, MPA, FISPE

Practical Considerations for Global Evaluation of REMS and aRMM from Industry Perspective

Meredith Smith, PhD, MPA, FISPE

Evidera, Inc, United States

Senior Director, Implementation Science Pillar Lead

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