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Learnings from Safety Communications Across the Industry: Patients and EMA, REMS and FDA, Physicians and Medical Information Groups
Session Chair(s)
Stacey Fung, PharmD
Head, Global Medical Information
Gilead Sciences, United States
MedWatch from Spontaneous Report to FDA Alert and Beyond: An Overview of Incorporating Safety Information into Practice
Learning Objective : Discuss postmarket safety reporting into MedWatch and the external safety messages communicated by the FDA MedWatch program; Describe the adoption of FDA’s MedWatch safety information at the point-of-care; Discuss how patients participate on the review of product information and safety communication produced by the EMA; Explain physician familiarity with REMS and identify educational tools that medical information groups can provide to ensure safe and effective use of products.
Speaker(s)
Patient Involvement in Preparation of the EMA Information on Medicines: Five Year Experience at the EMA
Martin Harvey Allchurch, LLM
European Medicines Agency, Netherlands
Head of International Affairs
MedWatch from Spontaneous Report to FDA Alert and Beyond: An Overview of Incorporating Safety Information into Practice
Heidi Marchand, PharmD
Gilead Sciences, United States
Executive Director and Head of Global Regulatory Policy and Intelligence
Physician Familiarity with REMS and Role of Medical Information in Safe and Effective Use of Pharmaceutical Products
Inessa Volonueva, PharmD, MS, RPh
Janssen Scientific Affairs, LLC, United States
Associate Director, Medical Information
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