Pharmacovigilance and Risk Management Conference – New Approaches, Tools, and Technologies - June 9-10, 2020

Pharmacovigilance and Risk Management Conference New Approaches, Tools, and Technologies June 9-10, 2020 | Webcast This conference is FREE.

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This training is designed to provide participants with a foundation in regulations, FDA guidances, and risk-based principles aimed at ensuring safety of marketed drug and biological products.  The training will include regulatory approaches to prevent medication errors and the application of regulations and guidances to design labels and labeling to prevent medication errors. FDA will also discuss advances in approaches, tools, and technologies for medication error prevention, pharmacovigilance, and risk management. 

FEATURED TOPICS

• Best Practices in Drug and Biological Product Postmarket Safety Surveillance
• Safety Considerations for Product Design, Container Labels and Carton Labeling to Minimize Medication Errors
• Process for Nonproprietary Name Suffix Review for Biological Products
• FDA’s Sentinel Initiative and Sentinel’s role in safety surveillance
• Overview of the Division of Risk Management and review activities
• Development of Shared System REMS and waivers
• Best practices for developing and reporting surveys for REMS  
• Considerations for REMS Assessments – Planning and Reporting

Continuing Education

This course:

• has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
• has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• has been approved by ACRP for medical education credits. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.
• Continuing education certificates are available only for those who attend real-time. There is a two week deadline to obtain the certificate of attendance and complete the event survey.

KEYNOTE ADDRESS Gerald Dal Pan, MD, MHS Office Director Office of Surveillance and Epidemiology | CDER | FDA

INTENDED AUDIENCE This event is intended for industry, academia, payors, healthcare information providers, and healthcare providers who: review, develop, submit, or use the Prescribing Information, Instructions for Use, and/or carton/container labeling; and regulatory affairs professionals specializing in pharmacovigilance and risk management and labeling MedDRA Dictionary teams; foreign regulators; healthcare professionals specializing in medication errors, REMS, Human factors and adverse events; and patient safety organizations.